Safety Concerns Hit Valneva As Ixchiq Chikungunya Virus Vaccine Is Suspended In US
- Valneva SE VALN stock is trading lower on Monday after the U.S. Food and Drug Administration (FDA) suspended the license for Ixchiq, citing four new reports of serious adverse events (SAEs) consistent with chikungunya-like illness.
- 08/25/2025
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FDA suspends Valneva's chikungunya vaccine license in the U.S.
- The United States Food and Drug Administration (FDA) has suspended the license for Valneva's chikungunya vaccine Ixchiq with immediate effect, the French drugmaker said on Monday.
- 08/25/2025
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Valneva Announces FDA's Decision to Suspend License of Chikungunya Vaccine IXCHIQ® in the U.S.
- Saint Herblain (France), August 25, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the United States Food and Drug Administration (FDA) has suspended the license for IXCHIQ®, citing four new reports of serious adverse events (SAEs) consistent with chikungunya-like illness. The suspension of the license is effective immediately and requires Valneva to stop shipping and selling of IXCHIQ® in the United States.
- 08/25/2025
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Valneva assumed with a Buy at H.C. Wainwright
- H.C. Wainwright analyst Brandon Folkes assumed coverage of Valneva with a Buy rating and $18 price target. The firm says Valneva is a commercial-stage vaccine company with a "strong proprietary portfolio." VLA15 offers a "de-risked, relatively high-probability path" to potential blockbuster sales, the analyst tells investors in a research note.
- 08/19/2025
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Valneva's Chikungunya Vaccine IXCHIQ® Now Authorized in Canada for Individuals Aged 12 and Older
- Saint Herblain (France), August 18, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that Health Canada has granted marketing authorization for its single-dose vaccine, IXCHIQ®, for the prevention of disease caused by the chikungunya virus in individuals aged 12 years and older. This announcement adds to the adult marketing authorization already received in Canada 1 and complements the adolescent label extension received in Europe in April 20252.
- 08/18/2025
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Valneva SE (VALN) Q2 2025 Earnings Call Transcript
- Valneva SE (NASDAQ:VALN ) Q2 2025 Earnings Conference Call August 12, 2025 9:00 AM ET Company Participants Joshua Drumm - Vice President of Investor Relations Peter Buhler - Chief Financial Officer Thomas Lingelbach - President, CEO & Director Conference Call Participants Damien Choplain - Stifel, formerly Bryan Garnier & Co., Research Division Mohamad Amin Makarem - Jefferies LLC, Research Division Rajan Sharma - Goldman Sachs Group, Inc., Research Division Sebastiaan van der Schoot - Unidentified Company Joshua Drumm Thank you, operator. Hello, and thank you for joining us to discuss Valneva's first half 2025 results and corporate update.
- 08/12/2025
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Valneva Reports Half Year 2025 Financial Results and Provides Corporate Updates
- Saint-Herblain (France), August 12, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today reported its condensed consolidated financial results for the first half of the year, ended June 30, 2025, and confirmed its 2025 financial guidance. The half year financial report, including the condensed consolidated interim financial report and the half year management report, is available on the Company's website (Financial Reports – Valneva).
- 08/12/2025
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Valneva Announces Removal of FDA-Recommended Pause on Use of Chikungunya Vaccine IXCHIQ® in Elderly and Updates to the Prescribing Information
- Saint Herblain (France), August 7, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the FDA has removed its recommended pause in the use of IXCHIQ® in individuals 60 years of age and older and has approved updates to the Prescribing Information (PI) for IXCHIQ®. IXCHIQ® remains indicated in the United States for the prevention of disease caused by the Chikungunya Virus (CHIKV) in individuals 18 years of age and older who are at high risk of exposure to CHIKV.
- 08/07/2025
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AGC Biologics' Heidelberg Site Supplies Drug Substance for Phase II Studies of Valneva's Tetravalent Shigella Vaccine Candidate
- SEATTLE & HEIDELBERG, Germany--(BUSINESS WIRE)--AGC Biologics, your friendly CDMO expert, today announced a development and manufacturing services agreement with specialty vaccine company Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) to supply drug substance for an investigational four-valent Shigella bioconjugate vaccine at the CDMO's Heidelberg facility. Valneva exclusively licensed the vaccine candidate from LimmaTech Biologics AG, which previously worked with AGC Biologics to establish GMP.
- 07/29/2025
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Valneva (VALN) Soars 17.4%: Is Further Upside Left in the Stock?
- Valneva (VALN) witnessed a jump in share price last session on above-average trading volume. The latest trend in earnings estimate revisions for the stock doesn't suggest further strength down the road.
- 07/24/2025
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Valneva Announces Lifting of European Medicines Agency's Temporary Restriction on Use of Chikungunya Vaccine IXCHIQ® in Elderly
- Saint Herblain (France), July, 11 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the European Medicines Agency (EMA) will lift the temporary restriction on vaccinating people aged 65 years and above after concluding a thorough review of Valneva's single-dose chikungunya vaccine IXCHIQ® by EMA's safety committee (PRAC). The committee initiated its review at the beginning of May following the occurrence of serious side effects mainly in elderly people with several underlying medical conditions.
- 07/11/2025
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Europe lifts restriction on Valneva's chikungunya vaccine for elderly adults
- The European Union's health regulator has lifted the temporary restriction on the use of French drugmaker Valneva's chikungunya vaccine, Ixchiq, in adults aged 65 and above, following a safety review.
- 07/11/2025
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Valneva Announces Exclusive Vaccine Marketing and Distribution Agreement for Germany with CSL Seqirus
- Saint-Herblain, France, June 26, 2025 – Valneva SE, (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced an exclusive agreement with CSL Seqirus, one of the world's largest influenza vaccine companies, for the marketing and distribution of Valneva's three proprietary vaccines in Germany.
- 06/26/2025
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Valneva Announces Successful Outcome of its Annual General Meeting, Confirms FY 2025 guidance
- Saint-Herblain (France), June 25, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that all the resolutions recommended by the Board of Directors were approved by the shareholders at its Annual General Meeting held today in Lyon, France.
- 06/25/2025
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UK's MHRA suspends Valneva's chikungunya vaccine for elderly
- UK's medicine regulator said on Monday it has temporarily restricted the use of French vaccine maker Valneva's shot to treat chikungunya, a virus transmitted by mosquitoes, in people aged 65 and above as a precautionary measure.
- 06/09/2025
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Valneva Reports Positive Six-Month Antibody Persistence and Safety Phase 2 Results in Children for its Single-Shot Chikungunya Vaccine IXCHIQ®
- Saint-Herblain (France), June 5, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced positive six-month antibody persistence and safety data for its Phase 2 clinical trial evaluating the safety and immunogenicity of two different dose levels of its single-shot chikungunya vaccine, IXCHIQ®, in 304 children. Partially funded by the Coalition for Epidemic Preparedness Innovations (CEPI), with support from the European Union, the trial is intended to support a pivotal Phase 3 study in children, which the Company expects to initiate in the first quarter of 2026, with the objective of extending the product label to this age group.
- 06/05/2025
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Valneva Announces Availability of Documentation for its Combined Shareholder Meeting and Provides Corporate Update
- Saint-Herblain (France), June 4, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company (“the Company”), today announced the availability of documentation for its Combined General Meeting (“the Meeting”) to be held on June 25, 2025 at 2:00 p.m. CEST at the Sofitel Lyon Bellecour Hotel, 20 quai du Docteur Gailleton, 69002 Lyon (France).
- 06/04/2025
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Valneva to Participate at U.S. and European Investor Conferences in June
- Saint-Herblain (France), May 26, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that its senior management will present and hold investor meetings at several upcoming investor conferences in the United States and Europe in June 2025.
- 05/26/2025
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Valneva Provides Update on Recommended Use of IXCHIQ® by Elderly Individuals in the United States
- Saint Herblain (France), May, 12 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the U.S. Food and Drug Association (FDA) and the U.S. Centers for Disease Control and Prevention (CDC), in a joint communication to the medical community, have recommended a pause in the use of Valneva's single-dose live attenuated chikungunya vaccine IXCHIQ® in elderly individuals while ongoing investigations into reported serious adverse events (SAEs) are completed. This update follows an earlier recommendation from the U.S. Advisory Committee on Immunization Practices (ACIP) to include a precaution related to the use of IXCHIQ® in persons aged 65 and over and a similar decision by the European Medicines Agency (EMA) to temporarily suspend the use of the vaccine for individuals over 65 years old pending investigation.
- 05/12/2025
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Valneva SE (VALN) Q1 2025 Earnings Call Transcript
- Valneva SE (NASDAQ:VALN ) Q1 2025 Earnings Conference Call May 7, 2025 9:00 AM ET Company Participants Joshua Drumm - Vice President-Global Investor Relations Thomas Lingelbach - Chief Executive Officer Peter Bühler - Chief Financial Officer Conference Call Participants Maury Raycroft - Jefferies Rajan Sharma - Goldman Sachs Vamil Divan - Guggenheim Securities. Samir Devani - Rx Securities Oscar Haffen Lamm - Bryan, Garnier & Co. Simon Scholes - First Berlin Joshua Drumm Thank you.
- 05/09/2025
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Valneva SE: Still Undervalued Travel Vaccine Bet With Robust 2025 Guidance
- Valneva SE offers exposure to a robust travel vaccine portfolio that includes Ixiaro, Dukoral, and Ixchiq. Ixiaro generated roughly €94.1 million in 2024 and remains Valneva's main revenue vertical. Dukoral contributed with €32.3 million in sales in 2024 and provides some revenue diversification alongside Ixiaro in the traveler-vaccine niche.
- 05/08/2025
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Valneva Provides Update Following European Medicines Agency Announcement on Use of IXCHIQ® in Elderly
- Saint Herblain (France), May, 07 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the European Medicines Agency (EMA) has started a review of Valneva's single-dose live attenuated chikungunya vaccine IXCHIQ® based on reports of serious adverse events (SAEs) in elderly people. As a temporary measure, while this review is ongoing, EMA has suspended the use of the vaccine for individuals over 65 years old. EMA has maintained current recommendations for IXCHIQ® for people from 12 to 64 years of age.
- 05/07/2025
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Europe reviews Valneva's chikungunya vaccine after reports of serious side-effects in older people
- The European Union's health regulator said on Wednesday it has begun a review of Valneva's chikungunya vaccine after reports of serious adverse events in older adults, including two deaths globally.
- 05/07/2025
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Valneva Reports First Quarter 2025 Financial Results and Provides Corporate Updates
- Saint-Herblain (France), May 7, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today reported its financial results for the first quarter ending March 31, 2025, provided key corporate updates and confirmed its 2025 financial guidance. The condensed consolidated interim financial results are available on the Company's website (Financial Reports – Valneva).
- 05/07/2025
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Valneva Provides Update on Recommendation for Use of Its Chikungunya Vaccine by French Authorities
- Saint Herblain (France), April 26, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that France's national public health agency, the Haute Autorité de Santé (HAS), has updated its recommendation for use of Valneva's single-dose chikungunya vaccine IXCHIQ® for the prevention of disease caused by the chikungunya virus (CHIKV) following reports of serious adverse events (SAEs) in elderly people with comorbidities during the ongoing vaccination campaign in La Reunion and Mayotte. Valneva has been responding to the French government's call for vaccine supply of IXCHIQ® in La Reunion1 as the island is going through a major chikungunya outbreak with ~ 40,000 confirmed cases since the beginning of 20252.
- 04/26/2025
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INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Valneva SE - VALN
- NEW YORK, April 25, 2025 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Valneva SE (“Valneva” or the “Company”) (NASDAQ: VALN). Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext. 7980.
- 04/25/2025
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INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Valneva SE - VALN
- NEW YORK CITY, NY / ACCESS Newswire / April 23, 2025 / Pomerantz LLP is investigating claims on behalf of investors of Valneva SE ("Valneva" or the "Company") (NASDAQ:VALN). Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext.
- 04/23/2025
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INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Valneva SE - VALN
- NEW YORK , April 22, 2025 /PRNewswire/ -- Pomerantz LLP is investigating claims on behalf of investors of Valneva SE ("Valneva" or the "Company") (NASDAQ: VALN). Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext.
- 04/22/2025
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INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Valneva SE - VALN
- NEW YORK, April 21, 2025 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Valneva SE (“Valneva” or the “Company”) (NASDAQ: VALN). Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext. 7980.
- 04/21/2025
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INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Valneva SE - VALN
- NEW YORK CITY, NY / ACCESS Newswire / April 20, 2025 / Pomerantz LLP is investigating claims on behalf of investors of Valneva SE ("Valneva" or the "Company") (NASDAQ:VALN). Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext.
- 04/20/2025
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INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Valneva SE - VALN
- NEW YORK CITY, NY / ACCESS Newswire / April 18, 2025 / Pomerantz LLP is investigating claims on behalf of investors of Valneva SE ("Valneva" or the "Company") (NASDAQ:VALN). Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext.
- 04/18/2025
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Valneva Provides Update on ACIP Recommendation for its Chikungunya Vaccine IXCHIQ® Among U.S. Travelers
- Saint Herblain (France), April 18, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that during its regular meeting on April 16, the U.S. Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) updated its recommendation for use of Valneva's single-dose chikungunya vaccine IXCHIQ® for the prevention of disease caused by the chikungunya virus (CHIKV). ACIP maintained its current recommendation for IXCHIQ® for persons aged ≥18 years traveling to a country or territory where there is a chikungunya outbreak. Additionally, it may be considered for persons aged ≥18 years traveling or taking up residence in a country or territory without an outbreak but with elevated risk for U.S. travelers if planning travel for an extended period of time e.g., six months or more.
