New Strong Sell Stocks for November 10th
- AMYT, CHRD and BKI have been added to the Zacks Rank #5 (Strong Sell) List on November 10, 2022.
- 11/10/2022
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Amryt Pharma PLC (AMYT) Q3 2022 Earnings Call Transcript
- Amryt Pharma PLC (NASDAQ:AMYT ) Q3 2022 Earnings Conference Call November 3, 2022 8:30 AM ET Company Participants Simon Loughrey - Group Financial Controller Joseph Wiley - CEO & Director Rory Nealon - CFO, COO & Company Secretary Sheila Frame - President, Americas Tracy Cunningham - Chief Medical Officer Conference Call Participants Brandon Folkes - Cantor Fitzgerald Edward Nash - Canaccord Genuity Catherine Novack - Jones Research Brian White - Shore Capital Group Douglas Tsao - H.C. Wainwright & Co. Operator Good morning, and welcome to the Amryt Pharma Q3 2022 Results Call and Webcast.
- 11/05/2022
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Amryt to Report Q3 2022 Results on November 3, 2022
- A mryt to Report Q 3 202 2 Results on November 3 , 2022
- 10/19/2022
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Amryt to Present Data from MPOWERED Phase 3 Trial of Mycapssa® (oral octreotide) at ENEA 2022
- Amryt to Present Data from MPOWERED Phase 3 Trial of Mycapssa® (oral octreotide) at ENEA 2022
- 09/07/2022
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Amryt Pharma plc (AMYT) CEO Joseph Wiley on Q2 2022 Results - Earnings Call Transcript
- Amryt Pharma plc (NASDAQ:AMYT ) Q2 2022 Earnings Conference Call August 4, 2022 8:30 AM ET Company Participants Simon Loughrey - Group Financial Controller Joseph Wiley - Chief Executive Officer Rory Nealon - Chief Financial Officer and Chief Operating Officer Jordi Casals - President of EMEA Region Sheila Frame - President of Americas Tracy Cunningham - Chief Medical Officer Conference Call Participants Brandon Folkes - Cantor Fitzgerald & Co. Catherine Novack - Jones Research Douglas Tsao - H.C. Wainwright & Co. Max Herrmann - Stifel, Nicolaus & Company, Inc. Brian White - Shore Capital Stockbrokers Ltd.
- 08/06/2022
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Amryt Pharma PLC Sponsored ADR (AMYT) Reports Q2 Loss, Tops Revenue Estimates
- Amryt Pharma PLC Sponsored ADR (AMYT) delivered earnings and revenue surprises of 50% and 9.55%, respectively, for the quarter ended June 2022. Do the numbers hold clues to what lies ahead for the stock?
- 08/04/2022
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Amryt to Report Q2 2022 Results on August 4, 2022
- DUBLIN, Ireland, and Boston MA, July 21 , 202 2 , Amryt (Nasdaq: AMYT) a global, commercial-stage biopharmaceutical company dedicated to acquiring, developing and commercializing novel treatments for rare diseases, today announces that its unaudited financial results for the second quarter 2022 will be released on Thursday , August 4 , 202 2 at 0700 E T/1200 BST.
- 07/21/2022
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Amryt (AMYT) Mycapssa Gets Orphan Drug Tag for Carcinoid Syndrome
- The FDA bestows an Orphan Drug designation to Amryt's (AMYT) Mycapssa for the treatment of carcinoid syndrome. Stock up in pre-market trading.
- 07/14/2022
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Amryt Pharma PLC Sponsored ADR (AMYT) Surges 7.5%: Is This an Indication of Further Gains?
- Amryt Pharma PLC Sponsored ADR (AMYT) 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.
- 06/24/2022
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Amryt to Present Data from OPTIMAL and MPOWERED Phase 3 Trials Open Label Extension of Mycapssa® (oral octreotide) at ENDO 2022
- Amryt to Present Data from OPTIMAL and MPOWERED Phase 3 Trials Open Label Extension of Mycapssa® (oral octreotide) at ENDO 2022
- 06/08/2022
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Amryt Pharma PLC (AMYT) CEO Joseph Wiley on Q1 2022 Results - Earnings Call Transcript
- Amryt Pharma PLC (NASDAQ:AMYT ) Q1 2022 Earnings Conference Call May 4, 2022 8:30 AM ET Company Participants Simon Loughrey - Group Financial Controller Joseph Wiley - CEO & Director Rory Nealon - CFO, COO & Company Secretary Sheila Frame - President of Americas Tracy Cunningham - VP, Head of Development Paul Greenland - President, EMEA Region Conference Call Participants Max Herrmann - Stifel, Nicolaus & Company Mani Foroohar - SVB Leerink Catherine Novack - Jones Research Michelle Gilson - Canaccord Genuity Brandon Folkes - Cantor Fitzgerald & Co. Operator Good day, and thank you for standing by. Welcome to the Amryt Pharma Q1 Results Call.
- 05/08/2022
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Amryt Pharma PLC Sponsored ADR (AMYT) Reports Q1 Loss, Tops Revenue Estimates
- Amryt Pharma PLC Sponsored ADR (AMYT) delivered earnings and revenue surprises of 0% and 2.87%, respectively, for the quarter ended March 2022. Do the numbers hold clues to what lies ahead for the stock?
