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Avenue Therapeutics Announces Last Patient Last Visit in Phase 1b/2a Clinical Trial of AJ201 for the Treatment of Spinal and Bulbar Muscular Atrophy (Kennedy's Disease)

  • Topline results of the Phase 1b/2a clinical trial anticipated mid-year 2024 Topline results of the Phase 1b/2a clinical trial anticipated mid-year 2024
    05/16/2024

Avenue Therapeutics Reports First Quarter 2024 Financial Results and Recent Corporate Highlights

  • – Raised a total of $9.4 million in gross proceeds from warrant exercise transactions since January 2024 – MIAMI, May 15, 2024 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases, today reported financial results and recent corporate highlights for the first quarter ended March 31, 2024. “The first quarter was incredibly productive for Avenue, as we've successfully executed on key milestones across our pipeline of CNS treatments,” said Alexandra MacLean, M.D.
    05/15/2024
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The price of Avenue Therapeutics, Inc. (ATXI) is 3.73 and it was updated on 2024-05-18 01:21:18.

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Avenue Therapeutics Announces Exercise of Warrants for $4.4 Million in Gross Proceeds

  • MIAMI, April 29, 2024 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases, today announced the entry into definitive agreements for the immediate exercise of certain outstanding warrants to purchase an aggregate of 689,680 shares of the Company's common stock. The exercised warrants are comprised of warrants to purchase shares of common stock originally issued by Avenue on October 11, 2022, each having an exercise price of $116.25 per share, Series A and Series B warrants to purchase shares of common stock originally issued by Avenue on November 2, 2023, each having an exercise price of $22.545 per share, and warrants to purchase shares of common stock originally issued by Avenue on January 9, 2024, each having an exercise price of $22.545 per share. The warrant holders agreed to exercise these warrants for cash at a reduced exercise price of $6.20 per share. The shares of common stock issuable upon exercise of the warrants are registered pursuant to effective registration statements on Form S-1 (File Nos. 333-267206 and 333-274562) and Form S-3 (No. 333-276671). The gross proceeds to Avenue from the exercise of the warrants are expected to be approximately $4.4 million, prior to deducting placement agent fees and offering expenses. The closing of the warrant exercise transaction is expected to occur on or about May 1, 2024, subject to satisfaction of customary closing conditions.
    Mon, Apr. 29, 2024

Avenue Therapeutics Announces Reverse Stock Split

  • MIAMI, April 24, 2024 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases, today announced that it will effect a 1-for-75 reverse split of its issued and outstanding common stock. Avenue expects its common stock to begin trading on a split-adjusted basis on the Nasdaq Capital Market as of the commencement of trading on April 26, 2024 with a new CUSIP number of 05360L403. The ticker symbol for the Company's stock will remain “ATXI.”
    Wed, Apr. 24, 2024

Avenue Therapeutics to Host Virtual Key Opinion Leader (KOL) Event on April 4, 2024

  • MIAMI, March 25, 2024 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases, today announced that it will host a virtual key opinion leader (“KOL”) event highlighting expert perspectives on spinal bulbar muscular atrophy (“SBMA”), also known as Kennedy's Disease, on Thursday, April 4, 2024 at 11:00am ET.
    Mon, Mar. 25, 2024

Avenue Therapeutics Reports Full Year 2023 Financial Results and Recent Corporate Highlights

  • - Enrollment completed in Phase 1b/2a clinical trial of AJ201 for spinal and bulbar muscular atrophy; topline data expected in second quarter of 2024 -
    Mon, Mar. 18, 2024

Avenue Therapeutics Receives Positive Listing Determination from Nasdaq

  • MIAMI, March 15, 2024 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases, today announced that by decision dated March 11, 2024, the Nasdaq Hearings Panel granted the Company's request for an extension to evidence compliance with all applicable criteria for continued listing on The Nasdaq Capital Market, including the $1.00 bid price and $2.5 million stockholders' equity requirements, through May 20, 2024. The Company is considering all available options that may enable it to timely evidence compliance with the continued listing criteria and maintain its listing on Nasdaq; however, there can be no assurance that the Company will be able to do so.
    Fri, Mar. 15, 2024
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Avenue Therapeutics to Present BAER-101 Preclinical Data at American Society for Experimental Neurotherapeutics (ASENT) 2024 Annual Meeting

  • BAER-101 demonstrated full suppression of seizure activity in SynapCell's GAERS model of absence epilepsy, a proven indicator of efficacy in anti-seizure drug development with high predictability of response in humans
  • 03/11/2024

Avenue Therapeutics Announces Publication in Drug Development Research Highlighting First-In-Class Preclinical Data of BAER-101 in a Translational Model of Absence Epilepsy

  • -In vivo data supports BAER-101's unique ability to significantly suppress seizures using the SynapCell's Genetic Absence Epilepsy Rat from Strasbourg (“GAERS”) model of absence epilepsy- -In vivo data supports BAER-101's unique ability to significantly suppress seizures using the SynapCell's Genetic Absence Epilepsy Rat from Strasbourg (“GAERS”) model of absence epilepsy-
  • 02/22/2024

Avenue Therapeutics to Present at Sidoti January Micro-Cap Investor Conference

  • MIAMI, Jan. 11, 2024 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases, today announced that Alexandra MacLean, M.D., Chief Executive Officer, will present a corporate update at the Sidoti January Micro-Cap Investor Conference on Thursday, January 18, 2024 at 10:00 a.m. EST.
  • 01/11/2024