- 04/18/2025
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INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Valneva SE - VALN
- NEW YORK, April 17, 2025 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Valneva SE (“Valneva” or the “Company”) (NASDAQ: VALN). Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext. 7980.
- 04/17/2025
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INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Valneva SE - VALN
- NEW YORK CITY, NY / ACCESS Newswire / April 16, 2025 / Pomerantz LLP is investigating claims on behalf of investors of Valneva SE ("Valneva" or the "Company") (NASDAQ:VALN). Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext.
- 04/16/2025
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Valneva to Participate in Multiple Events at the 25th World Vaccine Congress, including a Presentation on its Chikungunya Vaccine IXCHIQ®
- Saint-Herblain (France), April 16, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced its presence at the forthcoming 25th World Vaccine Congress, which will take place from April 21-24, 2025 at the Walter E. convention center in Washington, D.C. Under the leadership of the Company´s Chief Executive Officer, Thomas Lingelbach, a team of Valneva´s senior managers will participate in multiple events, including an important presentation on the Company´s vaccine IXCHIQ®, the world's first licensed chikungunya vaccine.
- 04/16/2025
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INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Valneva SE - VALN
- NEW YORK CITY, NY / ACCESS Newswire / April 15, 2025 / NEW YORK, April 15, 2025 (ACCESSWIRE) Pomerantz LLP is investigating claims on behalf of investors of Valneva SE ("Valneva" or the "Company") (NASDAQ:VALN). Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext.
- 04/15/2025
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INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Valneva SE - VALN
- NEW YORK , April 14, 2025 /PRNewswire/ -- Pomerantz LLP is investigating claims on behalf of investors of Valneva SE ("Valneva" or the "Company") (NASDAQ: VALN). Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext.
- 04/14/2025
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Brazil Approves Valneva's Mosquito-Borne Chikungunya Vaccine
- The Brazilian Health Regulatory Agency (ANVISA) has granted marketing authorization to Valneva SE's VALN single-dose vaccine Ixchiq for the prevention of disease caused by the chikungunya virus in individuals 18 years of age and older.
- 04/14/2025
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Valneva Receives First Marketing Authorization for IXCHIQ® in a Chikungunya Endemic Country
- Saint Herblain (France), April 14, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company today announced that the Brazilian Health Regulatory Agency (ANVISA) has granted marketing authorization to its single-dose vaccine IXCHIQ® for the prevention of disease caused by the chikungunya virus in individuals 18 years of age and older. The ANVISA decision marks the world's first approval of a chikungunya vaccine in an endemic country. Part of Valneva's endemic country strategy, this endeavor is supported by the Coalition for Epidemic Preparedness Innovations (CEPI)1, with co-funding from the European Union (EU), and Instituto Butantan2 to support broader access to a chikungunya vaccine in low-and-middle-income countries (LMICs).
- 04/14/2025
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VALN Doses First Infant With Shigella Vaccine in Mid-Stage Study
- Valneva intends to test its experimental Shigella vaccine in nearly 110 infants. Results from this study are expected later this year.
- 04/10/2025
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INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Valneva SE - VALN
- NEW YORK CITY, NY / ACCESS Newswire / April 9, 2025 / Pomerantz LLP is investigating claims on behalf of investors of Valneva SE ("Valneva" or the "Company") (NASDAQ:VALN). Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext.
- 04/09/2025
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Valneva and LimmaTech Announce First Vaccination in Phase 2 Infant Study of Tetravalent Shigella Vaccine Candidate S4V2
- Saint Herblain (France) and Schlieren (Zurich) , April 9, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, and LimmaTech Biologics AG, a clinical-stage biotech company developing vaccines for the prevention of life-threatening diseases, announced today that the first participant has been vaccinated in a Phase 2 infant safety and immunogenicity study of Shigella4V2 (S4V2), the world's most clinically advanced tetravalent bioconjugate vaccine candidate against shigellosis.
- 04/09/2025
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INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Valneva SE - VALN
- NEW YORK , April 8, 2025 /PRNewswire/ -- Pomerantz LLP is investigating claims on behalf of investors of Valneva SE ("Valneva" or the "Company") (NASDAQ: VALN). Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext.
- 04/08/2025
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INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Biohaven Ltd. - BHVN
- NEW YORK, April 07, 2025 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Biohaven Ltd. (“Biohaven” or the “Company”) (NYSE: BHVN). Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext. 7980.
- 04/07/2025
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INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Valneva SE - VALN
- NEW YORK, April 07, 2025 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Valneva SE (“Valneva” or the “Company”) (NASDAQ: VALN). Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext. 7980.
- 04/07/2025
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VALN Investors Have Opportunity to Join Valneva SE Fraud Investigation with the Schall Law Firm
- LOS ANGELES , April 7, 2025 /PRNewswire/ -- The Schall Law Firm, a national shareholder rights litigation firm, announces that it is investigating claims on behalf of investors of Valneva SE ("Valneva" or "the Company") (NASDAQ: VALN) for violations of the securities laws. The investigation focuses on whether the Company issued false and/or misleading statements and/or failed to disclose information pertinent to investors.
- 04/07/2025
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INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Valneva SE - VALN
- NEW YORK CITY, NY / ACCESS Newswire / April 6, 2025 / Pomerantz LLP is investigating claims on behalf of investors of Valneva SE ("Valneva" or the "Company") (NASDAQ:VALN). Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext.
- 04/06/2025
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VALN Investors Have Opportunity to Join Valneva SE Fraud Investigation with the Schall Law Firm
- LOS ANGELES--(BUSINESS WIRE)--VALN Investors Have Opportunity to Join Valneva SE Fraud Investigation with the Schall Law Firm.
- 04/04/2025
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INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Valneva SE - VALN
- NEW YORK CITY, NY / ACCESS Newswire / April 4, 2025 / Pomerantz LLP is investigating claims on behalf of investors of Valneva SE ("Valneva" or the "Company") (NASDAQ:VALN). Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext.
- 04/04/2025
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Valneva SE Shareholding Declaration - March 2025
- Registered office: 6 rue Alain Bombard, 44800 Saint-Herblain (France).
- 04/03/2025
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INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Valneva SE - VALN
- NEW YORK, NY / ACCESS Newswire / April 2, 2025 / Pomerantz LLP is investigating claims on behalf of investors of Valneva SE ("Valneva" or the "Company") (NASDAQ:VALN). Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext.
- 04/02/2025
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INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Valneva SE - VALN
- NEW YORK, NY / ACCESS Newswire / April 1, 2025 / Pomerantz LLP is investigating claims on behalf of investors of Valneva SE ("Valneva" or the "Company") (NASDAQ:VALN). Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext.
- 04/01/2025
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Valneva's Chikungunya Vaccine IXCHIQ® Now Authorized in EU for Adolescents Aged 12 and Above
- With this extension, IXCHIQ ® , the first vaccine against the chikungunya virus (CHIKV), is now available for administration for individuals 12 years of age and older in the European Union (EU).
- 04/01/2025
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INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Valneva SE - VALN
- NEW YORK , March 31, 2025 /PRNewswire/ -- Pomerantz LLP is investigating claims on behalf of investors of Valneva SE ("Valneva" or the "Company") (NASDAQ: VALN). Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext.
- 03/31/2025
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Valneva Submits Adolescent Label Extension Application for its Chikungunya Vaccine, IXCHIQ®, to UK MHRA
- Saint Herblain (France), March 31, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that it has submitted a label extension application to the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom (UK) to potentially expand the use of its chikungunya vaccine, IXCHIQ®, currently approved in adults1, to adolescents aged 12 to 17 years in the UK. This submission follows the recent positive opinion of the European Medicines Agency (EMA) on extension of IXCHIQ® label to adolescents in the European Union (EU)2.
- 03/31/2025
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INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Valneva SE - VALN
- NEW YORK, March 30, 2025 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Valneva SE (“Valneva” or the “Company”) (NASDAQ: VALN). Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext. 7980.
- 03/30/2025
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INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Valneva SE - VALN
- NEW YORK, NY / ACCESS Newswire / March 27, 2025 / Pomerantz LLP is investigating claims on behalf of investors of Valneva SE ("Valneva" or the "Company") (NASDAQ:VALN). Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext.
- 03/27/2025
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INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Valneva SE - VALN
- NEW YORK CITY, NY / ACCESS Newswire / March 27, 2025 / Pomerantz LLP is investigating claims on behalf of investors of Valneva SE ("Valneva" or the "Company") (NASDAQ:VALN). Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext.
- 03/27/2025
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Valneva Renews its Sales Agreement in connection with its Existing At-the-Market (ATM) Program
- Saint-Herblain (France), March 26, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) (“Valneva” or the “Company”), a specialty vaccine company, today announces that it has filed a prospectus supplement as part of the renewal of its registration statement on Form F-3, filed on March 25, 2025 with the U.S. Securities and Exchange Commission (“SEC”) relating to its existing At-the-Market offering facility (the “ATM Program”), which was originally entered into in August 2022 and has not been utilized to-date.
- 03/26/2025
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INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Valneva SE - VALN
- NEW YORK , March 25, 2025 /PRNewswire/ -- Pomerantz LLP is investigating claims on behalf of investors of Valneva SE ("Valneva" or the "Company") (NASDAQ: VALN). Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext.
- 03/25/2025
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Valneva Announces Filing of 2024 Universal Registration Document and US Form 20-F
- Saint-Herblain (France), March 25, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, announced today the filing, on March 24, 2025, of its 2024 Universal Registration Document (URD) with the French Financial Markets Authority (AMF) under the filing number D.25-0140 and its Form 20-F with the U.S. Securities and Exchange Commission (SEC).
- 03/25/2025
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INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Valneva SE - VALN
- NEW YORK, NY / ACCESS Newswire / March 24, 2025 / Pomerantz LLP is investigating claims on behalf of investors of Valneva SE ("Valneva" or the "Company") (NASDAQ:VALN). Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext.
- 03/24/2025
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Valneva Responds to French Government's Call for Vaccine Supply of IXCHIQ® against Chikungunya Outbreak in La Réunion
- Saint Herblain (France), March 24, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that it is responding to the chikungunya outbreak that is rapidly intensifying in France's Island of La Réunion with its vaccine IXCHIQ®. In agreement and with support from the local public health agency, the Agence Régionale de Santé La Réunion, Valneva will provide 40,000 doses starting early April, with an option to provide more, through distribution agreements with the Island's wholesalers. This supply of doses, paid for by the French authorities, is in line with the recommendation of France's national public health agency, the Haute Autorité de Santé (HAS), to prioritize for vaccination adults aged 65 and over, with co-morbidities. IXCHIQ® remains available for purchase in France (mainland and overseas).
- 03/24/2025
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INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Valneva SE - VALN
- NEW YORK CITY, NY / ACCESS Newswire / March 23, 2025 / Pomerantz LLP is investigating claims on behalf of investors of Valneva SE ("Valneva" or the "Company") (NASDAQ:VALN). Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext.
- 03/23/2025
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INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Valneva SE - VALN
- NEW YORK, NY / ACCESS Newswire / March 21, 2025 / Pomerantz LLP is investigating claims on behalf of investors of Valneva SE ("Valneva" or the "Company") (NASDAQ:VALN). Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext.
- 03/21/2025
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Valneva SE (VALN) Q4 2024 Earnings Call Transcript
- Valneva SE (NASDAQ:VALN ) Q4 2024 Earnings Conference Call March 20, 2025 10:00 AM ET Company Participants Joshua Drumm – Vice President-Global Investor Relations Thomas Lingelbach – Chief Executive Officer Peter Bühler – Chief Financial Officer Conference Call Participants Suzanne Van Voorthuizen – Van Lanschot Kempen Samir Devani – Rx Securities Rajan Sharma – Goldman Sachs Oscar Haffen Lamm – Bryan, Garnier Vamil Divan – Guggenheim Securities Maury Raycroft – Jefferies Joshua Drumm Thank you. Hello, and thank you for joining us to discuss Valneva's Full Year 2024 Results and Corporate Update.
- 03/20/2025
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Bronstein, Gewirtz & Grossman, LLC Announces an Investigation Against Valneva SE (VALN) and Encourages Stockholders to Learn More About the Investigation
- NEW YORK CITY, NY / ACCESS Newswire / March 20, 2025 / Bronstein, Gewirtz & Grossman, LLC is investigating potential claims on behalf of purchasers of Valneva SE ("Valneva" or "the Company") (NASDAQ:VALN). Investors who purchased Valneva securities are encouraged to obtain additional information and assist the investigation by visiting the firm's site: bgandg.com/VALN.
- 03/20/2025
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Valneva Reports Full Year 2024 Results and Provides Business Updates and Outlook
- Saint-Herblain (France), March 20, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today reported its consolidated financial results for the year ended December 31, 2024 and provided key corporate updates and guidance for its future results. The consolidated financial results2 are available on the Company's website ( Financial Reports – Valneva ).
- 03/20/2025
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Bronstein, Gewirtz & Grossman, LLC Initiates an Investigation into Allegations Against Valneva SE (VALN) And Encourages Shareholders to Reach Out
- NEW YORK CITY, NY / ACCESS Newswire / March 19, 2025 / Bronstein, Gewirtz & Grossman, LLC is investigating potential claims on behalf of purchasers of Valneva SE ("Valneva" or "the Company") (NASDAQ:VALN). Investors who purchased Valneva securities are encouraged to obtain additional information and assist the investigation by visiting the firm's site: bgandg.com/VALN.