- 05/04/2022
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Amryt Shares Trading Higher As EMA Endorses Approval Of Filsuvez In Genetic Skin Disease
- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has backed the approval of Amryt Pharma Plc's (NASDAQ: AMYT) Filsuvez in the European Union for partial thickness wounds associated with dystrophic and junctional Epidermolysis Bullosa.
- 04/22/2022
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Amryt to Report Q1 2022 Results on May 4, 2022
- A mryt to Report Q1 202 2 Results on May 4 , 2022
- 04/14/2022
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Amryt Pharma (AMYT) CEO Dr. Joe Wiley on Q4 2021 Results - Earnings Call Transcript
- Amryt Pharma (AMYT) CEO Dr. Joe Wiley on Q4 2021 Results - Earnings Call Transcript
- 03/09/2022
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Amryt Pharma PLC Sponsored ADR (AMYT) Tops Q4 Earnings Estimates
- Amryt Pharma PLC Sponsored ADR (AMYT) delivered earnings and revenue surprises of 207.14% and 3.55%, respectively, for the quarter ended December 2021. Do the numbers hold clues to what lies ahead for the stock?
- 03/09/2022
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Amryt Pharma PLC Sponsored ADR (AMYT) Expected to Beat Earnings Estimates: What to Know Ahead of Q4 Release
- Amryt Pharma PLC Sponsored ADR (AMYT) possesses the right combination of the two key ingredients for a likely earnings beat in its upcoming report. Get prepared with the key expectations.
- 03/02/2022
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Amryt to Report FY and Q4 2021 Results on March 9, 2022
- A mryt to Report FY and Q4 202 1 Results on March 9, 2022
- 02/23/2022
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Amryt Pharma PLC Sponsored ADR (AMYT) Surges 5.5%: Is This an Indication of Further Gains?
- Amryt Pharma PLC Sponsored ADR (AMYT) 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.
- 01/18/2022
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Amryt Pharma: full Phase 3 trial results published by Lancet
- Amryt Pharma PLC (AIM:AMYT, NASDAQ:AMYT) has been boosted by positive trial results published by Lancet Diabetes & Endocrinology. The company, in a statement, told investors that the full results of The global Phase 3 MPOWERED clinical trial compared Mycapssa, oral octreotide capsules, to long-acting injectable Somatostatin Receptor Ligands (iSRLs) for maintenance of biochemical response in patients with acromegaly.
- 01/04/2022
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Amryt (AMYT) Skin Disorder NDA Review Gets 3 Months Extension
- Amryt (AMYT) is seeking approval for Oleogel-S10 for treating epidermolysis bullosa, a rare genetic skin disorder, in the United States and Europe. The FDA extends the review period for the drug's NDA to reviewnew data submission.
- 11/24/2021
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Amryt Pharma drug application review with FDA extended three months
- Amryt Pharma PLC (AIM:AMYT, NASDAQ:AMYT) said its forecasts for 2021 revenues would be unaffected after the US Food and Drug Administration made a three-month extension to the review period for the new drug application (NDA) for its Oleogel-S10 for the treatment of junctional and dystrophic epidermolysis bullosa. This is a rare and distressing genetic skin disorder affecting young children and adults for which there is currently no approved treatment.
- 11/23/2021
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Amryt Pharma (AMYT) CEO Dr. Joe Wiley on Q3 2021 Results - Earnings Call Transcript
- Amryt Pharma (AMYT) CEO Dr. Joe Wiley on Q3 2021 Results - Earnings Call Transcript
- 11/07/2021
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Amryt Pharma PLC Sponsored ADR (AMYT) Reports Q3 Loss, Tops Revenue Estimates
- Amryt Pharma PLC Sponsored ADR (AMYT) delivered earnings and revenue surprises of 66.67% and 7.98%, respectively, for the quarter ended September 2021. Do the numbers hold clues to what lies ahead for the stock?
- 11/03/2021
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Amryt Pharma third-quarter revenue up over 14% on soaring metreleptin sales
- Amryt Pharma PLC (AIM:AMYT, NASDAQ:AMYT) announced revenue growth of 14.6% for the third quarter after sales of its lipodystrophy treatment metreleptin soared 21.5%. Revenue rose to US$56.5mln in the three months to end-September from US$49.3mln in the same period last year.
- 11/03/2021
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Amryt Pharma backs EB awareness week
- Amryt Pharma PLC has announced its support for Global Epidermolysis Bullosa (EB) Awareness Week, which is taking place October 25 - 31, 2021. Joe Wiley, Amryt's chief executive, said: "Epidermolysis Bullosa is a very distressing condition which severely impacts the lives of those living with EB and also has a profound impact on parents, families and all those involved in their care.
- 10/22/2021
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Amryt to Report Q3 2021 Results and Host Conference Call & Webcast on November 3
- A mryt to Report Q 3 202 1 Results and Host Conference Call & Webcast on November 3
- 10/20/2021
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Amryt Pharma advancing on multiple fronts
- What the company does Amryt Pharma PLC (LON:AMYT) sells and develops orphan drugs used to treat rare diseases with two products on the market. Last year, Amryt acquired US group Aegerion Pharmaceuticals out of Chapter 11 bankruptcy protection in a transaction backed by convertible bondholders, creditors and Nasdaq-listed Novelion Therapeutics, Aegerion's parent company.
- 10/19/2021
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Amryt Pharma extends patent protection on key products
- Amryt has extended the patents on its lead development candidate, Oleogel-S10 and its recently acquired commercial product, Mycapssa. For Oleogel-S10, a treatment for skin condition EB, the US patent office has issued a new formulation patent to Amryt, which will be listable in the Approved Drug Products or “Orange Book”.