Avenue Therapeutics Enters into Warrant Exercise Transactions for $5.0 Million in Proceeds

  • MIAMI, Jan. 05, 2024 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases, today announced the entry into warrant exercise agreements with existing accredited investors for the immediate exercise of certain outstanding warrants to purchase an aggregate of 16.5 million shares of the Company's common stock. These warrants for immediate exercise include: (i) November 2023 Series B warrants to purchase an aggregate of 14.6 million shares of common stock issued by Avenue on November 2, 2023, each having an exercise price of $0.3006 per share, and (ii) January 2023 warrants to purchase an aggregate of 1.9 million shares of common stock issued by Avenue on January 31, 2023, each having an exercise price of $1.55 per share, at a reduced exercise price of $0.3006 per share as agreed upon by the Company. The gross proceeds to Avenue from the exercise of the warrants are expected to be approximately $5.0 million, prior to deducting placement agent fees and estimated offering expenses. The closing of the warrant exercise transactions is expected to occur on or about January 9, 2024, subject to satisfaction of customary closing conditions.
  • 01/05/2024

Avenue Therapeutics Reaches Final Agreement with the U.S. FDA for the Phase 3 Safety Study for IV Tramadol

  • MIAMI, Jan. 04, 2024 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases, today announced that it has reached final agreement with the U.S. Food and Drug Administration (“FDA”) on the Phase 3 safety study protocol and statistical analysis approach, including the primary endpoint, for intravenous (IV) tramadol, which is in development for the treatment of acute post-operative pain in a medically supervised setting. The final non-inferiority study is designed to assess the theoretical risk of opioid-induced respiratory depression related to opioid stacking on IV tramadol compared to IV morphine.
  • 01/04/2024

Avenue Therapeutics Announces Completion of Enrollment in Phase 1b/2a Clinical Trial of AJ201 for the Treatment of Spinal and Bulbar Muscular Atrophy (Kennedy's Disease)

  • - Topline data remains on track for second quarter of 2024 - MIAMI, Jan. 02, 2024 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases, today announced that all patients have been enrolled in the Phase 1b/2a clinical trial of AJ201 for the treatment of spinal and bulbar muscular atrophy (“SBMA”), also known as Kennedy's Disease. AJ201 is currently the lead drug candidate in the clinic for SBMA, and topline data are anticipated in the second quarter of 2024.
  • 01/02/2024

Avenue Therapeutics to Present at American Epilepsy Society 2023 Annual Meeting

  • MIAMI, Dec. 01, 2023 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases, today announced that Amy Chappell, M.D., FAAN, will be presenting preclinical in vivo data evaluating BAER-101 using the SynapCell's Genetic Absence Epilepsy Rat from Strasbourg (“GAERS”) model of absence epilepsy at the American Epilepsy Society (AES) 2023 Annual Meeting in Orlando, FL on December 2, 2023.
  • 12/01/2023

Why Is Avenue Therapeutics (ATXI) Stock Up 59% Today?

  • Avenue Therapeutics (NASDAQ: ATXI ) stock is rising higher after the company revealed a major investment from Robert Davidow. According to a filing with the Securities and Exchange Commission (SEC), Davidow now holds a 14.5% stake in the specialty pharmaceutical company.
  • 11/29/2023

Avenue Therapeutics Reports Third Quarter 2023 Financial Results and Recent Corporate Highlights

  • - Phase 1b/2a clinical trial of AJ201 remains on track to report topline data in second quarter of 2024 - - Positive BAER-101 preclinical data accepted for presentation at American Epilepsy Society (AES) Annual Meeting - - Agreement reached with U.S. FDA on study design and analysis approach for Phase 3 safety study of IV tramadol - - Raised $5 million in gross proceeds from public equity offering - MIAMI, Nov. 13, 2023 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases, today reported financial results and recent corporate highlights for the third quarter ended September 30, 2023. “In the third quarter, Avenue continued to successfully execute across our pipeline of innovative CNS treatments," said Alexandra MacLean, M.D.
  • 11/13/2023

Avenue Therapeutics Announces Closing of $5.0 Million Public Offering

  • MIAMI, Nov. 02, 2023 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases, today announced the closing of its previously announced public offering of an aggregate of 16,633,400 units (or pre-funded units in lieu thereof) at a public offering price of $0.3006 per unit (inclusive of the pre-funded warrant exercise price of $0.0001 per share). Each unit consisted of (i) one share of common stock (or one pre-funded warrant in lieu thereof), (ii) one Series A warrant to purchase one share of common stock, immediately exercisable at a price of $0.3006 per share and expiring five years from the date of issuance, and (iii) one Series B warrant to purchase one share of common stock, immediately exercisable at a price of $0.3006 per share and expiring eighteen months from the date of issuance. The gross proceeds from the offering, before deducting the placement agent's fees and other offering expenses, are approximately $5.0 million.
  • 11/02/2023