- 03/19/2025
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INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Valneva SE - VALN
- NEW YORK CITY, NY / ACCESS Newswire / March 19, 2025 / Pomerantz LLP is investigating claims on behalf of investors of Valneva SE ("Valneva" or the "Company") (NASDAQ:VALN). Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext.
- 03/19/2025
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Bronstein, Gewirtz & Grossman, LLC Announces an Investigation Against Valneva SE (VALN) and Encourages Shareholders to Learn More About the Investigation
- NEW YORK CITY, NY / ACCESS Newswire / March 18, 2025 / Bronstein, Gewirtz & Grossman, LLC is investigating potential claims on behalf of purchasers of Valneva SE ("Valneva" or "the Company") (NASDAQ:VALN). Investors who purchased Valneva securities are encouraged to obtain additional information and assist the investigation by visiting the firm's site: bgandg.com/VALN.
- 03/18/2025
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INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Valneva SE - VALN
- NEW YORK , March 17, 2025 /PRNewswire/ -- Pomerantz LLP is investigating claims on behalf of investors of Valneva SE ("Valneva" or the "Company") (NASDAQ: VALN). Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext.
- 03/17/2025
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Valneva SE (VALN) Investigation: Bronstein, Gewirtz & Grossman, LLC Encourages Investors to Contact the Firm to Learn More About the Investigation
- NEW YORK CITY, NY / ACCESS Newswire / March 17, 2025 / Bronstein, Gewirtz & Grossman, LLC is investigating potential claims on behalf of purchasers of Valneva SE ("Valneva" or "the Company") (NASDAQ:VALN). Investors who purchased Valneva securities are encouraged to obtain additional information and assist the investigation by visiting the firm's site: bgandg.com/VALN.
- 03/17/2025
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Bronstein, Gewirtz & Grossman, LLC Encourages Valneva SE (VALN) Shareholders to Inquire about Securities Investigation
- NEW YORK CITY, NY / ACCESS Newswire / March 16, 2025 / Bronstein, Gewirtz & Grossman, LLC is investigating potential claims on behalf of purchasers of Valneva SE ("Valneva" or "the Company") (NASDAQ:VALN). Investors who purchased Valneva securities are encouraged to obtain additional information and assist the investigation by visiting the firm's site: bgandg.com/VALN.
- 03/16/2025
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INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Valneva SE - VALN
- NEW YORK, NY / ACCESS Newswire / March 15, 2025 / Pomerantz LLP is investigating claims on behalf of investors of Valneva SE ("Valneva" or the "Company") (NASDAQ:VALN). Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext.
- 03/15/2025
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Bronstein, Gewirtz & Grossman, LLC Is Investigating Valneva SE (VALN) And Encourages Investors to Connect
- NEW YORK CITY, NY / ACCESS Newswire / March 14, 2025 / Bronstein, Gewirtz & Grossman, LLC is investigating potential claims on behalf of purchasers of Valneva SE ("Valneva" or "the Company") (NASDAQ:VALN). Investors who purchased Valneva securities are encouraged to obtain additional information and assist the investigation by visiting the firm's site: bgandg.com/VALN.
- 03/14/2025
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INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Valneva SE - VALN
- NEW YORK, NY / ACCESS Newswire / March 13, 2025 / Pomerantz LLP is investigating claims on behalf of investors of Valneva SE ("Valneva" or the "Company") (NASDAQ:VALN). Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext.
- 03/13/2025
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Bronstein, Gewirtz & Grossman, LLC Encourages Valneva SE (VALN) Stockholders to Inquire about Securities Investigation
- NEW YORK CITY, NY / ACCESS Newswire / March 13, 2025 / Bronstein, Gewirtz & Grossman, LLC is investigating potential claims on behalf of purchasers of Valneva SE ("Valneva" or "the Company") (NASDAQ:VALN). Investors who purchased Valneva securities are encouraged to obtain additional information and assist the investigation by visiting the firm's site: bgandg.com/VALN.
- 03/13/2025
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Bronstein, Gewirtz & Grossman, LLC Announces an Investigation Against Valneva SE (VALN) and Encourages Investors to Learn More About the Investigation
- NEW YORK CITY, NY / ACCESS Newswire / March 12, 2025 / Bronstein, Gewirtz & Grossman, LLC is investigating potential claims on behalf of purchasers of Valneva SE ("Valneva" or "the Company") (NASDAQ:VALN). Investors who purchased Valneva securities are encouraged to obtain additional information and assist the investigation by visiting the firm's site: bgandg.com/VALN.
- 03/12/2025
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Valneva SE (VALN) Investigation: Bronstein, Gewirtz & Grossman, LLC Encourages Shareholders to Contact the Firm to Learn More About the Investigation
- NEW YORK CITY, NY / ACCESS Newswire / March 11, 2025 / Bronstein, Gewirtz & Grossman, LLC is investigating potential claims on behalf of purchasers of Valneva SE ("Valneva" or "the Company") (NASDAQ:VALN). Investors who purchased Valneva securities are encouraged to obtain additional information and assist the investigation by visiting the firm's site: bgandg.com/VALN.
- 03/11/2025
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Bronstein, Gewirtz & Grossman, LLC Is Investigating Valneva SE (VALN) And Encourages Investors to Connect
- NEW YORK CITY, NY / ACCESS Newswire / March 10, 2025 / Bronstein, Gewirtz & Grossman, LLC is investigating potential claims on behalf of purchasers of Valneva SE ("Valneva" or "the Company") (NASDAQ:VALN). Investors who purchased Valneva securities are encouraged to obtain additional information and assist the investigation by visiting the firm's site: bgandg.com/VALN.
- 03/10/2025
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Bronstein, Gewirtz & Grossman, LLC Is Investigating Valneva SE (VALN) And Encourages Stockholders to Connect
- NEW YORK CITY, NY / ACCESS Newswire / March 9, 2025 / Bronstein, Gewirtz & Grossman, LLC is investigating potential claims on behalf of purchasers of Valneva SE ("Valneva" or "the Company") (NASDAQ:VALN). Investors who purchased Valneva securities are encouraged to obtain additional information and assist the investigation by visiting the firm's site: bgandg.com/VALN.
- 03/09/2025
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Valneva SE (VALN) Investigation: Bronstein, Gewirtz & Grossman, LLC Encourages Stockholders to Contact the Firm to Learn More About the Investigation
- NEW YORK CITY, NY / ACCESS Newswire / March 7, 2025 / Bronstein, Gewirtz & Grossman, LLC is investigating potential claims on behalf of purchasers of Valneva SE ("Valneva" or "the Company") (NASDAQ:VALN). Investors who purchased Valneva securities are encouraged to obtain additional information and assist the investigation by visiting the firm's site: bgandg.com/VALN.
- 03/07/2025
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Bronstein, Gewirtz & Grossman, LLC Announces an Investigation Against Valneva SE (VALN) and Encourages Stockholders to Learn More About the Investigation.
- NEW YORK CITY, NY / ACCESS Newswire / March 6, 2025 / Bronstein, Gewirtz & Grossman, LLC is investigating potential claims on behalf of purchasers of Valneva SE ("Valneva" or "the Company") (NASDAQ:VALN). Investors who purchased Valneva securities are encouraged to obtain additional information and assist the investigation by visiting the firm's site: bgandg.com/VALN.
- 03/06/2025
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ATTENTION VALN SHAREHOLDERS: Investors who lost money on Valneva SE are urged to contact Levi & Korsinsky about an ongoing investigation
- NEW YORK, NY / ACCESS Newswire / March 5, 2025 / Levi & Korsinsky notifies investors that it has commenced an investigation of Valneva SE ("Valneva SE") (NASDAQ:VALN) concerning possible violations of federal securities laws. On February 25, 2025, the U.S. Centers for Disease Control and Prevention ("CDC") posted a notice on its website announcing that "CDC is currently investigating five hospitalizations for cardiac or neurologic events following vaccination with IXCHIQ [Valneva's chikungunya virus vaccine] among people 65 years of age and older.
- 03/05/2025
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Bronstein, Gewirtz & Grossman, LLC Encourages Valneva SE (VALN) Investors to Inquire about Securities Investigation
- NEW YORK CITY, NY / ACCESS Newswire / March 5, 2025 / Bronstein, Gewirtz & Grossman, LLC is investigating potential claims on behalf of purchasers of Valneva SE ("Valneva" or "the Company") (NASDAQ:VALN). Investors who purchased Valneva securities are encouraged to obtain additional information and assist the investigation by visiting the firm's site: bgandg.com/VALN.
- 03/05/2025
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Valneva SE Being Investigated on Behalf of Valneva SE Investors. Contact Levi & Korsinsky For Details.
- NEW YORK, NY / ACCESS Newswire / March 4, 2025 / Levi & Korsinsky notifies investors that it has commenced an investigation of Valneva SE ("Valneva SE") (NASDAQ:VALN) concerning possible violations of federal securities laws. On February 25, 2025, the U.S. Centers for Disease Control and Prevention ("CDC") posted a notice on its website announcing that "CDC is currently investigating five hospitalizations for cardiac or neurologic events following vaccination with IXCHIQ [Valneva's chikungunya virus vaccine] among people 65 years of age and older.
- 03/04/2025
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INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Valneva SE - VALN
- NEW YORK , March 4, 2025 /PRNewswire/ -- Pomerantz LLP is investigating claims on behalf of investors of Valneva SE ("Valneva" or the "Company") (NASDAQ: VALN). Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext.
- 03/04/2025
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Levi & Korsinsky Reminds Shareholders of an Investigation into Valneva SE (VALN) Regarding Potential Securities Fraud Allegations
- NEW YORK, NY / ACCESS Newswire / March 4, 2025 / Levi & Korsinsky notifies investors that it has commenced an investigation of Valneva SE ("Valneva SE") (NASDAQ:VALN) concerning possible violations of federal securities laws. On February 25, 2025, the U.S. Centers for Disease Control and Prevention ("CDC") posted a notice on its website announcing that "CDC is currently investigating five hospitalizations for cardiac or neurologic events following vaccination with IXCHIQ [Valneva's chikungunya virus vaccine] among people 65 years of age and older.
- 03/04/2025
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Bronstein, Gewirtz & Grossman, LLC Initiates an Investigation into Allegations Against Valneva SE (VALN) And Encourages Investors to Reach Out
- NEW YORK CITY, NY / ACCESS Newswire / March 4, 2025 / Bronstein, Gewirtz & Grossman, LLC is investigating potential claims on behalf of purchasers of Valneva SE ("Valneva" or "the Company") (NASDAQ:VALN). Investors who purchased Valneva securities are encouraged to obtain additional information and assist the investigation by visiting the firm's site: bgandg.com/VALN.
- 03/04/2025
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Valneva to Present at Upcoming TD Cowen and Van Lanschot Kempen Healthcare Investor Conferences
- Saint-Herblain (France), March 3, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) a specialty vaccine company, today announced that its senior management will participate at upcoming investor conferences in the United States and Europe. CEO Thomas Lingelbach and CFO Peter Bühler will present at the TD Cowen 45th Annual Health Care Conference, taking place March 3 - 5, 2025, in Boston, MA. Mr. Lingelbach and Mr. Peter Bühler will also meet with institutional investors during the Van Lanschot Kempen Life Sciences Conference, held April 2 - 3, 2025, in Amsterdam, The Netherlands.
- 03/03/2025
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Valneva Receives EMA's Positive CHMP Opinion for Adolescent Label Extension for Chikungunya Vaccine IXCHIQ®
- If granted, IXCHIQ ® will become the first vaccine against the chikungunya virus (CHIKV) available in the EU for adolescents 12 years of age and older
- 02/28/2025
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Valneva Reports Preliminary Unaudited 2024 Revenue and Cash and Provides 2025 Outlook
- Met 2024 growth targets for sales revenue (+13% vs 2023) and total revenues (+10% vs 2023) Strong year-end cash position of €168.3 million Substantial clinical and regulatory progress in 2024, leading to multiple anticipated data readouts, product approvals and label extensions in 2025 2025 outlook reflects solid revenue growth and positive commercial cash flows to support strategic R&D investments with lower operating cash burn Saint-Herblain (France), February 18, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) a specialty vaccine company, today reported its preliminary unaudited full-year 2024 revenue and cash results1 and provided a 2025 outlook. The Company will publish its 2024 audited consolidated financial statements and host an analyst call on March 20, 2025.
- 02/18/2025
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Valneva Receives Marketing Authorization in the UK for the World's First Chikungunya Vaccine, IXCHIQ®
- Saint Herblain (France), February 5, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization in the United Kingdom (UK) for the world's first and only chikungunya vaccine, IXCHIQ®. The single-dose vaccine is indicated for active immunization for the prevention of disease caused by chikungunya virus (CHIKV) in individuals 18 years of age and older. The vaccine is manufactured at Valneva's leading vaccine production site in Livingston, Scotland.
- 02/05/2025
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Valneva Announces New IXIARO® Supply Contract with the U.S. Government Worth a Minimum of $32.8 Million
- Saint Herblain (France), January 30, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced the signing of a new $32.8 million contract with the United States (U.S.) Department of Defense (DoD) for the supply of its Japanese encephalitis (JE) vaccine, IXIARO®.Under this new one-year contract, the DoD will buy a minimum of $32.8 million worth of IXIARO® vaccines and has the possibility to purchase additional doses during the coming twelve months. Deliveries of IXIARO® doses have continued in 2024 under the supply contract signed in September 20231. The new contract will commence immediately.