- 10/19/2021
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Amryt Announces New Patents for Oleogel-S10 and Mycapssa®
- Amryt Announces New Patents for Oleogel-S10 and Mycapssa®
- 10/19/2021
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Amryt Pharma impresses broker at Capital Markets Day
- Amryt Pharma has had its price target of US$40 and 'buy' rating reiterated by Canaccord after the company hosted a virtual capital markets day. Opinion leaders spoke on the near-term growth opportunities with Filsuvez in epidermolysis bullosa (EB) and Mycapssa in acromegaly, said the broker, which has underlined its optimistic view.
- 09/14/2021
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Amryt Pharma advancing on multiple fronts
- What the company does Amryt Pharma PLC (LON:AMYT) sells and develops orphan drugs used to treat rare diseases with two products on the market. Last year, Amryt acquired US group Aegerion Pharmaceuticals out of Chapter 11 bankruptcy protection in a transaction backed by convertible bondholders, creditors and Nasdaq-listed Novelion Therapeutics, Aegerion's parent company.
- 09/13/2021
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Amryt Pharma raises sales forecast again as acquisition makes strong start
- Amryt Pharma has raised its full-year 2021 revenue guidance due to a strong performance from recent acquisition of Chiasma and its own commercial products. Revenues are now expected in a range of US220mln - $225mln compared to previous guidance of US$210mln- $215mln.
- 09/13/2021
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Amryt Raises Full Year 2021 Revenue Guidance to $220M - $225M
- Amryt Raises Full Year 2021 Revenue Guidance to $220M - $225M
- 09/13/2021
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Amryt Pharma (AMYT) CEO Dr. Joe Wiley on Q2 2021 Results - Earnings Call Transcript
- Amryt Pharma (AMYT) CEO Dr. Joe Wiley on Q2 2021 Results - Earnings Call Transcript
- 08/08/2021
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Amryt Pharma ups guidance after record second quarter
- Amryt Pharma PLC has raised its full-year guidance after the biopharmaceutical company delivered a record set of results in its second quarter. In its results for the quarter ended June 30, the company reported an operating profit before finance expense of US$4.1mln, swinging from a US$12mln loss a year ago, while revenues surged 35.9% to US$62.8mln.
- 08/06/2021
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Amryt Reports Record Q2 2021 Results and Raises FY 2021 Guidance
- Amryt Reports Record Q2 2021 Results and Raises FY 2021 Guidance
- 08/06/2021
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Amryt Pharma advancing on multiple fronts
- What the company does Amryt Pharma PLC (LON:AMYT) sells and develops orphan drugs used to treat rare diseases with two products on the market. Last year, Amryt acquired US group Aegerion Pharmaceuticals out of Chapter 11 bankruptcy protection in a transaction backed by convertible bondholders, creditors and Nasdaq-listed Novelion Therapeutics, Aegerion's parent company.
- 08/05/2021
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Amryt Pharma completes Chiasma acquisition
- Amryt Pharma PLC has completed its acquisition of US group Chiasma Inc with Raj Kannan and Roni Mamluk joining the board as non-executive directors. Joe Wiley, Amryt's chief executive, said: “This transaction further solidifies our position as a global leader in treating rare and orphan conditions.
- 08/05/2021
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Result of General Meetings
- DUBLIN, Ireland, and Boston MA, July 28, 2021, Amryt (Nasdaq: AMYT, AIM: AMYT), a global, commercial-stage biopharmaceutical company dedicated to acquiring, developing and commercializing novel treatments for rare diseases, is pleased to announce that all resolutions presented to shareholders at both of today's General Meetings were duly passed.
- 07/28/2021
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Amryt to Report Q2 2021 Results and Host Conference Call & Webcast on August 6
- Amryt to Report Q2 2021 Results and Host Conference Call & Webcast on August 6
- 07/12/2021
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Publication of Circular to Amryt Shareholders in relation to the acquisition of Chiasma, Inc., and posting of Annual Report and Notices of General Meetings
- Publication of Circular to Amryt S hareholders in relation to the acquisition of Chiasma, Inc . , and p osting of Annual Report and Notice s of General Meeting s
- 06/28/2021
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Amryt Pharma Announces Filing of Preliminary Registration Statement on Form F-4 in Connection with Its Proposed Acquisition of Chiasma, Inc.
- Amryt Pharma Announces Filing of Preliminary Registration Statement on Form F-4 in Connection with Its Proposed Acquisition of Chiasma, Inc.
- 06/15/2021
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Amryt Pharma Oleogel-S10 appllcation won't go through advisory committee
- Amryt Pharma PLC (NASDAQ:AMYT LON:AMYT) said the US Food and Drug Administration had confirmed its New Drug Application (NDA) for Oleogel-S10 does not require an Advisory Committee meeting. Oleogel-S10 was developed to treat junctional and dystrophic epidermolysis bullosa (EB), where the skin is fragile to even the lightest touch.
- 06/07/2021
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FDA confirms NDA for Oleogel-S10 will not require an Advisory Committee Meeting
- FDA confirms NDA for Oleogel-S10 will not require an Advisory Committee Meeting
- 06/07/2021
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Amryt (AMYT) NDA for Skin Disorder Drug Gets Priority Review
- Amryt (AMYT) is seeking approval for Oleogel-S10 as a potential treatment for patients with rare and distressing genetic skin disorder, epidermolysis bullosa.