Avenue Therapeutics Announces Pricing of $5.0 Million Public Offering

  • MIAMI, Oct. 31, 2023 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases, today announced the pricing of its public offering of an aggregate of 16,633,400 units at a public offering price of $0.3006 per unit. Each unit consists of (i) one share of common stock (or one pre-funded warrant in lieu thereof), (ii) one Series A warrant to purchase one share of common stock, immediately exercisable at a price of $0.3006 per share and expiring five years from the date of issuance, and (iii) one Series B warrant to purchase one share of common stock, immediately exercisable at a price of $0.3006 per share and expiring eighteen months from the date of issuance. The gross proceeds from the offering, before deducting the placement agent's fees and other offering expenses, are expected to be approximately $5.0 million.
  • 10/31/2023

Avenue Therapeutics to Present at H.C. Wainwright 25th Annual Global Investment Conference

  • MIAMI, Sept. 05, 2023 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases, today announced that Alexandra MacLean, M.D., Chief Executive Officer, will present a corporate update at the H.C. Wainwright 25th Annual Global Investment Conference scheduled to take place September 11-13, 2023. The presentation will be available for on-demand viewing starting Monday, September 11, 2023 at 7:00 a.m. ET.
  • 09/05/2023

Avenue Therapeutics Reports Second Quarter 2023 Financial Results and Recent Corporate Highlights

  • - First patient dosed in Phase 1b/2a clinical trial of AJ201; topline data anticipated in first half of 2024 - - Positive BAER-101 preclinical data demonstrate excellent anti-seizure activity in translational animal model; Phase 2a trial in epilepsy planned to initiate in 2024 - - Agreement reached with U.S. FDA on study design and analysis approach for Phase 3 safety study of IV tramadol - MIAMI, Aug. 10, 2023 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases, today reported financial results and recent corporate highlights for the second quarter ended June 30, 2023. “Avenue continues to make significant progress across our compelling pipeline of first- and best-in-class neurologic therapies for patients facing great unmet need," said Alexandra MacLean, M.D.
  • 08/10/2023

Avenue Therapeutics Announces High Potency and Full Efficacy in a Model of Generalized Seizures for its Novel GABA-A Receptor Potentiator, BAER-101, Supporting Phase 2 Clinical Study

  • -A Phase 2a study of BAER-101 in epilepsy is planned to initiate in 2024 -A Phase 2a study of BAER-101 in epilepsy is planned to initiate in 2024
  • 08/01/2023

Avenue Therapeutics to Present at Aegis Capital Virtual Conference

  • MIAMI, April 27, 2023 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases, today announced that Alexandra MacLean, M.D., Chief Executive Officer, will present a corporate update at the Aegis Capital Virtual Conference taking place on Thursday, May 4, 2023, at 4:00 p.m. EDT.
  • 04/27/2023

These Were The Five Best And Worst Performing Healthcare Stocks In September 2022

  • September was another lackluster month for the stock market, with the S&P 500 dropping by over 9%.
  • 10/17/2022

New to Trading Penny Stocks? Must Knows in 2022

  • Are these methods part of your penny stocks trading strategy The post New to Trading Penny Stocks? Must Knows in 2022 appeared first on Penny Stocks to Buy, Picks, News and Information | PennyStocks.com.
  • 10/16/2022

What In The World Is Going On With Avenue Therapeutics Stock?

  • Avenue Therapeutics Inc (NASDAQ: ATXI) shares are trading lower by 62.64% to $2.35 Friday morning after the company priced a roughly 3.6 million unit offering at $3.30 per unit.
  • 10/07/2022

ATXI Stock Alert: What to Know as Avenue Therapeutics Soars 150%

  • It's been another bumpy day in the stock market, with many stocks opening higher only to lose momentum this afternoon. That said, some companies are outperforming meaningfully today.
  • 09/27/2022

What Is Going on With Avenue Therapeutics (ATXI) Stock Today?

  • Source: Numstocker/Shutterstock.com Avenue Therapeutics (NASDAQ: ATXI ) stock is seeing wild movement on Friday following a reverse stock split and regulatory update. Starting with that reverse stock split, the company consolidated 15 shares of ATXI stock into a single share.
  • 09/23/2022

Avenue Therapeutics (ATXI) Stock: 1-For-15 Reverse Split Goes Into Effect

  • A 1-for-15 reverse split of Avenue Therapeutics (ATXI) has gone into effect. These are the details.
  • 09/23/2022

Reddit Penny Stocks to Watch as September Ends

  • Check these Reddit penny stocks out for your watchlist right now The post Reddit Penny Stocks to Watch as September Ends  appeared first on Penny Stocks to Buy, Picks, News and Information | PennyStocks.com.
  • 09/23/2022

Hot Penny Stocks To Buy For Under $0.99 This Week

  • Penny stocks under $1 to watch this week. The post Hot Penny Stocks To Buy For Under $0.99 This Week appeared first on Penny Stocks to Buy, Picks, News and Information | PennyStocks.com.
  • 09/08/2022

Top Biotech Penny Stocks to Buy Now? 3 to Watch in March

  • Check these three biotech penny stocks out for your watchlist The post Top Biotech Penny Stocks to Buy Now? 3 to Watch in March  appeared first on Penny Stocks to Buy, Picks, News and Information | PennyStocks.com.
  • 03/11/2022

Trading Penny Stocks? Top Stock Market News for March 2nd, 2022

  • Here's what you need to know about trading penny stocks on March 2nd The post Trading Penny Stocks? Top Stock Market News for March 2nd, 2022 appeared first on Penny Stocks to Buy, Picks, News and Information | PennyStocks.com.
  • 03/02/2022