- 01/30/2025
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Valneva Is A 'Buy' As A First-Mover In Chikungunya
- Valneva Is A 'Buy' As A First-Mover In Chikungunya
- 01/23/2025
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Valneva Reports Positive Phase 2 Results in Children for its Chikungunya Vaccine and Announces Phase 3 Dose Decision
- Saint-Herblain (France), January 22, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) today announced positive results for its Phase 2 clinical trial evaluating the safety and immunogenicity of two different dose levels of its single-shot chikungunya vaccine, IXCHIQ®, in 304 children. Partially funded by the Coalition for Epidemic Preparedness Innovations (CEPI), with support from the European Union, the trial is intended to support a pivotal Phase 3 study in children, which the Company expects to initiate in the fourth quarter of 2025, with the objective to extend the product label to this age group.
- 01/22/2025
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Valneva Vaccine Shows Sustained Immune Response In Adolescents One Year After Single Shot
- On Tuesday, Valneva SE VALN reported Phase 3 data in adolescents for its single-shot chikungunya virus (CHIKV) vaccine, Ixchiq.
- 01/21/2025
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Favorable VLA1553-321 Phase 3 Study Results Boost VALN Stock
- Valneva reports positive data from its Phase 3 - VLA1553-321 study of the IXCHIQ vaccine.
- 01/21/2025
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Valneva Reports High Sustained Immune Response in Adolescents One Year After Single Vaccination with its Chikungunya Vaccine
- Saint-Herblain (France), January 20, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today reported further positive Phase 3 data in adolescents for its single-shot chikungunya virus (CHIKV) vaccine, IXCHIQ®, which showed a sustained 98.3% sero-response rate one-year after single vaccination. These results support and strengthen the pivotal data previously reported for adolescents (12 to 17 years old) which supported filing for potential label extension to this age group in the U.S.1, Europe, and Canada2. Data from this trial are also expected to support licensure of IXCHIQ® in Brazil, which would be the first potential approval for use in endemic populations.
- 01/20/2025
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Valneva to Meet with Investors during the J.P. Morgan Healthcare Conference
- Saint Herblain (France), January 6, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announces that members of its management team will meet one-on-one with existing shareholders and hold meetings with other institutional specialist investors during the 43nd Annual J.P. Morgan Healthcare Conference, January 13-15, 2025 in San Francisco.
- 01/06/2025
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Valneva Announces Peer-Reviewed Publication on the Global Health and Economic Burden of Chikungunya in The British Medical Journal
- Saint-Herblain (France), December 4, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announces the publication of an article on the global health and economic burden of mosquito-borne disease chikungunya in The British Medical Journal (BMJ), one of the world's leading peer-reviewed medical journals.
- 12/04/2024
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Valneva Reports Positive Three-Year Antibody Persistence Data for its Single-Shot Chikungunya Vaccine IXCHIQ®
- Saint-Herblain (France), December 3, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today reported positive antibody persistence data three years after vaccination with a single dose of its chikungunya vaccine IXCHIQ®. The results are in line with Valneva's expectations for this vaccine, confirming a strong and long-lasting antibody persistence across all age groups investigated. The three-year persistence data are also in line with positive twelve-month and two-year persistence data the Company reported in December 20221 and 20232, respectively.
- 12/03/2024
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Chikungunya Vaccine Label Extension Call Likely to Support VALN Stock
- The FDA application complements recent label extension submissions to the EMA and Health Canada, highlighting Valneva's strategic push to enhance IXCHIQ's global reach.
- 11/28/2024
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Valneva Submits Label Extension Application for its Chikungunya Vaccine, IXCHIQ®, to the U.S. FDA
- To potentially include adolescents and antibody persistence up to two years Saint Herblain (France), November 26, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that it has submitted a label extension application to the U.S. Food and Drug Administration (FDA) to potentially extend the use of its chikungunya vaccine IXCHIQ®, which is currently approved in adults, to adolescents aged 12 to 17 years. The application also includes adding the two-year antibody persistence data to the product label, which is a key differentiator for IXCHIQ®.
- 11/26/2024
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European And US Vaccine Stocks Are Under Pressure - Here's WHy
- Some large European and U.S. vaccine maker stocks have fallen in reaction to Robert F. Kennedy Jr.'s nomination to lead the Department of Health and Human Services.
- 11/15/2024
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Valneva and LimmaTech Announce First Vaccination in Phase 2b Human Challenge Study of Tetravalent Shigella Vaccine Candidate S4V2
- Saint Herblain (France) and Schlieren (Zurich) , November 13, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, and LimmaTech Biologics AG, a clinical-stage biotech company developing vaccines for the prevention of life-threatening diseases, announced today that the first participant has been vaccinated in a Phase 2b controlled human infection model (CHIM) study of Shigella4V2 (S4V2), the world's most clinically advanced tetravalent bioconjugate shigellosis vaccine candidate, for which Valneva obtained an exclusive worldwide license from LimmaTech1.
- 11/13/2024
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Valneva SE (VALN) Q3 2024 Earnings Call Transcript
- Valneva SE (NASDAQ:VALN ) Q3 2024 Earnings Conference Call November 7, 2024 9:00 AM ET Company Participants Thomas Lingelbach - Chief Executive Officer Peter Buhler - Chief Financial Officer Joshua Drumm - Vice President of Investor Relations Conference Call Participants Maury Raycroft - Jefferies Chiara Montironi - Van Lanschot Kempen Ed White - HC Wainwright Rajan Sharma - Goldman Sachs Samir Devani - Rx Securities Joshua Drumm Thank you for joining us to discuss Valneva's Financial Results for the First Nine Months of 2024 and a Corporate Update. It's my pleasure to welcome you today.
- 11/09/2024
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Valneva Reports Nine-Month 2024 Financial Results and Provides Corporate Updates
- Nine-Month Key Financial Highlights Total revenues of €116.6 million, including product sales of €112.5 million Net Profit of €24.7 million, including proceeds from the Priority Review Voucher (PRV)1 sale Operating profit of €34.2 million compared to an operating loss of €57.2 million in the first nine-months of 2023 Cash position of €156.3 million Includes €61.2 million in gross proceeds from recent private placement2 Lower cash burn expected in the second half of 2024 as cost contributions to the agreed R&D budget for partnered Lyme disease program were completed in the second quarter of the year Full-year 2024 Financial Guidance Narrowed Expected total product sales according to guidance between €160 million to €170 million and currently anticipated total revenues between €170 million and €180 million Expected R&D investments between €65 million and €75 million Expected Other income between €100 million and €110 million, including €95 million from the PRV sale Launch of the world's first chikungunya vaccine in Canada and Europe underway; Further potential approvals expected in Brazil (Q4 2024) and the UK (Q1 2025); Strategic Pipeline Expansion, Strong Clinical and Regulatory Execution Secured exclusive worldwide license for S4V2 Shigella vaccine candidate, adding an attractive Phase 2 clinical asset to Valneva's R&D pipeline3 - recently granted FDA Fast Track4 Submitted key label extension(s) for IXCHIQ® in Europe and Canada5 Published IXCHIQ® two-year antibody persistence and safety data in the Lancet Infectious Diseases6 further demonstrating the vaccine's highly differentiated immunological profile Awarded new $41.3 million CEPI grant7 to contribute significantly to IXCHIQ® Phase 4 costs and other studies supporting broader access to the vaccine Pfizer completed primary vaccination (three doses) in Phase 3 VALOR Lyme disease trial8 Advancing Phase 1 clinical trial for second-generation Zika vaccine candidate toward expected data readout and further decision on potential development path in 20259 Financial Information (Unaudited results, consolidated per IFRS) € in million Nine months ended September 30, 2024 2023 Total Revenues 116.6 111.8 Product Sales 112.5 106.1 Net profit/(loss) 24.7 -69.3 Adjusted EBITDA10 48.6 -46.0 Cash 156.3 171.3 Saint-Herblain (France), November 7, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today reported consolidated financial results for the first nine months of the year, ended September 30, 2024. The condensed consolidated interim financial results are available on the Company's website ( Financial Reports – Valneva ).
- 11/07/2024
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Valneva to Present on Chikungunya at Several Leading Scientific Conferences
- Saint-Herblain (France), October 21, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, announces today that members of its senior leadership team will present datasets on the world's first and only approved chikungunya vaccine, IXCHIQ®, at several leading scientific conferences during the fourth quarter of 2024.
- 10/21/2024
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Valneva and LimmaTech Awarded FDA Fast Track Designation for Tetravalent Shigella Vaccine Candidate S4V
- Saint Herblain (France) and Schlieren (Zurich), October 16, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, and LimmaTech Biologics AG, a clinical-stage biotech company developing vaccines for the prevention of life-threatening diseases, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Shigella4V (S4V), the world's most clinically advanced tetravalent bioconjugate shigellosis vaccine candidate, for which Valneva obtained an exclusive worldwide license from LimmaTech.
- 10/16/2024
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Valneva Hosts Investor Day in New York City
- Live event and webcast TODAY at 10 AM ET Saint Herblain (France), October 10, 2024 –Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, is hosting an investor day today in New York City to discuss the Company's key value drivers over the next 12-18 months and beyond. Valneva's Chief Executive Officer Thomas Lingelbach, Chief Financial Officer Peter Bühler, and other members of the Company's senior leadership team will highlight the Company's substantial opportunity for its Lyme disease vaccine candidate led by partner Pfizer, Valneva's growing commercial vaccine business, and opportunities for continued value creation from the Company's promising R&D pipeline.
- 10/10/2024
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Valneva to Host Investor Day in New York on Thursday, October 10, 2024 at 10:00 AM ET
- Saint Herblain (France), October 3, 2024 –Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that it will host an investor day at the Lotte New York Palace Hotel in New York, NY on Thursday, October 10, 2024 at 10:00 AM ET (4:00 pm CET). The meeting will be conducted in a hybrid way – in person and webcast. To register, click here.
- 10/03/2024
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Valneva Submits Label Extension Applications for its Chikungunya Vaccine, IXCHIQ®, to EMA and Health Canada
- To potentially include adolescents and antibody persistence up to two years Saint Herblain (France), September 18, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that it has submitted label extension applications to the European Medicines Agency (EMA) and Health Canada to potentially expand the use of its chikungunya vaccine, IXCHIQ®, to adolescents aged 12 to 17 years in Europe and Canada. The Canadian label extension application also includes two-year antibody persistence data, which is a key differentiator for IXCHIQ® that was already included in the initial EMA filing.
- 09/18/2024
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Valneva Announces the Success of its Private Placement Raising approximately €60 Million
- Saint-Herblain (France), September 13, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) (“Valneva” or the “Company”), a specialty vaccine company, today announces the successful pricing of its Private Placement (as defined below) for a final amount of €61,180,000.
- 09/13/2024
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Valneva Announces the Launch of a Private Placement of Ordinary Shares for Approximately 60 Million Euros
- Saint-Herblain (France), September 12, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) (“Valneva” or the “Company”), a specialty vaccine company, today announces its intention to issue, subject to market conditions, approximately 22.6 million new ordinary shares (the “Offer Shares”) at a price of €2.66 per Offer Share to certain categories of investors via a private placement through an accelerated bookbuilding process starting immediately.
- 09/12/2024
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Favorable VLA15 Phase 2 Study Results Might Boost VALN Stock
- Valneva and Pfizer report positive immunogenicity and safety data from their Phase 2 study of the VLA15 vaccine. Phase 3 trials for VLA15 are in progress.
- 09/03/2024
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Pfizer and Valneva report positive results in mid-stage trial of Lyme disease vaccine
- The Phase 2 trial was evaluating the vaccine called VLA15 following a second booster dose given one year after the first one.
- 09/03/2024
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Valneva and Pfizer Report Further Positive Phase 2 Booster Results for Lyme Disease Vaccine Candidate
- Saint-Herblain (France) and New York, NY, September 3, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) and Pfizer Inc. (NYSE: PFE) announced today positive immunogenicity and safety data from their VLA15-221 Phase 2 study following a second booster vaccination of their Lyme disease vaccine candidate, VLA15, given one year after receiving the first booster dose. The immune response and safety profile of VLA15 one month after receiving the second booster dose were similar to those reported after receiving the first booster dose, showing compatibility with the anticipated benefit of a booster vaccination prior to each Lyme season. There are currently no approved human vaccines for Lyme disease, and VLA15 is the Lyme disease vaccine candidate which has advanced the furthest along the clinical development timeline, with two Phase 3 trials in progress. The Centers for Disease Control and Prevention (CDC) has estimated that approximately 476,000 people in the U.S. are diagnosed and treated for Lyme disease each year and 129,000 cases are reported annually in Europe.1 , 2
- 09/03/2024
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Wall Street Analysts Predict a 150.41% Upside in Valneva (VALN): Here's What You Should Know
- The consensus price target hints at a 150.4% upside potential for Valneva (VALN). While empirical research shows that this sought-after metric is hardly effective, an upward trend in earnings estimate revisions could mean that the stock will witness an upside in the near term.
- 09/02/2024
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How Much Upside is Left in Valneva (VALN)? Wall Street Analysts Think 135.3%
- The consensus price target hints at a 135.3% upside potential for Valneva (VALN). While empirical research shows that this sought-after metric is hardly effective, an upward trend in earnings estimate revisions could mean that the stock will witness an upside in the near term.