- 06/04/2021
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Amryt Pharma's Oleogel-S10 Application Gets FDA Priority Review Tag for Skin Blistering Disorder
- The FDA has granted priority review status to Amryt Pharma's (NASDAQ: AMYT) marketing application seeking approval for Oleogel-S10 to treat Epidermolysis Bullosa (EB). Oleogel-S10 is a potential treatment for the cutaneous manifestations of Junctional and Dystrophic EB, a rare genetic skin disorder characterized by blistering lesions on the skin and mucous membranes.
- 06/03/2021
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Amryt Pharma new drug application for rare skin condition fast-tracked by US Food & Drug Administration
- Amryt Pharma PLC (NASDAQ:AMYT; AIM:AMYT) was granted a priority review of its new drug application for Oleogel-S10 by the US Food & Drug Administration with a decision expected on or before November 30. The watchdog's fast-track has shortened the regulatory timeline from 10 months to six.
- 06/03/2021
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Amryt Pharma new drug application for rare skin condition fast-tracked by the US Food & Drug Administration
- Amryt Pharma PLC (NASDAQ:AMYT; AIM:AMYT) has been granted a priority review of its new drug application for Oleogel-S10 by the US drugs watchdog with a decision expected on or before November 30. The US Food & Drug Administration fast-track has shortened the regulatory timeline from 10 months to six.
- 06/03/2021
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FDA Grants Priority Review for New Drug Application for Oleogel-S10 for the Treatment of Epidermolysis Bullosa
- FDA Grants Priority Review for New Drug Application for Oleogel-S10 for the Treatment of Epidermolysis Bullosa
- 06/03/2021
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Amryt Pharma advancing on multiple fronts
- What the company does Amryt Pharma PLC (LON:AMYT) sells and develops orphan drugs used to treat rare diseases with two products on the market. Last year, Amryt acquired US group Aegerion Pharmaceuticals out of Chapter 11 bankruptcy protection in a transaction backed by convertible bondholders, creditors and Nasdaq-listed Novelion Therapeutics, Aegerion's parent company.
- 06/02/2021
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Amryt Pharma gets FDA approval for new drug application
- Amryt Pharma PLC's (NASDAQ:AMYT, LON:AMYT) new drug application for its potential treatment for epidermolysis bullosa (EB) has been approved by the US regulator. The Food and Drug Administration (FDA) accepted Amrty's application for Oleogel-S10 to be approved as a treatment for cutaneous manifestations of junctional and dystrophic EB, which affects adults and young children and for which there is no currently approved treatment.
- 06/02/2021
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Amryt Pharma plc (AMYT) Amryt Pharma Acquisition of Chiasma Inc. and Q1 2021 Earnings Conference (Transcript)
- Amryt Pharma plc (AMYT) Amryt Pharma Acquisition of Chiasma Inc. and Q1 2021 Earnings Conference (Transcript)
- 05/08/2021
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ALERT: Rowley Law PLLC is Investigating Proposed Acquisition of Chiasma, Inc.
- NEW YORK, May 5, 2021 /PRNewswire/ -- Rowley Law PLLC is investigating potential securities law violations by Chiasma, Inc. (NASDAQ: CHMA) and its board of directors concerning the proposed acquisition of the company by Amryt (NASDAQ: AMYT). Stockholders will receive 0.396 Amryt American Depository Shares for each share of Chiasma stock that they hold.
- 05/05/2021
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Amryt Reports Record Q1 2021 Financial and Operating Results
- A mryt R e ports Record Q1 2021 Financial and Operating Results
- 05/05/2021
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Amryt Announces the Appointment of Sheila Frame as President Americas
- DUBLIN, Ireland, and Boston MA, April 6, 2021, Amryt (Nasdaq: AMYT, AIM: AMYT), a global, commercial-stage biopharmaceutical company dedicated to acquiring, developing and commercializing novel treatments for rare diseases, is pleased to announce the appointment of Sheila Frame as President Americas. Sheila will lead all aspects of product commercialization for Amryt in the Americas. Sheila has held senior leadership roles across several specialty areas with Novartis, Bristol-Myers Squibb, UCB, and AstraZeneca and has worked and lived in North America and in Europe. Sheila holds an MBA from Concordia University.
- 04/06/2021
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Amryt Pharma hopeful of winning fast-track US approval for breakthrough skin gel
- Amryt Pharma PLC (NASDAQ:AMYT, LON:AMYT) said it hopes its gel designed to treat a rare skin disease will win fast-track approval from the US Food & Drug Administration after finishing the rolling completion process. Its new drug application (NDA) for Oleogel-S10 could be reviewed in just six months under an expedited protocol that aims to bring through new products for rare ailments such as junctional and dystrophic epidermolysis bullosa (EB).
- 03/31/2021
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Amryt Pharma completes FDA submission process for breakthrough skin gel; applies for expedited approval
- Amryt Pharma PLC (NASDAQ:AMYT, LON:AMYT) said has completed the rolling submission process that it hopes will end with the fast-track sign-off by the US Food & Drug Administration for its gel to treat a rare and distressing skin disease. Its new drug application (NDA) for Oleogel-S10 could be reviewed in just six months under an expedited protocol that aims to bring through new products for rare ailments such as junctional and dystrophic epidermolysis bullosa (EB).