Avenue Therapeutics (ATXI) Stock: Why The Price Surged

  • The stock price of Avenue Therapeutics Inc (NASDAQ: ATXI) increased by 53.15% in the most recent trading session. This is why it happened.
  • 11/30/2021

Why Novavax, Orphazyme, Avenue Therapeutics Shares Are Moving Monday

  • Novavax, Inc. (NASDAQ: NVAX), Orphazyme A/S (NASDAQ: ORPH) and Avenue Therapeutics, Inc. (NASDAQ: ATXI) are among the biggest movers among biopharma stocks Monday. Novavax Finally Releases Phase 3 COVID-19 Results: After a protracted delay, Gaithersburg, Maryland-based Novavax reported preliminary results showing its coronavirus candidate NVX-CoV2371 met the primary endpoint of the Phase 3 PREVENT trial in the U.S. and Mexico.
  • 06/14/2021

Avenue Therapeutics Receives Complete Response Letter from the FDA for IV Tramadol

  • NEW YORK, June 14, 2021 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (NASDAQ: ATXI) (“Avenue”), a company focused on the development of intravenous (“IV”) tramadol for the U.S. market, today announced that it has received a second Complete Response Letter (“CRL”) from the U.S. Food and Drug Administration (“FDA”) regarding its New Drug Application (“NDA”) seeking approval for IV tramadol.
  • 06/14/2021

SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Avenue Therapeutics, Inc. - ATXI

  • New York, New York--(Newsfile Corp. - April 21, 2021) - Pomerantz LLP is investigating claims on behalf of investors of Avenue Therapeutics Inc. ("Avenue" or the "Company") (NASDAQ: ATXI). Such investors are advised to contact Robert S. Willoughby at newaction@pomlaw.com or 888-476-6529, ext. 7980.The investigation concerns whether Avenue and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices. [Click here for information about...
  • 04/21/2021

SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Avenue Therapeutics, Inc. - ATXI

  • NEW YORK, April 19, 2021 /PRNewswire/ -- Pomerantz LLP is investigating claims on behalf of investors of  Avenue Therapeutics Inc. ("Avenue" or the "Company") (NASDAQ: ATXI).  Such investors are advised to contact Robert S.
  • 04/19/2021

Avenue Therapeutics (ATXI) Sees Hammer Chart Pattern: Time to Buy?

  • Avenue Therapeutics (ATXI) has been struggling lately, but the selling pressure may be coming to an end soon
  • 04/19/2021

SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Avenue Therapeutics, Inc. - ATXI

  • NEW YORK, April 13, 2021 /PRNewswire/ -- Pomerantz LLP is investigating claims on behalf of investors of  Avenue Therapeutics Inc. ("Avenue" or the "Company") (NASDAQ: ATXI).  Such investors are advised to contact Robert S.
  • 04/13/2021

ATXI Stock: Over 15% Decrease Pre-Market Explanation

  • The stock price of Avenue Therapeutics, Inc. (Nasdaq: ATXI) fell by over 15% pre-market. This is why it happened.
  • 04/13/2021

Avenue Therapeutics Announces that the FDA is Still Reviewing Its NDA Resubmission for IV Tramadol

  • The FDA Has Not Provided a Decision Regarding the NDA The FDA Has Not Provided a Decision Regarding the NDA
  • 04/13/2021

ATXI Stock: Over 15% Increase Pre-Market Explanation

  • The stock price of Avenue Therapeutics Inc (NASDAQ: ATXI) increased by over 15% pre-market. This is why it happened.
  • 04/12/2021

Avenue Therapeutics Announces Publication of Tramadol Non-Medical Use in Four European Countries: A Comparative Analysis

  • NEW YORK, Dec. 18, 2020 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (NASDAQ: ATXI) (Avenue), a company focused on the development of intravenous (IV) tramadol for the U.S. market, today announced that a publication titled “Tramadol Non-Medical Use in Four European Countries: A Comparative Analysis” has been published in Drug and Alcohol Dependence, a peer-reviewed international journal devoted to research, reviews, commentaries, and policy analyses in the area of drug, alcohol and tobacco use and dependence. The publication can be accessed here.
  • 12/18/2020

Why Fortress Biotech Stock Jumped Today

  • One of the company's subsidiaries announced some good news today.
  • 12/17/2020

The Daily Biotech Pulse: CureVac Close To Coronavirus Vaccine Deal With EU, Entera Bio's Positive Readout, Patent Protection For Co-Diagnostics

  • Scaling The Peaks (Biotech Stocks Hitting 52-week Highs Aug. 19) 10X Genomics Inc (NASDAQ: TXG) ALX Oncology Holdings Inc (NASDAQ: ALXO) Avenue Therapeutics Inc (NASDAQ: ATXI)...
  • 08/20/2020

The Daily Biotech Pulse: Gilead's Filgotinib Stumbles With FDA, J&J Laps Up Momenta In $6.5B Deal, 2 IPOs

  • Scaling The Peaks (Biotech Stocks Hitting 52-week Highs Aug. 18) Avenue Therapeutics Inc (NASDAQ: ATXI) Checkmate Pharmaceuticals Inc (NASDAQ: CMPI) DarioHealth Corp (NASDAQ:...
  • 08/19/2020