- 08/15/2024
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Valneva Reports Half Year 2024 Financial Results and Provides Corporate Updates
- First-Half Sales Performance in Line with Full-Year 2024 Guidance Total revenues of €70.8 million, including product sales of €68.3 million, in line with anticipated supply and sales phasing Net Profit of €34.0 million, including proceeds from PRV sale Operating profit of €46.7 million compared to an operating loss of €35.0 million in the first half of 2023 Cash position of €131.4 million Substantially lower cash burn expected in the second half of 2024 as Valneva completed its cost contributions to the agreed R&D budget for its partnered Lyme disease program in the second quarter Significantly extended cash runway with update of debt financing agreement1 Full-year 2024 Financial Guidance Confirmed Expected total revenues between €170 million and €190 million, including €160 million to €180 million of product sales Expected R&D investments between €60 million and €75 million Expected Other income between €100 million and €110 million, including €95 million from the PRV sale Strategic Pipeline Expansion, Strong Clinical and Regulatory Execution Exclusive worldwide license for S4V Shigella vaccine candidate, adding an attractive Phase 2 clinical asset to Valneva's R&D pipeline without impacting full-year or mid-term financial guidance2 Additional marketing authorizations for single-shot IXCHIQ® granted in Europe and Canada ahead of initial guidance; Ongoing regulatory reviews in the UK and Brazil; Recommended by ACIP and adopted by U.S. CDC3 New CEPI grant4 of $41.3 million contributes significantly to Phase 4 costs and other studies supporting broader access to the world's first chikungunya vaccine Reported positive six-month data for Phase 3 adolescent study of IXCHIQ® 5; expects to submit label extensions for 12 to 17 years old in the U.S., Europe and Canada in the second half of 2024 IXCHIQ® two-year antibody persistence data published in the Lancet Infectious Diseases IXCHIQ® pediatric Phase 2 study fully enrolled Completed primary vaccinations (three doses) of VALOR Lyme disease Phase 3 trial participants6 Initiated Phase 1 clinical trial for second-generation Zika vaccine candidate7 Financial Information (Unaudited results, consolidated per IFRS) € in million 6 months ended June 30, 2024 2023 Total revenues 70.8 73.7 Product sales 68.3 69.7 Net profit / loss 34.0 (35.0) Adjusted EBITDA8 56.2 (28.3) Cash 131.4 204.4 Saint-Herblain (France), August 13, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today reported its consolidated financial results for the first half of the year, ended June 30, 2024. The half year financial report, including the condensed consolidated interim financial report and the half year management report, is available on the Company's website (Financial Reports – Valneva).
- 08/13/2024
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Valneva and LimmaTech Enter into a Strategic Partnership to Accelerate the Development of the World's Most Clinically Advanced Tetravalent Shigella Vaccine Candidate
- Saint-Herblain (France) and Schlieren (Zurich), August 1, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company and LimmaTech Biologics AG, a clinical-stage biotech company developing vaccines for the prevention of life-threatening diseases, today announced that the companies have entered into a strategic partnership and exclusive licensing agreement for the development, manufacturing and commercialization of Shigella4V (S4V), a tetravalent bioconjugate vaccine candidate against shigellosis.
- 08/01/2024
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3 Promising Biotech Stocks You Can Pick Up for Less Than $10
- What could be better than viable enterprises within the biotechnology industry? Try biotech stocks under $10.
- 07/29/2024
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Can Valneva (VALN) Climb 149.04% to Reach the Level Wall Street Analysts Expect?
- The consensus price target hints at a 149% upside potential for Valneva (VALN). While empirical research shows that this sought-after metric is hardly effective, an upward trend in earnings estimate revisions could mean that the stock will witness an upside in the near term.
- 07/26/2024
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CEPI Expands Partnership with Valneva with a $41.3 Million Grant to Support Broader Access to the World's First Chikungunya Vaccine
- Oslo, Norway, and Saint-Herblain, France, July 22, 2024—The Coalition for Epidemic Preparedness Innovations (CEPI) and Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, have expanded their partnership to support broader access to the world's first chikungunya vaccine, IXCHIQ®, in Low- and Middle-Income countries (LMICs), as well as post-marketing trials and potential label extensions in children, adolescents and pregnant women.
- 07/22/2024
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Phase 3 VALOR Lyme Disease Trial: Valneva and Pfizer Announce Primary Vaccination Series Completion
- New York, NY and Saint-Herblain (France), July 17, 2024 – Pfizer Inc. (NYSE: PFE) and Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) today announced that the participants of the Phase 3 trial “Vaccine Against Lyme for Outdoor Recreationists” (VALOR) have completed the primary vaccination series (three doses) of Lyme disease vaccine candidate VLA15. Participants will be monitored for the occurrence of Lyme disease cases until the end of the Lyme disease season in 2025.1 ,
- 07/17/2024
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Valneva (VALN) Gets EC's Approval on Chikungunya Vaccine
- Valneva (VALN) gets European Commission???s marketing authorization in Europe for Valneva?
- 07/08/2024
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Valneva Receives Marketing Authorization in Europe for the World's First Chikungunya Vaccine, IXCHIQ®
- Saint Herblain (France), July 1, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the European Commission (EC) has granted marketing authorization in Europe for Valneva's single-dose vaccine, IXCHIQ®, for the prevention of disease caused by the chikungunya virus in individuals 18 years of age and older. The approval was unanimously endorsed by Member States following a stringent assessment by the European Medicines Agency (EMA)1. The EC decision marks the third approval the Company has received for IXCHIQ® following approval from the U.S. Food and Drug Administration (FDA) in November 2023 and Health Canada last month2. The Company expects to deliver the first doses in Europe in the fourth quarter of 2024.
- 07/01/2024
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Valneva Announces Successful Outcome of its Combined General Meeting and Appointment of a New Director to its Board
- Saint-Herblain (France), June 26, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that all the resolutions recommended by the Board of Directors were approved by the shareholders at its Combined General Meeting (CGM) held today in Lyon, France.
- 06/26/2024
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Valneva's (VALN) CHIKV Vaccine Gets Health Canada's Approval
- Valneva's (VALN) IXCHIQ, the world's only licensed chikungunya vaccine, is a critical tool in combating this public health threat.
- 06/24/2024
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Valneva Announces Health Canada Approval of the World's First Chikungunya Vaccine, IXCHIQ®
- Saint-Herblain (France), June 24, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that Health Canada has approved IXCHIQ®, Valneva's single-dose vaccine for the prevention of disease caused by the chikungunya virus in individuals 18 years of age and older. This decision marks the second approval the Company has received for IXCHIQ® following approval from the U.S. Food and Drug Administration (FDA) in November 2023. The European Medicines Agency (EMA) also recently recommended marketing authorization of the vaccine in Europe, and a formal decision is expected in the third quarter of 2024.
- 06/24/2024
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Valneva Announces Availability of Documentation for its Combined Shareholder Meeting and Provides Corporate Update
- Saint-Herblain (France), June 5, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company (“the Company”), today announced the availability of documentation for its Combined General Meeting (“the Meeting”) to be held on June 26, 2024 at 2:00 p.m. CEST at the Sofitel Lyon Bellecour Hotel, 20 quai du Docteur Gailleton, 69002 Lyon (France).
- 06/05/2024
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Valneva to Present and Hold Investor Meetings at Upcoming Conferences in June
- Saint-Herblain (France), June 4, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that management will participate at several upcoming investor conferences in the United States and Europe during June 2024.
- 06/04/2024
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Valneva Announces Publication of Lyme Disease Phase 2 Trials in the Lancet Infectious Diseases
- Saint-Herblain (France), June 3, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the results of two Phase 2 clinical trials of Lyme disease vaccine candidate, VLA15, were published in the peer-reviewed medical journal, The Lancet Infectious Diseases. These trials, as well as a third Phase 2 trial in pediatric participants, supported the design of the current pivotal Phase 3 trial, ‘Vaccine Against Lyme for Outdoor Recreationists' (VALOR).
- 06/03/2024
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Valneva Receives EMA's Positive CHMP Opinion for its Chikungunya Vaccine
- Saint Herblain (France), May 31, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending authorization of Valneva's single-dose vaccine for the prevention of disease caused by the chikungunya virus in individuals 18 years of age and older.
- 05/31/2024
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EU regulator recommends use of Valneva's chikungunya vaccine
- The European Medicines Agency (EMA) recommended the use of Valneva's single-shot vaccine for chikungunya virus, the regulator said on Friday.
- 05/31/2024
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Valneva Appoints Dr. Hanneke Schuitemaker, Ph.D. as Chief Scientific Officer
- Saint-Herblain (France), May 21, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced the appointment of Dr. Hanneke Schuitemaker, Ph.D. as Chief Scientific Officer (CSO) and Executive Committee member, effective June 3, 2024.
- 05/21/2024
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Valneva Reports Further Positive Pivotal Phase 3 Data in Adolescents for its Single-Shot Chikungunya Vaccine
- Results Intended to Support Filing for Potential Label Extension for Use in Adolescents Saint-Herblain (France), May 13, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today reported further positive pivotal Phase 3 data in adolescents for its single-shot chikungunya virus (CHIKV) vaccine. Following the initial analysis up to Day 29 post-vaccination, the most recent analysis of study VLA1553-321 evaluated the safety and immunogenicity six months (Day 180) after vaccination with a single dose of the vaccine.
- 05/13/2024
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Valneva Reports First Quarter 2024 Financial Results and Provides Corporate Updates
- Valneva Reports First Quarter 2024 Financial Results and Provides Corporate Updates Q1 financial highlights Total revenues of €32.8 million, including sales of €32.1 million, on track to meet anticipated full year guidance Cash position of €176.6 million, including €95 million from sale of Priority Review Voucher (PRV)1. Significantly extended cash runway with recent update of debt financing agreement2 Substantially lower cash burn expected in 2024 as Valneva expects to complete its cost contributions for the Lyme disease Phase 3 study in the second quarter Net Profit of €58.9 million, reflecting PRV sale 2024 financial guidance confirmed Expected total revenues between €170 million and €190 million, including: €160 million to €180 million of sales driven by growth of Valneva's proprietary products Expected R&D investments between €60 million and €75 million, mostly dedicated to ongoing chikungunya development activities, the Zika trial and advancement of pre-clinical programs Expected Other income between €100 million and €110 million, reflecting €95 million in proceeds from the PRV sale Strong R&D execution Single-shot chikungunya vaccine IXCHIQ® recommended by ACIP and adopted by U.S. CDC3; Regulatory processes with the European, Canadian and Brazilian authorities on track; Six-month data for Phase 3 adolescent study of IXCHIQ® to be reported shortly and label extensions to be submitted based on results; Enrolment of children for pediatric Phase 2 study on track; Primary vaccinations for all participants in the VALOR Lyme disease Phase 3 trial expected to be completed in Q2; Phase 1 clinical trial for second-generation Zika vaccine candidate initiated4.
- 05/07/2024
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Valneva Initiates Phase 1 Trial of Second-Generation Zika Vaccine Candidate
- Saint-Herblain (France), March 26, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced the initiation of a Phase 1 clinical trial to investigate the
- 03/26/2024
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Valneva Announces Filing of 2023 Universal Registration Document and US Form 20-F
- Saint-Herblain (France), March 25, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, announced today the filing, on March 22, 2024, of its 2023 Universal Registration Document (URD) with the French Financial Markets Authority (AMF) under the filing number D.24-0157 and its Form 20-F with the U.S. Securities and Exchange Commission (SEC).
- 03/25/2024
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Valneva to Present on its Chikungunya Vaccine IXCHIQ®, Participate in Multiple Events at the 24th World Vaccine Congress in Washington D.C.
- Saint-Herblain (France), March 21, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced it will present on its single-shot chikungunya vaccine, IXCHIQ®, moderate a roundtable on the Zika and chikungunya viruses, and participate in a panel discussion on efforts to eradicate chikungunya at the 24th World Vaccine Congress, which will take place between April 1-4, 2024 at the Walter E. Washington convention center in Washington, D.C. The Company will have a display in the exhibit area of the congress at booth #433.
- 03/21/2024
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Valneva SE (VALN) Q4 2023 Earnings Call Transcript
- Valneva SE (VALN) Q4 2023 Earnings Call Transcript
- 03/20/2024
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French biotech company Valneva raises product sales guidance
- French biotech company Valneva on Wednesday raised its product sales guidance and said it now expects revenues of between 170 million euros and 190 million euros ($184.72 million to $206.45 million) in 2024, as it anticipates sales growth of its travel vaccines and the launch of Ixiaro.
- 03/20/2024
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Valneva Reports Full Year 2023 Results and Provides Business Updates and Outlook
- Total revenues of €153.7 million, including product sales of €144.6 million Product sales surpassed pre-pandemic (2019) sales by 12% and 2022 sales by 26% Excluding COVID-19 vaccine sales, product sales grew by 63% compared to 2022 Cash position of €126.1 million at year-end 2023 enhanced by €95 million from sale of Priority Review Voucher (PRV) 1 Extended the interest-only period of existing debt financing agreement to January 2026 significantly extending cash runway2 Operational business considered sufficiently funded (excluding debt repayment) until commercial revenues from Lyme program enable sustained profitability Excellent progress across R&D pipeline Approval of single-shot chikungunya vaccine IXCHIQ® in the United States (U.S.) The world's first and only vaccine to address this significant unmet medical need U.S. CDC recently adopted ACIP recommendations3 Regulatory reviews ongoing in Europe, Canada and Brazil Completion of recruitment for Lyme disease Phase 3 study conducted in collaboration with Pfizer All execution milestones on track Advancing second-generation ZIKA vaccine candidate into Phase 1 clinical trial Addressing a re-emerging medical need Updated FY 2024 guidance Valneva raises its 2024 product sales4 guidance to between €160 million and €180 million due to an improved outlook regarding the IXIARO® supply constraints that were anticipated in February 2024.As such, 2024 total revenues are now expected to reach between €170 million and €190 million compared to €153.7 million in 2023, driven by continued sales growth of the Company's proprietary travel vaccines and the launch-year sales of IXCHIQ®.Sales are expected to grow this year despite an estimated 20-30% reduction in third-party sales as a result of anticipated supply constraints.In 2024, the Company anticipates lower R&D expenses than previously communicated, narrowing guidance to €60 million to €75 million, based on additional visibility for its chikungunya- and Zika- related expenses. Additionally, Valneva expects non-dilutive contributions from institutions for R&D costs in connection with its ongoing chikungunya activities and the product tech transfers to Valneva's brand-new state-of the art facility (“Almeida”) in Scotland.