- 03/31/2021
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Amryt Submits a New Drug Application to the US Food and Drug Administration for Oleogel-S10* (Filsuvez®)
- DUBLIN, Ireland, and Boston MA, March 31, 2021, Amryt (Nasdaq: AMYT, AIM: AMYT), a global, commercial-stage biopharmaceutical company dedicated to acquiring, developing and commercializing novel treatments for rare diseases, today announces the completion of the rolling submission of a New Drug Application (“NDA”) to the U.S. Food and Drugs Administration (“FDA”) for Oleogel-S10 for the potential treatment of cutaneous manifestations of Junctional and Dystrophic Epidermolysis Bullosa (“EB”). EB is a rare and distressing genetic skin disorder affecting young children and adults for which there is currently no approved treatment.
- 03/31/2021
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Amryt Pharma encouraged by study of lomitapide in Familial Chylomicronaemia Syndrome
- Amryt Pharma PLC (NASDAQ:AMYT, LON:AMYT) said it was ‘encouraged' by data from an investigator-sponsored study of lomitapide in Familial Chylomicronaemia Syndrome (FCS). Expert lipidologists in Italy administered the drug, also known as Juxtapid, or Lojuxta, to 18 people with the genetic disease, which results in elevated triglyceride levels, and brings with it “significant risk and disease burden”.
- 03/30/2021
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Amryt Pharma encouraged by data from investigator-sponsored study assessment of lomitapide in Familial Chylomicronaemia Syndrome
- Amryt Pharma PLC (NASDAQ:AMYT, LON:AMYT) said it was ‘encouraged' by data from an investigator-sponsored study of lomitapide in Familial Chylomicronaemia Syndrome (FCS). Expert lipidologists in Italy administered the drug, also known as Juxtapid, or Lojuxta, to 18 people with the genetic disease, which results in elevated triglyceride levels, and brings with it “significant risk and disease burden”.
- 03/30/2021
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Amryt Pharma's skin disorder treatment approved for EU regulatory review process
- Amryt Pharma PLC (LON:AMYT, NASDAQ:AMYT) said the European Union regulator will now begin the formal review process for its potential treatment for a rare genetic skin disorder with no currently approved treatment. The European Medicines Agency (EMA) has validated the marketing authorization application for the company's Oleogel-S10 for the potential treatment of cutaneous manifestations of junctional and dystrophic epidermolysis bullosa in young children and adults.
- 03/29/2021
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Amryt Announces Validation of its MAA by the EMA for Oleogel-S10* (Filsuvez®)
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Amryt Pharma receives positive feedback from the US Food & Drug Administration regarding Myalept
- Amryt Pharma PLC (LON:AMYT, NASDAQ:AMYT) said it has received positive feedback from the American drug regulator as it seeks sign-off for its Myalept drug for use in patients with partial lipodystrophy (abnormal distribution of fat). In the US, it is currently used to treat complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy.
- 03/23/2021
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Amryt Receives Positive Feedback from the FDA on the Path Forward for Myalept® (metreleptin) Indication in Partial Lipodystrophy
- Amryt Receives Positive Feedback from the FDA on the Path Forward for Myalept® (metreleptin) Indication in Partial Lipodystrophy
- 03/23/2021
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Amryt Pharma says it will receive reimbursement for Myalepta in France
- Rare diseases specialist Amryt Pharma PLC (NASDAQ:AMYT, LON:AMYT) said the French authorities have signed off its drug Myalepta for reimbursement. The Ministry of Social Affairs and Health said it will pay for the use of the treatment as an adjunct to diet for those with leptin deficiency with congenital or acquired general lipodystrophy (abnormal fat distribution in the body).
- 03/22/2021
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Amryt Receives Reimbursement Approval from the French Ministry of Social Affairs and Health for Myalepta® (metreleptin)
- Amryt Receives Reimbursement Approval from the French Ministry of Social Affairs and Health for Myalepta® (metreleptin)
- 03/22/2021
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Director/PDMR Shareholding
- Amryt Pharma plc
- 03/15/2021
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Exercise of Options and Total Voting Rights
- Exercise of Options and Total Voting Rights
- 03/12/2021
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Exercise of Warrants & Issue of Ordinary Shares and Total Voting Rights
- Exercise of Warrants & Issue of Ordinary Shares and Total Voting Rights
- 03/11/2021
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Director/PDMR Shareholding
- Grant of Options and Notification of Transactions by Persons Discharging Managerial Responsibilities
- 03/08/2021
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Amryt Pharma inks Canada distribution agreement for Myalepta drug
- Amryt Pharma PLC (NASDAQ:AMYT, LON:AMYT) said it has signed an agreement with Medison Pharma Canada, which will distribute the former's Myalepta drug in the country. It completes the multi-regional distribution deal with Medison announced in February for two products, the other being Lojuxta/Juxtapid.
- 03/08/2021
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Amryt and Medison Pharma Sign Distribution Agreement for Myalepta® (metreleptin) in Canada
- Amryt and Medison Pharma Sign Distribution Agreement for Myalepta® (metreleptin) in Canada
- 03/08/2021
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Amryt Pharma eyes further growth for 2021 after year of positive cash generation
- Amryt Pharma PLC (LON:AMYT, NASDAQ:AMYT) said it expects to continue strong sales growth for 2021 after reporting a first underlying profit and strong cash flow for the past year. The biopharma company, which acquires, develops and commercialises novel treatments for rare diseases, generated revenue growth of 18.5% to US$182.6mln for 2020 from its two products on the market, metreleptin as a supplement for people with leptin deficiency and lomitapide, for adults with a rare cholesterol disorder.