Avenue Therapeutics (ATXI) Misses Earnings Estimates in Q2

  • Avenue Therapeutics (ATXI) reports a wider-than-expected loss in the second quarter of 2021.
  • 08/17/2020

Avenue Therapeutics Reports Second Quarter 2020 Financial Results and Recent Corporate Highlights

  • NEW YORK, Aug. 14, 2020 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (NASDAQ: ATXI) (“Avenue”), a company focused on the development of intravenous (“IV”) tramadol for the U.S. market, today reported financial results and recent corporate highlights for the second quarter ended June 30, 2020. “We were pleased to announce several publications pertaining to IV tramadol in peer-reviewed journals recently. These publications highlight the positive data and accomplishments from our Phase 3 program,” said Lucy Lu, M.D., Avenue’s President and CEO. “We look forward to an eventful second half of 2020 as we approach IV tramadol’s Prescription Drug User Fee Act (“PDUFA”) date of October 10, 2020.”Recent Corporate Highlights: * In April 2020, Avenue announced that two e-posters highlighting efficacy and safety results from its Phase 3 program were available for online viewing from the cancelled Annual Regional Anesthesiology and Acute Pain Medicine Meeting hosted by the American Society of Regional Anesthesia and Pain Medicine. * The e-poster (816) titled “Intravenous Tramadol is Effective in Management of Postoperative Pain Following Abdominoplasty: A 3-arm Randomized Controlled Trial” presents data from the Phase 3 abdominoplasty study and can be found here. * The e-poster (1001) titled “IV tramadol – A New Treatment Option for Management of Post-Operative Pain: A Safety Trial Including Various Types of Surgery” presents data from the Phase 3 safety study and can be found here. * In June 2020, Avenue announced the following clinical study publications in peer-reviewed journals. * The publication titled “Intravenous Tramadol is Effective in the Management of Postoperative Pain Following Abdominoplasty: A Three-Arm Randomized Placebo- and Active-Controlled Trial” was published in Drugs in R&D and can be accessed here. * The publication titled “IV Tramadol – A New Treatment Option for Management of Post-Operative Pain in the U.S: An Open-Label, Single-Arm, Safety Trial Including Various Types of Surgery” was published in Journal of Pain Research and can be accessed here. * In July 2020, Avenue announced the following publication of its Phase 3 bunionectomy study. * The publication titled “Efficacy and Safety of Intravenously Administered Tramadol in Patients with Moderate to Severe Pain Following Bunionectomy:  A Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study” was published in Pain and Therapy and can be accessed here.2020 Financial Results: * Cash Position: As of June 30, 2020, Avenue’s cash and cash equivalents totaled $5.3 million, compared to $6.6 million at March 31, 2020 and $8.7 million at December 31, 2019, a decrease of $1.3 million for the quarter and a decrease of $3.4 million year-to-date.     * R&D Expenses: Research and development expenses for the second quarter of 2020 were $1.2 million, compared to $6.4 million in the second quarter of 2019. This decrease of $5.2 million was primarily attributable to the completion of the abdominoplasty and safety studies in 2019. * G&A Expenses: General and administrative expenses for the second quarters of 2020 and 2019 were flat at approximately $0.7 million, each. * Net Loss: Net loss attributable to common stockholders for the second quarter of 2020 was $1.9 million, or $0.11 per share, compared to a net loss of $7.0 million, or $0.43 per share, in the second quarter of 2019.About Avenue Therapeutics Avenue Therapeutics is a specialty pharmaceutical company whose mission is to develop IV tramadol, a potential alternative that could reduce the use of conventional opioids, for patients suffering from acute pain in the U.S. Avenue is headquartered in New York City and was founded by Fortress Biotech, Inc. (NASDAQ: FBIO). For more information, visit www.avenuetx.com.  Forward-Looking Statements This press release may contain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, each as amended. Such statements include, but are not limited to, any statements relating to our growth strategy and product development programs and any other statements that are not historical facts. Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock value. Factors that could cause actual results to differ materially from those currently anticipated include: risks related to us obtaining regulatory approval from the FDA for our product candidate, risks relating to the COVID-19 outbreak and its potential impact on our employees’ and consultants’ ability to complete work in a timely manner, risks relating to our growth strategy; risks relating to the results of research and development activities; risks relating to the timing of starting and completing clinical trials; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; uncertainties relating to preclinical and clinical testing; our dependence on third-party suppliers; our ability to attract, integrate and retain key personnel; the early stage of products under development; our need for substantial additional funds; government regulation; patent and intellectual property matters; competition; as well as other risks described in our SEC filings. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.Contacts: Jaclyn Jaffe and William Begien Avenue Therapeutics, Inc. (781) 652-4500 ir@avenuetx.com AVENUE THERAPEUTICS, INC. Condensed Balance Sheets ($ in thousands, except for share and per share amounts)                    June 30, December 31,       2020   2019       (unaudited)                ASSETS        Current Assets:        Cash and cash equivalents$5,257  $8,745      Prepaid expenses and other current assets 74   170      Total Assets$ 5,331  $ 8,915               LIABILITIES AND STOCKHOLDERS' EQUITY        Current Liabilities:        Accounts payable and accrued expenses$1,193  $1,101      Accounts payable and accrued expenses - related party 37   14      Licenses payable -   1,000      Total current liabilities 1,230   2,115               Total Liabilities 1,230   2,115               Commitments and Contingencies                  Stockholders' Equity        Preferred Stock ($0.0001 par value), 2,000,000 shares authorized        Class A Preferred Stock, 250,000 shares issued and outstanding as of June 30, 2020 and December 31, 2019, respectively -   -      Common Stock ($0.0001 par value), 50,000,000 shares authorized        Common shares, 16,702,803 and 16,682,190 shares issued and outstanding as of June 30, 2020 and December 31, 2019, respectively 2   2      Additional paid-in capital 75,346   74,915      Accumulated deficit (71,247)  (68,117)     Total Stockholders' Equity 4,101   6,800      Total Liabilities and Stockholders' Equity$ 5,331  $ 8,915              AVENUE THERAPEUTICS, INC. Condensed Statements of Operations ($ in thousands, except for share and per share amounts) (Unaudited)              For the Three Months Ended For the Six Months Ended    June 30, June 30, June 30, June 30,     2020   2019   2020   2019    Operating expenses:          Research and development$1,219  $6,392  $1,916  $16,633    General and administrative 684   716   1,261   1,835    Loss from operations (1,903)  (7,108)  (3,177)  (18,468)              Interest income (15)  (126)  (47)  (217)   Net Loss$ (1,888) $ (6,982) $ (3,130) $ (18,251)              Net loss per common share outstanding, basic and diluted$(0.11) $(0.43) $(0.19) $(1.21)              Weighted average number of common shares outstanding, basic and diluted 16,474,655   16,314,763   16,474,655   15,035,811
  • 08/14/2020