- 03/20/2024
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Valneva Announces Extension of the Interest-Only Period of Its Debt Facility with Deerfield and OrbiMed
- Saint-Herblain (France), March 18, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced an agreement with funds managed by leading U.S. healthcare investment firms Deerfield Management Company and OrbiMed to extend the interest-only period of its existing loan by eighteen months.
- 03/18/2024
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Valneva to Present at Upcoming TD Cowen and Van Lanschot Kempen Healthcare Investor Conferences
- Saint-Herblain (France), March 4, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that its senior management will participate at upcoming investor conferences in the United States and Europe. CEO Thomas Lingelbach will present Valneva at the TD Cowen 44th Annual Health Care Conference, taking place March 4 - 6, 2024, in Boston, MA. Mr. Lingelbach and CFO Peter Bühler will also meet with institutional investors during the Van Lanschot Kempen Life Sciences Conference, held April 16 - 17, 2024, in Amsterdam, The Netherlands.
- 03/04/2024
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U.S. CDC Advisory Committee (ACIP) Recommends Use of Valneva's Single-Dose Chikungunya Vaccine IXCHIQ®
- U.S. CDC Advisory Committee (ACIP) Recommends Use of Valneva's Single-Dose Chikungunya Vaccine IXCHIQ ®
- 02/29/2024
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Valneva Reports Full Year 2023 Revenue and Cash, Provides First 2024 Guidance
- Valneva Reports Full Year 2023 Revenue and Cash, Provides First 2024 Guidance Total revenues of €153.7 million, including product sales of €144.6 million Product sales surpassed pre-pandemic (2019) sales by 12% and 2022 sales by 26% Excluding COVID-19 vaccine sales, product sales grew by 63% compared to 2022 Cash position of €126.1 million at December 31, 2023 Excludes recent sale of the Priority Review Voucher (PRV) for $103 million (€95 million)1 Reflects significant payments related to the Phase 3 Lyme disease study, for which Valneva's cost contributions are expected to be completed in the first half 20242 First full year 2024 guidance Product sales expected between €150 million and €180 million, reflecting continued revenue growth for proprietary products and IXCHIQ®'s launch-year sales, despite anticipated supply constraints for third-party products and IXIARO® Other income anticipated between €95 million and €105 million, including the PRV sold in early 2024 for €95 million Expected R&D expenses between €65 million and €90 million Saint-Herblain (France), February 15, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) a specialty vaccine company, today reported its revenue and cash balance for the full year 2023 and provided first full year 2024 sales and R&D expense guidance. The Company will publish its 2023 audited consolidated financial statements on March 20, 2024.
- 02/15/2024
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Valneva sells chikungunya vaccine priority review voucher for $103 mln
- French vaccine maker Valneva said on Monday it sold the priority review voucher (PRV) it received from the U.S. Food and Drug Administration (FDA) for $103 million.
- 02/05/2024
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Valneva Announces Sale of Priority Review Voucher for $103 Million
- Saint-Herblain (France), February 5, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced it sold the Priority Review Voucher (PRV) it received from the U.S. Food and Drug Administration (FDA) for $103 million (€95 million).
- 02/05/2024
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Valneva Vaccinates First Participant in Pediatric Trial of Single-Shot Chikungunya Vaccine
- Saint-Herblain (France), January 10, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) today announced that the first participant has been vaccinated in the Phase 2 clinical trial evaluating the safety and Immunogenicity in children of two different dose levels of Valneva's single-shot chikungunya vaccine. The Company reported positive pivotal Phase 3 data in adolescents two months ago confirming the immunogenicity and safety profile observed in adults1.There is currently no approved chikungunya vaccine for children and Valneva's vaccine IXCHIQ® is currently the only licensed chikungunya vaccine2 to address this unmet medical need in adults aged 18 years and older who are at increased risk of exposure to the virus. Once available, the Phase 2 pediatric data are intended to support a Phase 3 pivotal study in children with the objective to extend the label in this age group following initial regulatory approvals in adults and possibly in adolescents.
- 01/10/2024
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Valneva to Conduct Investor Meetings during the J.P. Morgan Healthcare Conference and Oddo BHF Forum
- Saint-Herblain (France), January 4, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announces that members of its management team including Thomas Lingelbach, CEO and Peter Bühler, CFO will hold investor meetings during the 42nd Annual J.P. Morgan Healthcare Conference, January 8 – 10, 2024 in San Francisco and virtually at the Oddo BHF Forum on January 15,2024.
- 01/04/2024
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Valneva Provides Updated 2023 Financial Guidance
- Saint-Herblain (France), December 29, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the Company is modifying its financial guidance for 2023. Product sales guidance remains unchanged, as do anticipated R&D expenses. The €90 million to €110 million of other income related to proceeds from potential sale of the Company's priority review voucher (PRV), which was previously expected before year-end, is now expected in early 2024.
- 12/29/2023
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Valneva Shareholders Approve EGM Resolutions Including the Transition to a Board of Directors
- Anne-Marie Graffin is appointed as Chair of the Board of Directors Saint-Herblain (France), December 20, 2023 –Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that its shareholders approved the resolutions recommended by the Management Board at its Extraordinary General Meeting (EGM) held on December 20, 2023. These included the immediate transition from the Company's two-tier governance model to a one-tier model led by a Board of Directors.
- 12/20/2023
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Pfizer and Valneva Complete Recruitment for Phase 3 VALOR Trial for Lyme Disease Vaccine Candidate, VLA15
- Pfizer and Valneva Complete Recruitment for Phase 3 VALOR Trial for Lyme Disease Vaccine Candidate, VLA15 9,437* participants enrolled at sites across the U.S., Europe and Canada in areas where Lyme disease is endemic Trial conclusion expected by year-end 2025 Pfizer aims to submit regulatory filings in the U.S. and Europe in 2026 New York, NY, and Saint-Herblain (France), December 4, 2023 – Pfizer Inc. (NYSE: PFE) and Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) today announced that they have completed recruitment for the Phase 3 trial Vaccine Against Lyme for Outdoor Recreationists (VALOR) (NCT05477524) for Lyme disease vaccine candidate VLA15. The trial builds on previous positive Phase 1 and 2 trial results and includes both adult and pediatric participants, with the aim to confirm the efficacy, safety, lot consistency, and immunogenicity of VLA15.
- 12/04/2023
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Valneva Reports Positive 24-Month Antibody Persistence Data for its Single-Shot Chikungunya Vaccine IXCHIQ®
- Valneva Reports Positive 24-Month Antibody Persistence Data for its Single-Shot Chikungunya Vaccine IXCHIQ ®
- 12/04/2023
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Valneva says EU regulator accepts its chikungunya vaccine application
- French drugmaker Valneva said on Monday that the application for its vaccine candidate against mosquito-borne viral disease chikungunya was accepted by the European Medicines Agency (EMA) which would now examine the drug in a fast-track procedure.
- 11/27/2023
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FDA approves Valneva's Chikungunya vaccine for adults
- French drugmaker Valneva said on Friday the U.S. Food and Drug Administration (FDA) has approved its Chikungunya single-dose vaccine in individuals aged 18 and above.
- 11/10/2023
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US FDA approves Valneva's chikungunya vaccine
- The U.S. Food and Drug Administration (FDA) on Thursday approved Valneva's single-shot vaccine for individuals 18 years of age and older who are at increased risk of exposure to chikungunya virus.
- 11/09/2023
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Valneva to Present and Hold Investor Meetings at the Jefferies London Healthcare Conference
- Saint-Herblain (France), November 7, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that its senior management will present and participate in 1-on-1 meetings with institutional investors at the Jefferies London Healthcare Conference, to take place November 14-16, 2023 in London, UK.
- 11/07/2023
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Valneva to Present on Chikungunya at Several Leading Scientific Conferences
- Saint-Herblain (France), October 11, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, announces today it will present on the mosquito-borne chikungunya disease at several leading scientific conferences during the fourth quarter of 2023.
- 10/11/2023
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Valneva's Vaccination Valor: A Buy Rating Justified
- Valneva's 1H 2023 revenue declined compared to the previous year, but product sales more than doubled, driven by the recovery in the travel market. The phase 3 trial for VLA15, a Lyme disease vaccine candidate, is progressing well, with plans for official submissions to the FDA and EMA in 2026. Valneva's chikungunya vaccine, VLA1553, awaits PDUFA action by the end of November 2023, with the potential for a Priority Review Voucher valued at $100M.
- 10/04/2023
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Pfizer, Valneva announce 'positive' results for Lyme disease vaccine candidate booster shot
- Pfizer and French pharmaceutical peer Valneva announced on Thursday that a phase 2 study for its VLA15 Lyme disease vaccine candidate showed a "strong immune response" in both children and adolescents one month after receiving a booster shoot.
- 09/07/2023
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Valneva to Participate in Investor Conferences in the United States and Europe in September 2023
- Saint- Herb lain (France ) , August 31 , 2 02 3 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that members of its senior leadership team are scheduled to participate in 1-on-1 meetings with institutional investors at the following investor conferences in September 2023.
- 08/31/2023
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7 Unmatched Stocks: The Untapped Goldmines to Buy Now.
- While many financial advisors will direct you to established public enterprises, investors seeking some “oomph” for their portfolio may want to target “unmatched” stocks with potential. Rather than walking along the beaten path, these lesser-known entities carry significantly higher risk.
- 08/24/2023
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Valneva: VLA1553 Takes The Lead In The Chikungunya Vaccine Race
- Positive Phase 3 data from Bavarian Nordic's chikungunya virus (CHIKV) vaccine candidate, PXVX0317, reinforces bullish view on Valneva's VLA1553 due to its superior clinical profile. Valneva's VLA1553 demonstrated impressive seroresponse rates and durability, with future data releases from Bavarian Nordic's additional Phase 3 trial expected to provide a comprehensive comparison between the two vaccines. Valneva has submitted a regulatory application to Health Canada for VLA1553 approval and received Fast Track.
- 07/18/2023
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Strength Seen in Valneva SE Sponsored ADR (VALN): Can Its 15.8% Jump Turn into More Strength?
- Valneva SE Sponsored ADR (VALN) was a big mover last session on higher-than-average trading volume. The latest trend in earnings estimate revisions might not help the stock continue moving higher in the near term.
- 06/21/2023
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Valneva to Present and Hold Investor Meetings at Upcoming Conferences in June
- Saint- Herb lain (France) , May 31 , 2 02 3 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that its senior management will attend the Jefferies Healthcare Conference (June 7-9 in New York), Goldman Sachs Annual Global Healthcare Conference (June 12-15 in Dana Point, California) and the Stifel European Healthcare Conference (June 28-30 in Bordeaux, France).
- 05/31/2023
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Valneva (VALN) Stock Down 53% in the Past Year: Here's Why
- The European Commission's revised advance purchase agreement jeopardizes Valneva's (VALN) COVID-19 vaccine program.
- 05/30/2023
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Valneva SE (VALN) Q1 2023 Earnings Call Transcript
- Valneva SE (NASDAQ:VALN ) Q1 2023 Earnings Conference Call May 4, 2023 9:00 AM ET Company Participants Joshua Drumm - VP, IR Thomas Lingelbach - Chairman, President & CEO Peter Buhler - CFO Conference Call Participants Kevin Strang - Jefferies Edward White - H.C. Wainwright & Co Boran Wang - Guggenheim Securities Simon Scholes - First Berlin Rajan Sharma - Goldman Sachs Group Samir Devani - Rx Securities Limited Max Herrmann - Stifel, Nicolaus & Company Operator Good day and thank you for standing by.
- 05/06/2023
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Valneva to Present on its Chikungunya Vaccine Candidate and Host a Roundtable at the 23rd World Vaccine Congress in Washington D.C.
- Saint Herblain (France), March 30, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, announced today it will present on its single-shot chikungunya vaccine candidate, VLA1553, and host a roundtable on Zika vaccines next week at the 23rd World Vaccine Congress in Washington, D.C.
- 03/30/2023
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Valneva Q4: Resilient Pipeline And Partnership With Pfizer, Reinforcing A Promising Future
- Valneva's pipeline and high-stakes clinical catalysts warrant a buy rating, despite the setback in its Lyme disease Phase 3 trial. The CHIKV vaccine candidate is on track for PDUFA in August 2023, and the company plans to launch one or two programs in clinical trials by the close of 2023.
- 03/29/2023
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Valneva SE (VALN) Q4 2022 Earnings Call Transcript
- Valneva SE (NASDAQ:VALN ) Q4 2022 Earnings Conference Call March 23, 2023 10:00 AM ET Company Participants Joshua Drumm - Vice President of Investor Relations Thomas Lingelbach - Chief Executive Officer Peter Buhler - Chief Financial Officer Conference Call Participants Maury Raycroft - Jefferies Evan Wang - Guggenheim Securities Max Herrmann - Stifel Nicolaus Rajan Sharma - Goldman Sachs Samir Devani - Rx Securities Operator 0Good day, and thank you for standing by. Welcome to the Valneva Full-Year 2022 Financial Results Conference Call.