- 03/04/2021
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Amryt to Announce Q4 and FY 2020 Results on Thursday March 4, 2021
- Amryt to Announce Q4 and FY 2020 Results on Thursday March 4, 2021
- 02/24/2021
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Amryt and Medison Pharma Sign Multi-Regional Distribution Agreements in Canada and Israel
- Amryt and Medison Pharma Sign Multi-Regional Distribution Agreements in Canada and Israel
- 02/04/2021
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Amryt Receives Reimbursement Approval from NICE for Myalepta® (metreleptin) in England and Wales
- Amryt Receives Reimbursement Approval from NICE for Myalepta® (metreleptin) in England and Wales
- 01/20/2021
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Amryt Granted Orphan Drug Designation by the FDA for AP103
- Amryt Granted Orphan Drug Designation by the FDA for AP103
- 12/23/2020
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Amryt Receives Ministry of Health Reimbursement Approval for Lojuxta® (lomitapide) in Saudi Arabia
- Amryt Receives Ministry of Health Reimbursement Approval for Lojuxta® (lomitapide) in Saudi Arabia
- 12/17/2020
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Holding(s) in Company
- TR-1: S tandard form for notification of major holdings
- 12/11/2020
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Holding(s) in Company
- TR-1: S tandard form for notification of major holdings
- 12/09/2020
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Amryt Group Receives Marketing Authorisation Approval for Lojuxta® in Brazil
- Amryt Group Receives Marketing Authorisation Approval for Lojuxta® in Brazil
- 12/09/2020
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Amryt Announces $40m Private Placement with Leading Biotech Investors
- Amryt Announces $40m Private Placement with Leading Biotech Investors
- 12/08/2020
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Amryt Reports Record Q3 2020 Results - Raising FY 2020 Revenue Guidance
- AMRYT REPORTS RECORD Q3 2020 RESULTS
- 11/05/2020
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AMRYT ANNOUNCES POSITIVE RESULTS FROM PHASE 3 TRIAL OF FILSUVEZ® IN EPIDERMOLYSIS BULLOSA
- AMRYT ANNOUNCES POSITIVE RESULTS FROM PHASE 3 TRIAL OF FILSUVEZ® IN EPIDERMOLYSIS BULLOSA
- 10/29/2020
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AMRYT PHARMA NOTIFICATION OF CANCELLATION OF ADMISSION TO EURONEXT GROWTH
- AMRYT PHARMA PLC(“Amryt” or the “Company”)NOTIFICATION OF CANCELLATION OF ADMISSION TO EURONEXT GROWTHDUBLIN, Ireland, and Boston MA, August 11, 2020, Amryt, (Nasdaq: AMYT, AIM: AMYT, Euronext Growth: AYP), a global, commercial-stage biopharmaceutical company dedicated to developing and commercializing novel therapeutics to treat patients suffering from serious and life-threatening rare diseases, today announces that it has given Euronext Dublin (“Euronext”) notice of its intention to cancel the admission of the Company’s Ordinary Shares (‘Ordinary Shares”) to trading on the Euronext Growth Market ("Cancellation"). The last day of trading in Ordinary Shares on the Euronext Growth Market will be September 8, 2020 and the Cancellation will take effect at 7.00 a.m. on September 9, 2020.The Cancellation applies only to the Euronext Growth Market and will have no effect on the company’s American Depositary Shares (“ADSs”) which trade on the NASDAQ Global Select Market (“NASDAQ”) under the symbol AMYT or on Amryt’s Ordinary Shares trading on the AIM market of the London Stock Exchange.EnquiriesAmryt Pharma plc+353 (1) 518 0200 Joe Wiley, CEO Rory Nealon, CFO/COO LifeSci Advisors, LLC+1 (212) 915 2564 Tim McCarthy Consilium Strategic Communications+44 (0) 20 3709 5700 Amber Fennell, Matthew Neal, Ashley Tapp About AmrytAmryt is a biopharmaceutical company focused on developing and delivering innovative new treatments to help improve the lives of patients with rare and orphan diseases. Amryt comprises a strong and growing portfolio of commercial and development assets.Amryt’s commercial business comprises two orphan disease products.Juxtapid®/ Lojuxta® (lomitapide) is approved as an adjunct to a low-fat diet and other lipid-lowering medicinal products for adults with the rare cholesterol disorder, Homozygous Familial Hypercholesterolaemia ("HoFH") in the US, Canada, Columbia, Argentina and Japan (under the trade name Juxtapid®) and in the EU (under the trade name Lojuxta®). HoFH is a rare genetic disorder which impairs the body's ability to remove low density lipoprotein ("LDL") cholesterol ("bad" cholesterol) from the blood, typically leading to abnormally high blood LDL cholesterol levels in the body from before birth - often ten times more than people without HoFH - and subsequent aggressive and premature cardiovascular disease.Myalept® / Myalepta® (metreleptin) is approved in the US (under the trade name Myalept®) as an adjunct to diet as replacement therapy to treat the complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy (GL) and in the EU (under the trade name Myalepta®) for the treatment of leptin deficiency in patients with congenital or acquired GL in adults and children two years of age and above and familial or acquired partial lipodystrophy (PL) in adults and children 12 years of age and above for whom standard treatments have failed to achieve adequate metabolic control. Metreleptin is also approved for lipodystrophy in Japan. Generalised and partial lipodystrophy are rare disorders characterised by loss or lack of adipose tissue resulting in the deficiency of the hormone leptin, produced by fat cells and are associated with severe metabolic abnormalities including