What's in Store for Avenue Therapeutics (ATXI) in Q2 Earnings?

  • Avenue Therapeutics' (ATXI) sole pipeline candidate, tramadol, is under review. With lower clinical activities, operating expenses are likely to have declined during the second quarter.
  • 08/04/2020

Avenue Therapeutics, Inc. (ATXI) Dips More Than Broader Markets: What You Should Know

  • Avenue Therapeutics, Inc. (ATXI) closed the most recent trading day at $10.30, moving -1.9% from the previous trading session.
  • 07/28/2020

Avenue Therapeutics, Inc. (ATXI) Stock Sinks As Market Gains: What You Should Know

  • Avenue Therapeutics, Inc. (ATXI) closed the most recent trading day at $10.40, moving -1.61% from the previous trading session.
  • 07/22/2020

Avenue Therapeutics Announces Publication of Phase 3 Bunionectomy Study Results

  • NEW YORK, July 21, 2020 -- Avenue Therapeutics, Inc. (NASDAQ: ATXI) (“Avenue”), a company focused on the development of intravenous (“IV”) tramadol for the U.S. market, today.
  • 07/21/2020

Avenue Therapeutics, Inc. (ATXI) Dips More Than Broader Markets: What You Should Know

  • Avenue Therapeutics, Inc. (ATXI) closed the most recent trading day at $9.83, moving -0.91% from the previous trading session.
  • 07/16/2020

Avenue Therapeutics, Inc. (ATXI) Dips More Than Broader Markets: What You Should Know

  • Avenue Therapeutics, Inc. (ATXI) closed the most recent trading day at $9.75, moving -1.52% from the previous trading session.
  • 07/09/2020

Is Avenue Therapeutics (ATXI) Stock Outpacing Its Medical Peers This Year?

  • Is (ATXI) Outperforming Other Medical Stocks This Year?
  • 07/09/2020

Pacira (PCRX) Provides Preliminary Results for Second Quarter

  • Pacira (PCRX) reports preliminary results for the second quarter of 2020. The company's product sales are hurt by the COVID-19 pandemic. The stock fell in pre-market trading.
  • 07/07/2020

Fortress Biotech Added to Russell 3000® Index

  • Annual Russell indexes’ reconstitution captures the 4,000 largest U.S. stocks as of May 8, ranking them by total market capitalization. Membership in the U.S. all-cap Russell 3000® Index, which remains in place for one year, means automatic inclusion in the large-cap Russell 1000® Index or small-cap Russell 2000® Index, as well as the appropriate growth and value style indexes.
  • 06/29/2020

Veru (VERU) Soars: Stock Adds 6.9% in Session

  • Veru (VERU) saw a big move last session, as its shares jumped nearly 7% on the day, amid huge volumes.
  • 06/25/2020

Avenue Therapeutics, Inc. (ATXI) Upgraded to Strong Buy: Here's What You Should Know

  • Avenue Therapeutics, Inc. (ATXI) might move higher on growing optimism about its earnings prospects, which is reflected by its upgrade to a Zacks Rank 1 (Strong Buy).
  • 06/24/2020

New Strong Buy Stocks for June 24th

  • New Strong Buy Stocks for June 24th
  • 06/24/2020

Avenue Therapeutics' Shares March Higher, Can It Continue?

  • As of late, it has definitely been a great time to be an investor in Avenue Therapeutics
  • 06/23/2020

Aclaris Gets FDA Nod to Start Investigator-led Coronavirus Study

  • Aclaris (ACRS) announces that it supports an IND application to evaluate its oral investigational MK2 inhibitor compound, ATI-450, in hospitalized patients with COVID-19.
  • 06/18/2020

NGM Biopharmaceuticals (NGM) Soars: Stock Adds 7.8% in Session

  • NGM Biopharmaceuticals (NGM) saw a big move last session, as its shares jumped nearly 8% on the day, amid huge volumes.
  • 06/18/2020

Is Avenue Therapeutics (ATXI) Outperforming Other Medical Stocks This Year?