- 03/23/2023
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Valneva to Present at the Cowen 43rd Annual Healthcare Conference
- Saint- Herb lain (France) , March 1 , 2 02 3 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that its senior management will present and participate in 1-on-1 meetings with institutional investors at the Cowen 43rd Annual Healthcare Conference, to take place in-person March 6 - 8, 2023 in Boston, Massachusetts.
- 03/01/2023
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Valneva SE: Underfollowed French Biotech, 2 Interesting Vaccine Approvals Expected In 2023
- Valneva SE is a French biotechnology company specializing in developing and commercializing vaccines. We expect approval of two attractive vaccine candidates targeting Chikungunya and Lyme disease by 2024-2025.
- 02/26/2023
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Valneva (VALN) Stock Down 61.5% in the Past Year: Here's Why
- Valneva's (VALN) COVID-19 vaccine looks promising, but the European Commission's revised advance purchase agreement jeopardizes its COVID-19 vaccine program.
- 01/16/2023
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What Makes Valneva SE Sponsored ADR (VALN) a New Buy Stock
- Valneva SE Sponsored ADR (VALN) might move higher on growing optimism about its earnings prospects, which is reflected by its upgrade to a Zacks Rank #2 (Buy).
- 01/03/2023
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Valneva (VALN) Up on Antibody Persistence Data on Chikungunya Jab
- Valneva (VALN) posts encouraging 12-month antibody persistence data for its single-shot chikungunya vaccine candidate, VLA1553. Shares rise.
- 12/06/2022
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Valneva (VALN) Up on 6-Month Lyme Disease Jab Persistence Data
- Persistence data from a mid-stage study showed that Valneva's (VALN) Lyme disease vaccine elicited antibody levels which remained above baseline six months after completing dose administration in children and adults.
- 12/02/2022
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Will A Pfizer-Partnered Vaccine Help Valneva Stock Buck Its Recent Downtrend?
- Valneva stock rose Thursday after it said volunteers who received its Pfizer-partnered Lyme disease shot still had antibodies after six months. The post Will A Pfizer-Partnered Vaccine Help Valneva Stock Buck Its Recent Downtrend?
- 12/01/2022
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Valneva SE (VALN) Q3 2022 Earnings Call Transcript
- Valneva SE (NASDAQ:VALN ) Q3 2022 Earnings Conference Call November 10, 2022 9:00 AM ET Company Participants Thomas Lingelbach – President and Chief Executive Officer Peter Buhler – Chief Financial Officer Conference Call Participants Maury Raycroft – Jefferies Samir Devani – Rx Securities Evan Wang – Guggenheim Partners Max Herrmann – Stifel Arsene Guekam – Kepler Cheuvreux Olga Smolentseva – Bryan Garnier Nick Hallatt – Goldman Sachs Operator Good day, and thank you for standing by. Welcome to the Valneva Reports Nine-Month 2022 Results and Provides Corporate Updates Call.
- 11/10/2022
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Valneva to Present and Hold Investor Meetings at the Jefferies London Healthcare Conference
- Saint- Herb lain (France) , November 7 , 2 02 2 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that its Chief Executive Officer Thomas Lingelbach and Chief Financial Officer Peter Bühler will present and participate in 1-on-1 meetings with institutional investors at the Jefferies London Healthcare Conference, to take place November 15-17, 2022 in London, England.
- 11/07/2022
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All You Need to Know About Valneva SE Sponsored ADR (VALN) Rating Upgrade to Buy
- Valneva SE Sponsored ADR (VALN) has been upgraded to a Zacks Rank #2 (Buy), reflecting growing optimism about the company's earnings prospects. This might drive the stock higher in the near term.
- 10/12/2022
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Valneva to Present on its Single-Shot Chikungunya Vaccine Candidate at Leading Scientific Conferences
- Saint- Herb lain (France ) , October 10 , 2 02 2 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, announces today it will present on its single-shot chikungunya vaccine candidate at several leading scientific conferences during the fourth quarter of 2022.
- 10/10/2022
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7 Vaccine Stocks to Sell ASAP Now That the ‘Pandemic's Over'
- As people acclimatize to the new normal, it's time to look at some vaccine stocks to sell. Instead of relying primarily on vaccines and antiviral drugs, the government let people manage infections.
- 09/27/2022
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Valneva (VALN) Stock Down 66% in the Past 6 Months: Here's Why
- Valneva's (VALN) COVID-19 vaccine looks promising, but the European Commission's revised advance purchase agreement jeopardizes its COVID-19 vaccine program.
- 09/26/2022
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Valneva cuts full-year outlook on lower COVID-19 vaccine sales
- Vaccine developer Valneva on Thursday cut its full-year revenue outlook to account for lower orders of its COVID-19 vaccine after both the European Union and the UK walked away from supply contracts worth more than $1 billion combined.
- 08/11/2022
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Pfizer, Valneva begin major test of first possible Lyme vaccine in 20 years
- DUNCANSVILLE, Pa. — Researchers are seeking thousands of volunteers in the U.S. and Europe to test the first potential vaccine against Lyme disease in 20 years — in hopes of better fighting the tick-borne threat.
- 08/08/2022
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Valneva: Vaccine Business, Catalysts Ahead, And Pfizer's Lyme Love
- Valneva is a specialty vaccines company with an ongoing travelers vaccine business. Two major catalysts are around the corner: a BLA for chikungunya vaccine and a Phase 3 trial for the world's only Lyme vaccine candidate.
- 08/08/2022
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This Biotech Company Is Soaring; Do Not Be Left Out.
- Valneva (NASDAQ: VALN) has had a good run this week. It soared 49% at the beginning of trading day Monday and has continued its positive ride.
- 06/25/2022
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Valneva SE Sponsored ADR (VALN) Stock Jumps 93.1%: Will It Continue to Soar?
- Valneva SE Sponsored ADR (VALN) saw its shares surge in the last session with trading volume being higher than average. The latest trend in earnings estimate revisions may not translate into further price increase in the near term.
- 06/22/2022
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Valneva (VALN) Stock: Why It Skyrocketed 93.14% Today
- The stock price of Valneva SE (NASDAQ: VALN) surged by 93.14% today. This is why.
- 06/21/2022
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Why Shares Of Valneva SE Are Soaring Today
- Valneva SE (NASDAQ: VALN) shares are trading higher after the company and Pfizer announced they have entered into an Equity Subscription Agreement and have updated the terms of their Collaboration and License Agreement for Lyme disease vaccine candidate VLA15. As part of the Equity Subscription.
- 06/21/2022
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This biotech stock is up 100% on Tuesday: here's the catalyst
- Pfizer Inc (NYSE: PFE), on Tuesday, doubled down on its partnership with Valneva SE (NASDAQ: VALN) to develop a vaccine for Lyme disease. Shares of the French biotech firm are up nearly 100% this morning.
- 06/21/2022
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Why Is Valneva (VALN) Stock Up 85% Today?
- Valneva (VALN) stock is rocketing higher on Tuesday following news that Pfizer (PFE) is taking a stake in the vaccine company. The post Why Is Valneva (VALN) Stock Up 85% Today?
- 06/21/2022
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The Shopify Split Is Just Days Away, but This Tiny Nasdaq Stock Is Soaring Right Now
- Markets looked poised for a rebound on Tuesday.
- 06/21/2022
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Pfizer makes equity investment in Valneva as they prepare for Phase 3 trial of Lyme disease vaccine candidate
- U.S.-listed shares of Valneva VALN, -13.47% soared 81.9% in premarket trading on Tuesday, the day after Pfizer Inc. PFE, -2.00% announced a $95 million equity investment in Valneva as part of a previously established agreement aimed at developing a Lyme disease vaccine. The investment is expected to support the Phase 3 clinical trials for the Lyme disease vaccine candidate, which are set to begin in the third quarter of this year.
- 06/21/2022
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Why Are Valneva Shares Rallying Today
- Pfizer Inc (NYSE: PFE) will invest €90.5 million ($95 million) for an 8.1% stake in Valneva SE (NASDAQ: VALN), as the companies updated the terms of agreement for Lyme disease vaccine candidate VLA15. Pfizer will buy the stake in Valneva at €9.49/share via a.
- 06/21/2022
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Pfizer to buy 8.1% of capital of vaccines company Valneva
- French specialty vaccine company Valneva and U.S. healthcare giant Pfizer said they had entered an equity subscription agreement under which Pfizer will invest 90.5 million euros ($95.24 million) in Valneva, representing 8.1% of its capital.
- 06/20/2022
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Valneva (VALN) Stock Declines 59% in 3 Months: Here's Why
- Though Valneva's (VALN) COVID-19 vaccine looks promising, the European Commission's intent to terminate the advance purchase agreement for the vaccine puts the future of the company's COVID-19 vaccine program into jeopardy.
- 06/17/2022
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Valneva (VALN) Down on its COVID-19 Vaccine Update in Europe
- Valneva (VALN) slides on a proposed remediation plan update after receiving the European Commission's notice of intent to terminate the Advance Purchase Agreement for its COVID-19 vaccine.
- 06/14/2022
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Valneva's stock slides after saying Europe may not order the company's COVID-19 vaccine candidate
- Shares of Valneva SE VALN, -14.89% fell 13.3% in premarket trading on Monday after the company said it proposed a remediation plan to the European Commission after learning of plans to terminate the purchase agreement for Valneva's COVID-19 vaccine candidate. If the agreement reduces the total amount of vaccine in the order, that will impact the sustainability of the company's vaccine program, the company said.
- 06/13/2022
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Valneva Says Working On Remediation Plan For Investigational COVID-19 Vaccine
- Valneva SE (NASDAQ: VALN) proposed a remediation plan after receiving the European Commission's notice of intent to terminate the advance purchase agreement for its inactivated COVID-19 vaccine candidate. "Some member states have confirmed their interest in having an.
- 06/13/2022
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Valneva to Present on its Single-Shot Chikungunya Vaccine Candidate, Host Symposium at NECTM8
- Saint - Herblain ( France), June 7 , 20 22 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, announced today it will present on its single-shot chikungunya vaccine candidate VLA1553 on June 9, 2022 at the 8th Northern European Conference on Travel Medicine (NECTM8) in Rotterdam.
- 06/07/2022
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Valneva to Present and Hold Investor Meetings at the Jefferies US Healthcare Conference
- Saint- Herb lain (France) , June 3 , 2 02 2 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that its senior management will present and participate in 1-on-1 meetings with institutional investors at the Jefferies Healthcare Conference which will take place from June 8 to 10, 2022 in New York.
- 06/03/2022
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Valneva says the European Medicines Agency accepted application for its COVID-19 vaccine
- U.S.-listed shares of Valneva SE VALN, -3.09% VLA, +10.48% jumped 11.5% in premarket trading on Thursday after the company said that the European Medicines Agency has accepted the application of its COVID-19 vaccine candidate. If the experimental shot receives a positive recommendation from the EMA's Committee for Human Medicinal Products, the company said it expects a decision in June.
- 05/19/2022
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Valneva (VALN) Down as EU Considers Ending COVID-Vaccine Deal
- Per the agreement with the European Commission, Valneva (VALN) has 30 days from May 13, 2022 to win a marketing authorization in the EU for its COVID vaccine or offer an acceptable remediation plan.
- 05/17/2022
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EU Says Final Decision Yet To Be Taken On Terminating Valneva COVID-19 Vaccine Deal
- The European Commission said that no final decision had been made about the possible termination of a contract with Valneva SE (NASDAQ: VALN) to supply its COVID-19 vaccine to the European Union. Earlier today, Valneva said it received a notice of intent from the Commission to.
- 05/16/2022
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Valneva shares slump after COVID vaccine deal with EU falls apart
- (Reuters) -Valneva lost nearly a fifth of its value on Monday after the French drugmaker said its COVID-19 vaccine agreement with the European Commission was likely to be scrapped and it might have to rethink its financial guidance.
- 05/16/2022
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Valneva SE (VALN) CEO Thomas Lingelbach on Q1 2022 Results - Earnings Call Transcript
- Valneva SE (NASDAQ:VALN ) Q1 2022 Earnings Conference Call May 5, 2022 10:00 AM ET Company Participants Thomas Lingelbach - Chief Executive Officer Peter Buhler - Chief Financial Officer Franck Grimaud - Chief Business Officer Conference Call Participants Samir Devani - Rx Securities Maury Raycroft - Jefferies Max Herrmann - Stifel Financial Corp. Evan Wang - Guggenheim Securities Jean-Jacques Le Fur - Bryan Garnier Franck Grimaud - Chief Business Officer Sebastiaan van der Schoot - Kempen & Company Thomas Lingelbach Good day, and welcome to our quarter one Financial Results and Corporate Update Call. Pleasure to be with you again today.
- 05/09/2022
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Valneva Shares Jump As Its COVID-19 Vaccine Receives Conditional Approved In UK
- The Healthcare products Regulatory Agency (MHRA) of the U.K. has granted Conditional Marketing Authorization for Valneva SE's (NASDAQ: VALN)COVID-19 vaccine candidate, VLA2001, for primary immunization in adults 18 to 50 years of age. MHRA found that VLA2001 meets safety,.
- 04/14/2022
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5 Top Health Care Stocks To Watch In The Stock Market Today
- Are these health care stocks on your watchlist right now?