severe insulin resistance, diabetes, hypertriglyceridemia and fatty liver disease.Amryt's lead development candidate, FILSUVEZ® is a potential treatment for the cutaneous manifestations of Epidermolysis Bullosa ("EB"), a rare and distressing genetic skin disorder affecting young children and adults for which there is currently no approved treatment. FILSUVEZ® has been granted Rare Pediatric Disease Designation and has also received a Fast Track Designation from the U.S. Food and Drug Administration. The European and US market opportunity for EB is estimated by the Company to be in excess of $1.0 billion.In March 2018, Amryt in-licenced a pre-clinical gene-therapy platform technology, AP103, which offers a potential treatment for patients with Recessive Dystrophic Epidermolysis Bullosa, a subset of EB, and is also potentially relevant to other genetic disorders. For more information on Amryt, including products, please visit www.amrytpharma.com.This announcement contains inside information for the purposes of article 7 of the Market Abuse Regulation (EU) 596/2014.The person making this notification on behalf of Amryt is Rory Nealon, CFO/COO and Company Secretary.Financial Advisors Shore Capital (Edward Mansfield, Daniel Bush, John More) are NOMAD and Joint Broker to Amryt in the UK. Stifel (Ben Maddison) are Joint Broker to the company in the UK. Davy (John Frain, Daragh O’Reilly) act as Euronext Growth advisor and Joint Broker to the company in Dublin.Forward-Looking Statements Statements in this announcement with respect to Amryt's business, strategies, timing for completion of and announcing results from the EASE study, the potential impact of closing enrollment in the EASE study, as well as other statements that are not historical facts are forward-looking statements involving risks and uncertainties which could cause the actual results to differ materially from such statements. Statements containing the words "expect", "anticipate", "intends", "plan", "estimate", "aim", "forecast", "project" and similar expressions (or their negative) identify certain of these forward-looking statements. The forward-looking statements in this announcement are based on numerous assumptions and Amryt's present and future business strategies and the environment in which Amryt expects to operate in the future. Forward-looking statements involve inherent known and unknown risks, uncertainties and contingencies because they relate to events and depend on circumstances that may or may not occur in the future and may cause the actual results, performance or achievements to be materially different from those expressed or implied by such forward-looking statements. These statements are not guarantees of future performance or the ability to identify and consummate investments. Many of these risks and uncertainties relate to factors that are beyond each of Amryt's ability to control or estimate precisely, such as future market conditions, the course of the COVID-19 pandemic, currency fluctuations, the behaviour of other market participants, the outcome of clinical trials, the actions of regulators and other factors such as Amryt's ability to obtain financing, changes in the political, social and regulatory framework in which Amryt operates or in economic, technological or consumer trends or conditions. Past performance should not be taken as an indication or guarantee of future results, and no representation or warranty, express or implied, is made regarding future performance. No person is under any obligation to update or keep current the information contained in this announcement or to provide the recipient of it with access to any additional relevant information that may arise in connection with it. Such forward-looking statements reflect the Company’s current beliefs and assumptions and are based on information currently available to management.
- 08/11/2020
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AMRYT ANNOUNCES Q2 2020 RESULTS AND ISSUES POSITIVE REVENUE GUIDANCE FOR FY 2020
- AMRYT ANNOUNCES Q2 2020 RESULTS AND ISSUES POSITIVE REVENUE GUIDANCE FOR FY 2020New revenue guidance of $170M - $175M in 2020Conference call and webcast today 0830 ET / 1330 BSTDUBLIN, Ireland, and Boston MA, August 6, 2020, Amryt (Nasdaq: AMYT, AIM: AMYT, Euronext Growth: AYP), a global, commercial-stage biopharmaceutical company dedicated to developing and commercializing novel therapeutics to treat patients suffering from serious and life-threatening rare diseases, today announces unaudited financial results and provides a business update for the second quarter ended June 30, 2020. * 22% YoY growth in unaudited Q2 revenues to $46.2M (Q2 20191 unaudited combined revenues: $37.9M) * 26% YoY increase in unaudited H1 revenues to $90.8M (H1 20191 unaudited combined revenues: $72.3M) * 4% QoQ unaudited revenue growth in Q2 versus Q1 ($44.6M). 