  • Is (ATXI) Outperforming Other Medical Stocks This Year?
  • 06/17/2020

AVENUE THERAPEUTICS, INC. : Submission of Matters to a Vote of Security Holders (form 8-K) | MarketScreener

  • 06/16/2020

Provention Bio (PRVB) Looks Good: Stock Adds 8.6% in Session

  • Provention Bio (PRVB) saw a big move last session, as its shares jumped nearly 9% on the day, amid huge volumes.
  • 06/16/2020

Zacks.com featured highlights include: Frontline, iClick Interactive Asia, Avenue Therapeutics, ProQR Therapeutics and BJ???s Wholesale Club

  • Zacks.com featured highlights include: Frontline, iClick Interactive Asia, Avenue Therapeutics, ProQR Therapeutics and BJ???s Wholesale Club
  • 06/15/2020

NantHealth (NH) Looks Good: Stock Adds 9.1% in Session

  • NantHealth (NH) saw a big move last session, as its shares jumped more than 9% on the day, amid huge volumes.
  • 06/11/2020

Otonomy (OTIC) in Focus: Stock Moves 6.1% Higher

  • Otonomy (OTIC) saw a big move last session, as its shares jumped more than 6% on the day, amid huge volumes.
  • 06/11/2020

Recro Pharma (REPH) in Focus: Stock Moves 7.6% Higher

  • Recro Pharma (REPH) saw a big move last session, as its shares jumped nearly 8% on the day, amid huge volumes.
  • 06/10/2020

Zacks.com featured highlights include: Avenue Therapeutics, Calix, ChannelAdvisor and Magic Software Enterprises

  • Zacks.com featured highlights include: Avenue Therapeutics, Calix, ChannelAdvisor and Magic Software Enterprises
  • 06/09/2020

4 Affordable Breakout Stocks for Stunning Returns

  • Selecting breakout stocks continue to be one of the most popular methods utilized by active investors.
  • 06/08/2020

Avenue Therapeutics Announces Publications in Peer-Reviewed Journals

  • The publication titled “Intravenous Tramadol is Effective in the Management of Postoperative Pain Following Abdominoplasty: A Three-Arm Randomized Placebo- and Active-Controlled Trial” has been published in Drugs in R&D; and can be accessed here. The objective of this Phase 3 study was to evaluate the safety, tolerability and efficacy of IV tramadol 50 mg versus placebo in patients following abdominoplasty surgery, a soft-tissue surgical model.
  • 06/05/2020

Avenue Therapeutics' Shares March Higher, Can It Continue?

  • As of late, it has definitely been a great time to be an investor in Avenue Therapeutics
  • 05/29/2020

Zacks.com featured highlights include: Minerva Neurosciences, Liquidia Technologies, Calix, Avenue Therapeutics and ExOne

  • Zacks.com featured highlights include: Minerva Neurosciences, Liquidia Technologies, Calix, Avenue Therapeutics and ExOne
  • 05/29/2020

Avenue Therapeutics to Host Virtual Annual Meeting of Stockholders

  • Holding the Annual Meeting online will also protect the health and safety of the Company’s stockholders, directors and employees. The Annual Meeting will begin at 10:00 a.m. Eastern Time on Tuesday, June 16, 2020, and will be conducted in a virtual format only. Stockholders will not be able to attend the Annual Meeting in person; however, stockholders of record as of the close of business on April 20, 2020 will be able to vote through the online platform.
  • 05/29/2020

Flexion (FLXN) Soars: Stock Adds 6.6% in Session

  • Flexion (FLXN) saw a big move last session, as its shares jumped more than 6% on the day, amid huge volumes.
  • 05/28/2020

Hedge Funds Watching Avenue Therapeutics, Inc. (ATXI) From Afar

  • We at Insider Monkey have gone over 821 13F filings that hedge funds and prominent investors are required to file by the SEC The 13F filings show the funds' and investors' portfolio positions as of March 31st, near the height of the coronavirus market crash. In this article, we look at what those funds think […]
  • 05/27/2020

Is Avenue Therapeutics (ATXI) Stock Outpacing Its Medical Peers This Year?

  • Is (ATXI) Outperforming Other Medical Stocks This Year?
  • 05/27/2020

Small Drug Industry Prospects Bright Amid Coronavirus Gloom

  • Small Drug Industry Prospects Bright Amid Coronavirus Gloom
  • 05/27/2020

Zacks.com featured highlights include: Veritone, Avenue Therapeutics, Turtle Beach, BJ???s Wholesale Club and Atlas Air Worldwide

  • Zacks.com featured highlights include: Veritone, Avenue Therapeutics, Turtle Beach, BJ???s Wholesale Club and Atlas Air Worldwide
  • 05/26/2020

Zacks.com featured highlights include: Avenue Therapeutics, Glu Mobile, Yamana Gold and Z Holdings

  • Zacks.com featured highlights include: Avenue Therapeutics, Glu Mobile, Yamana Gold and Z Holdings
  • 05/26/2020