- 04/03/2022
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Valneva SE (VALN) CEO Thomas Lingelbach on Q4 2021 Results - Earnings Call Transcript
- Valneva SE (VALN) CEO Thomas Lingelbach on Q4 2021 Results - Earnings Call Transcript
- 03/24/2022
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Good Stocks To Buy Right Now? 4 Health Care Stocks For Your List
- Could health care stocks be the top picks in the stock market this week?
- 03/15/2022
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Valneva (VALN) Completes Phase III Chikungunya Vaccine Study
- Valneva's (VALN) phase III study evaluating its chikungunya vaccine achieves all primary and secondary endpoints. The stock rises 9.2% following the announcement.
- 03/09/2022
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Top Biotech Stocks To Buy Now? 5 For Your Late January Watchlist
- Which biotech stocks are you watching today?
- 01/20/2022
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Valneva (VALN) Up as COVID-19 Jab Neutralizes Omicron Variant
- Three doses of Valneva's (VALN) inactivated COVID-19 vaccine candidate, VLA2001, neutralizes the Omicron variant of SARS-CoV-2, per data from preliminary lab studies. Shares rally.
- 01/20/2022
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VALN Stock Alert: 4 Things to Know About the Vaccine News Sending Valneva Soaring
- Valneva is picking up attention as the biotech firm is up more than 30% today. Will its vaccine candidate power VALN stock to new highs?
- 01/19/2022
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Why Valneva Shares Are Soaring Today
- Valneva SE (NASDAQ: VALN) is trading significantly higher Wednesday following results from an initial laboratory study, which demonstrated that serum antibodies induced by three doses of Valneva's COVID-19 vaccine candidate, VLA2001, neutralize the omicron variant. Samples from 30 participants in the Phase 1/2 trial of Valneva's COVID-19 candidate were used in a pseudovirus assay to analyze neutralization of the ancestral SARS-CoV-2 virus as well as the delta and omicron variants.
- 01/19/2022
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Shares in COVID-19 vaccine developer Valneva extend fall
- Shares in biotech company Valneva fell again on Wednesday, declining for the seventh day in a row due to a growing belief amongst investors that the COVID-19 Omicron variant might lessen the need for mass vaccination.
- 01/05/2022
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Is This New Data on Valneva's Less-Effective Booster Concerning?
- Some recent dismal results for Valneva's vaccine looked bad. But there could be more to the story.
- 12/18/2021
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5 Biotech Stocks For Your Late December 2021 Watchlist
- Should investors be treating these top biotech stocks as top picks in the stock market now?
- 12/16/2021
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Valneva's stock is up 14% after the company shares promising data for its COVID-19 booster candidate
- U.S.-listed shares of Valneva SE VALN, +12.95% were up 14.9% in trading on Thursday after the company said in a news release that its experimental COVID-19 booster shot boosted antibody levels in people who were already vaccinated with Valneva's primary series of shots. The Phase 1/2 study assessed antibody levels between seven to eight months after participants had been fully vaccinated with the company's shots, which are still considered investigational.
- 12/16/2021
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Valneva's COVID-19 Shot Fails As Booster In Pfizer/BioNTech Vaccinated Population
- Valneva SE (NASDAQ: VALN) has responded to data published from the U.K COV-Boost COVID-19 vaccine trial that investigated the reactogenicity and immunogenicity of seven different COVID-19 vaccines at different dose levels in vaccinated individuals. All seven vaccines given in the COV-Boost study increased immunity when given as booster shots to people who had previously received two doses of AstraZeneca Plc's (NASDAQ: AZN) Vaxzevria.
- 12/03/2021
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4 Top Biotech Stocks To Watch Now
- With all eyes on the pandemic once again, these biotech players could be gaining more exposure.
- 11/29/2021
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Valneva Recruits IDT Biologika As Manufacturing Partner For Its COVID-19 Vaccine
- Valneva SE (NASDAQ: VALN) and IDT Biologika have announced their collaboration to produce Valneva's inactivated COVID-19 vaccine candidate VLA2001. It follows last week's announcement that Valneva signed an Advance Purchase Agreement with the European Commission to supply up to 60 million doses of VLA2001 over two years.
- 11/29/2021
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Valneva SE (VALN) Stock: Why The Price Increased Today
- The stock price of Valneva SE (NASDAQ: VALN) increased by over 17% pre-market. This is why it happened.
- 11/26/2021
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Why Are Valneva Shares Trading Higher Today?
- Valneva SE (NASDAQ: VALN) has signed an Advance Purchase Agreement (APA) with the European Commission (EC) to supply up to 60 million doses of its inactivated COVID-19 vaccine candidate VLA2001, over two years. The agreement follows the announcement made earlier this month that the EC had approved the APA.
- 11/23/2021
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Valneva to Present its Chikungunya Vaccine Candidate at the ASTMH 2021 Annual Meeting
- Saint - Herblain ( France), November 15 , 2021 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced it will present its Chikungunya vaccine candidate, VLA1553, on November 18 and 19, 2021 during the American Society of Tropical Medicine & Hygiene (ASTMH) 2021 Annual Meeting.
- 11/15/2021
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Valneva (VALN) Stock Rises on Deal With EU for COVID-19 Jab
- Valneva (VALN) enters into a supply agreement for its COVID vaccine candidate with the European Commission. The stock price surges following the news.
- 11/11/2021
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Valneva to Present and Hold Investor Meetings at the Jefferies London Healthcare Conference
- Saint- Herb lain (France) , November 8 , 2 021 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that its senior management will present and participate in 1-on-1 meetings with institutional investors at the Jefferies London Healthcare Conference on November 16 and 17, 2021.
- 11/08/2021
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These 2 Nasdaq Biotechs Are Making Huge Premarket Moves Monday
- The Nasdaq looks poised to open slightly lower after a strong week.
- 10/18/2021
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Why Are Valneva's Shares Trading Higher Monday Premarket?
- Valneva SE's (NASDAQ: VALN) COVID-19 vaccine elicits a robust immune response with far fewer side effects than the Oxford/AstraZeneca plc's (NASDAQ: AZN) jab, according to Phase 3 trial results. Valneva said its latest trial, Cov-Compare, included around 4,000 participants aged 18 and older across 26 trial sites.
- 10/18/2021
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Valneva Reports Positive Phase 3 Results for Inactivated, Adjuvanted COVID-19 Vaccine Candidate VLA2001
- Saint Herblain ( France), October 18 , 2021 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced positive topline results from the Phase 3 pivotal trial Cov-Compare of its inactivated, adjuvanted COVID-19 vaccine candidate, VLA2001. Valneva's Chief Executive Officer, Thomas Lingelbach, and the trial's Chief Investigator, Adam Finn, Professor of Paediatrics at the University of Bristol, will comment on the results in a live webcast beginning at 3 p.m. CET today. Please refer to this link: https://edge.media-server.com/mmc/p/3zmb7nnp.
- 10/18/2021
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Valneva Announces the Cancellation of Ordinary Shares Held by the Company following Termination of its Liquidity Agreement
- Saint- Herb lain (France) , October 4 , 2021 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the Management Board has decided, during a meeting today, to cancel all ordinary shares held by the Company following the termination of its liquidity agreement with Oddo BHF on June 11, 2021 (i.e., 4,025 ordinary shares in total, representing 0.004% of the share capital).
- 10/04/2021
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Valneva Continues To Expand COVID-19 Vaccine Candidate Trials
- Valneva SE (NASDAQ: VALN) has commenced recruitment of adolescents in its pivotal Phase 3 trial for its inactivated COVID-19 vaccine candidate VLA2001 in the U.K. Topline results from the trial, dubbed Cov-Compare, are expected early in Q4 of 2021 and are intended to form the basis for potential regulatory approval in adults.
- 09/23/2021
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Valneva Continues Expansion of Clinical Trials of its Inactivated COVID-19 Vaccine Candidate VLA2001
- Saint- Herb lain (France ) , September 23 , 2021 – Valneva SE, (Nasdaq: VALN; Euronext Paris: VLA) a specialty vaccine company, today announced that it has commenced recruitment of adolescents in its pivotal Phase 3 Clinical Trial (VLA2001-301, “Cov-Compare”) for its inactivated COVID-19 vaccine candidate VLA2001 in the United Kingdom. Topline results from the pivotal Cov-Compare trial are expected early in the fourth quarter of 2021 and are intended to form the basis for potential regulatory approval in adults. The Company has also started to provide boosters to volunteers in its Phase 1/2 VLA2001-201 trial. This planned expansion of VLA2001 clinical trials will support future approval in further age groups, in addition to adults.
- 09/23/2021
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SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Valneva SE - VALN
- New York, New York--(Newsfile Corp. - September 21, 2021) - Pomerantz LLP is investigating claims on behalf of investors of Valneva SE ("Valneva" or the "Company") (NASDAQ: VALN). Such investors are advised to contact Robert S. Willoughby at newaction@pomlaw.com or 888-476-6529, ext. 7980.The investigation concerns whether Valneva and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices. [Click here for information about...
- 09/21/2021
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SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Valneva SE - VALN
- NEW YORK, Sept. 19, 2021 /PRNewswire/ -- Pomerantz LLP is investigating claims on behalf of investors of Valneva SE ("Valneva" or the "Company") (NASDAQ: VALN).
- 09/19/2021
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SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Valneva SE - VALN
- NEW YORK, Sept. 13, 2021 /PRNewswire/ -- Pomerantz LLP is investigating claims on behalf of investors of Valneva SE ("Valneva" or the "Company") (NASDAQ: VALN).
- 09/13/2021
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VALN Stock: Why It Significantly Decreased Today
- The stock price of Valneva SE (NASDAQ: VALN) fell by over 35% pre-market today. This is why it happened.
- 09/13/2021
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China Crackdown Continues
- Chinese regulators continue to apply pressure on the country's biggest tech companies, this time reportedly looking to split up Alibaba (NYSE:BABA) founder Jack Ma's Alipay. Beijing is pushing for Alipay to create a separate app for its loan business.
- 09/13/2021
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VALN Stock: Over 12% Increase Pre-Market Explanation
- The stock price of Valneva SE (NASDAQ: VALN) increased by over 12% pre-market. This is why it happened.
- 09/07/2021
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Valneva: U.S. DoD Exercises First Year Option on IXIARO® Supply Contract
- Saint Herblain ( France), September 3 , 2021 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) a specialty vaccine company, today announced that the U.S. Department of Defense (DoD) has exercised the first option of the contract signed in September 20201 to purchase further supply of its Japanese encephalitis (JE) vaccine IXIARO®.
- 09/03/2021
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Valneva (VALN) Begins Submission for COVID-19 Vaccine in UK
- Valneva (VALN) starts rolling submission for the initial approval of its COVID-19 vaccine candidate, VLA2001, in the United Kingdom.
- 08/23/2021
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Valneva Reports H1 2021 Financial Results and Provides Business Update
- Key R&D Milestones Achieved
- 08/10/2021
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Valneva Announces Positive Phase 3 Pivotal Results for its Single-Shot Chikungunya Vaccine Candidate
- Saint Herblain ( France), August 5 , 2021 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need, today announced positive topline results from the Phase 3 pivotal trial of its single-shot chikungunya vaccine candidate, VLA1553. VLA1553 was recently awarded Breakthrough Designation status by the Food and Drug Administration (FDA).
- 08/05/2021
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Valneva Appoints Peter Buhler as Chief Financial Officer
- Saint- Herblain (France), July 29 , 2021 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need, today announced the appointment of Peter Buhler as Chief Financial Officer (CFO) and Management Board member.
- 07/29/2021
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7 Stocks to Buy if the Third Covid Wave Intensifies
- Stocks to buy as the third Covid-19 wave intensifies with the delta variant being dominant globally. Stocks for healthy near-term returns.
- 07/15/2021
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Valneva's Chikungunya Vaccine Candidate Gets FDA Breakthrough Tag
- The FDA grants Breakthrough Therapy Designation to Valneva SE's (NASDAQ: VALN) single-shot chikungunya vaccine candidate, VLA1553. This new U.S. milestone comes in addition to the FDA Fast Track designation and the European Medicines Agency's PRIME designation, which the Company received in December 2018 and in October 2020, respectively.
- 07/07/2021
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Valneva Strengthens Management Team; Appoints Vincent Dequenne as SVP Operations and Joshua Drumm as VP Investor Relations
- Saint- Herblain (France), July 6 , 2021 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need, announced today it has appointed Vincent Dequenne as Senior Vice President Operations and Joshua Drumm as Vice President Investor Relations.
- 07/06/2021
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Valneva Continues Ongoing Discussions with the European Commission for Inactivated COVID-19 Vaccine Candidate
- Saint- Herblain (France), July 1 , 2021 – Following a media article published yesterday, Valneva SE, (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need, indicated today it continues ongoing discussions with the European Commission regarding VLA2001, Valneva's inactivated COVID-19 vaccine candidate.
- 07/01/2021
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Valneva Announces Successful Outcome of its AGM
- Saint - Herblain ( France), June 23 , 2021 – Valneva S E (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need, announced today that all the resolutions recommended by the Management Board were approved by the shareholders at its Annual General Meeting (AGM) held as a closed session at its registered office on June 23, 2021.
- 06/23/2021
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7 Best Vaccine Stocks for Their Pipeline Potential
- These Covid-19 vaccine stocks may be late in the race, but they certainly have growth potential as we head into the summer. The post 7 Best Vaccine Stocks for Their Pipeline Potential appeared first on InvestorPlace.
- 06/03/2021
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