How Avenue (ATXI) Stock Stands Out in a Strong Industry

  • Avenue (ATXI) has seen solid earnings estimate revision activity over the past month, and belongs to a strong industry as well.
  • 05/26/2020

Pick These 5 Stocks With Superb Relative Price Strength

  • Want to try an out-of-the-box approach to earn handsome returns? Tap these stocks with explosive relative price strength.
  • 05/22/2020

4 Breakout Stocks for Impressive Returns

  • The logic behind the breakout strategy for stock selection is to identify stocks are trading within a narrow band.
  • 05/22/2020

Avenue Therapeutics Reports First Quarter 2020 Financial Results and Recent Corporate Highlights

  • NEW YORK, May 11, 2020 -- Avenue Therapeutics, Inc. (NASDAQ: ATXI) (“Avenue”), a company focused on the development of intravenous (“IV”) tramadol for the U.S. market, today.
  • 05/11/2020

Corcept (CORT) Q1 Earnings Top Estimates, Revenues Rise Y/Y

  • Stocks Analysis by Zacks Investment Research covering: Celgene Corporation, Bristol-Myers Squibb Company, Corcept Therapeutics Incorporated, Avenue Therapeutics Inc. Read Zacks Investment Research's latest article on Investing.com
  • 05/05/2020

Vaxart (VXRT) to Report Q1 Earnings: What's in the Cards?

  • During Vaxart's (VXRT) upcoming Q1 earnings call, investor focus will be on the company's progress with its oral vaccine candidates against SARS CoV-2.
  • 04/29/2020

The Zacks Analyst Blog Highlights: Cue Biopharma, PJT Partners, Avenue Therapeutics, SpartanNash and Gaia

  • The Zacks Analyst Blog Highlights: Cue Biopharma, PJT Partners, Avenue Therapeutics, SpartanNash and Gaia
  • 04/24/2020

The Zacks Analyst Blog Highlights: Cue Biopharma, PJT Partners, Avenue Therapeutics, SpartanNash and Gaia

  • The Zacks Analyst Blog Highlights: Cue Biopharma, PJT Partners, Avenue Therapeutics, SpartanNash and Gaia
  • 04/24/2020

Avenue Therapeutics Announces Presentation of IV Tramadol E-Posters

  • The e-poster (816) titled “Intravenous Tramadol is Effective in Management of Postoperative Pain Following Abdominoplasty: A 3-arm Randomized Controlled Trial” presents data from the Phase 3 abdominoplasty study and can be found here. This Phase 3, multicenter, double-blind, placebo and active controlled trial evaluated the efficacy and safety of IV tramadol in 370 patients following abdominoplasty surgery. Patients were randomized to a postoperative regimen of IV tramadol 50 mg, placebo or IV morphine 4 mg. The primary endpoint of the study assessed the analgesic efficacy of IV tramadol compared to placebo as measured by SPID24 (sum of pain intensity differences through 24 hours post first dose).
  • 04/23/2020

5 Top Small-Cap Stocks Braving Coronavirus Bloodbath

  • A handful of small-cap stocks have skyrocketed defying the coronavirus-induced market mayhem and extreme volatility.
  • 04/23/2020

Avenue Therapeutics (ATXI) Gets a Buy Rating from Oppenheimer

  • In a report released today, Leland Gershell from Oppenheimer maintained a Buy rating on Avenue Therapeutics (ATXI), with a price target of $12.00. The
  • 03/31/2020

Avenue Therapeutics (ATXI) Gets a Buy Rating from Oppenheimer

  • In a report released today, Leland Gershell from Oppenheimer maintained a Buy rating on Avenue Therapeutics ( ATXI – Research Report ), with a price target of $12.00 . The company’s shares closed last Tuesday at $8.97. According to TipRanks.com , Ger
  • 03/31/2020

Analysts' Top Healthcare Picks: Axsome Therapeutics (AXSM), Phasebio Pharmaceuticals (PHAS)

  • There's a lot to be optimistic about in the Healthcare sector as 3 analysts just weighed in on Axsome Therapeutics (AXSM), Phasebio Pharmaceuticals (PHAS)
  • 03/31/2020

Analysts’ Top Healthcare Picks: Axsome Therapeutics (AXSM), Phasebio Pharmaceuticals (PHAS)

  • There’s a lot to be optimistic about in the Healthcare sector as 3 analysts just weighed in on Axsome Therapeutics
  • 03/31/2020

Avenue Therapeutics Reports Full Year 2019 Financial Results and Recent Corporate Highlights

  • NEW YORK, March 30, 2020 -- Avenue Therapeutics, Inc. (NASDAQ: ATXI) (“Avenue”), a company focused on the development of intravenous (“IV”) tramadol for the U.S. market, today.
  • 03/30/2020

The Daily Biotech Pulse: Novartis Earnings, Hepion's NASH Candidate Beats Rival Drugs, Annovis Bio To Debut

  • Here's a roundup of top developments in the biotech space over the last 24 hours. Scaling The Peaks (Biotech Stocks Hitting 52-week highs on Jan. 28) 10X Genomics Inc (NASDAQ: TXG ) Acceleron Pharma Inc ...
  • 01/29/2020

What we know about the woman who gave Laura Plummer Tramadol

  • Laura Plummer claims a 'friend' from work gave her the tablets
  • 01/31/2019
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