9% growth QoQ excluding the impact of irregular orders in Q1 and Q2 * $12.0M operating loss before finance expense in Q2. Excluding non-cash items and share based compensation expenses, this resulted in EBITDA2 of $6.9M in Q2 representing 50% QoQ growth and delivering $11.5M EBITDA2 for H1 * Strong cash generation during H1 with $9.7M of cash generated from operating activities * Robust financial position with $67.0M in unrestricted cash at June 30, 2020 * Issuing FY 2020 revenue guidance of between $170M and $175M (20191: $154.1m) * On July 8, 2020, Amryt listed on the Nasdaq Global Select Market (“Nasdaq”)Joe Wiley, CEO of Amryt Pharma, commented: “The very positive momentum we experienced during 2019 and Q1 this year has been maintained through Q2 and I am pleased to report that our business continues to perform and grow beyond our expectations, notwithstanding the obvious challenges we have faced in working through the very different environment presented by the COVID-19 pandemic. Our primary focus remains the health and well-being of our team, patients, carers, partners and their families.Our two commercial products, metreleptin and lomitapide continue to deliver growth across a host of metrics including revenue and EBITDA growth, cash generation and market expansion. We have had in place for some time, the management team, systems and infrastructure to support and scale the growth of our global business.Our exciting development pipeline of new therapeutic drug candidates for diseases where there is a high unmet medical need continues to progress in line with our expectations. In particular, we look forward to announcing top-line data from our EASE Phase 3 global clinical trial in late Q3 / early Q4. Despite the uncertainties brought about by COVID-19, we believe we have good visibility on our commercial business in the second half of the year. Our confidence in the stability and prospects for our business is illustrated today as we are issuing formal and positive guidance to the market for FY 2020 revenues.”Q2 and Recent Business Highlights: * In June 2020, Amryt publicly filed a Registration statement on Form F-1 with the U.S. Securities and Exchange Commission ("SEC") relating to the listing of American Depositary Shares ("ADSs") on Nasdaq. Amryt’s ADSs began trading on Nasdaq on July 8, 2020 under the symbol AMYT * Amryt signed a distribution agreement for Myalepta® with Swixx BioPharma AG (“Swixx”) across 17 jurisdictions in Central and Eastern Europe in June 2020 * EASE, Amryt’s global pivotal Phase 3 trial in patients with dystrophic and junctional Epidermolysis Bullosa (“EB”), closed enrolment in April and is on track for top-line data readout in late Q3 / early Q4 2020Q2 Financial Highlights: Revenues * $46.2M unaudited Q2 revenues representing a 22% increase on unaudited combined revenues of $37.9M in Q2 20191 * 4% quarter on quarter unaudited revenue growth in Q2 2020 versus Q1 2020 ($44.6M). 9% growth quarter on quarter excluding the impact of irregular orders in Q1 and Q2 * 33% growth in Myalept® / Myalepta® (metreleptin) revenues to $27.9M in the quarter (Q2 2019: unaudited combined revenues1 $20.9M). Metreleptin revenues were bolstered by a $1.1M order which typically occurs once annually * 8% increase in Juxtapid®/Lojuxta® (lomitapide) revenues to $18.1M in the quarter (Q2 2019: unaudited combined revenues1 $16.8M) * US revenues accounted for 52% of total global revenues in Q2 * EMEA revenues accounted for 38% of global revenues, driven by the continued rollout of metreleptin post European Medicines Agency (“EMA”) approval in 2018. Q2 revenues for EMEA were favourably impacted by seasonal patterns and by forward ordering in certain jurisdictions driven by the COVID-19 pandemic1 Unaudited combined revenues for 2019 represent the combined unaudited revenues of the Company assuming the acquisition by Amryt of Aegerion happened on 1 January 2019. It also (i) excludes revenues from sales to end-users in Japan following the out-licencing of Juxtapid to Recordati in February 2019, (ii) excludes up-front payments from Recordati in 2019, and (iii) includes a 22.5% royalty on Japanese sales of Juxtapid from 1 January 2019 as if the Recordati agreement was in place from that date.Statutory and adjusted Q2 results:US$MQ2 2019 (unaudited)Q2 2020 (unaudited)Q2 2020 Non-cash Items3Q2 2020 Non-GAAP Adjusted Revenue4.646.2-46.2 Gross profit2.816.717.634.3 R&D(3.7)(6.2)-(6.2) SG&A(6.1)(21.6)0.5(21.1) Acquisition & severance related costs(2.6)(0.1)-(0.1) Share based compensation expenses(0.1)(0.8)0.8- Operating (loss) / profit before finance expense(9.7)(12.0)18.96.9 2 Unrestricted cash & cash equiv.5.367.0-67.0 2 EBITDA is earnings before interest, tax, depreciation, amorstisation and share based compensation expenses. To supplement Amryt's financial results presented in accordance with IFRS generally accepted accounting principles, the Company uses EBITDA as a key measure of company performance as the Company believes that this measure is most reflective of the operational profitability or loss of the Company and provides management and investors with useful supplementary information which can enhance their ability to evaluate the operating performance of the business. EBITDA, as measured by the Company, is not meant to be considered in isolation or as a substitute to operating profit / loss attributable to Amryt and should be read in conjunction with the Company's condensed consolidated financial statements prepared in accordance with IFRS.3 Non-cash items include amortisation of the acquired metreleptin and lomitapide intangible assets ($11.1M), amortisation of the inventory fair value step-up that was acquired at the acquisition date ($6.5M), depreciation ($0.5M) and share based compensation expenses ($0.8M).The Q2 operating loss of $12.0M includes the impact of non-cash items including amortisation, depreciation and the impact of share-based compensation expenses. Adjusting for these non-cash items, the Company delivered $6.9M of EBITDA2 for the quarter. R&D expenses decreased to $6.2M in Q2 (Q1: $8.9M). SG&A expenses increased in Q2 to $21.6M (Q1: $18.4M).Financial Position:Cash generated from operating activities in Q2 was $3.5M. During the quarter, the Company paid $4.0M in net finance payments, $4.2M in residual payments related to legacy fines levied on Aegerion and $0.1M in capital expenditure. The legacy fines will be fully discharged by the end of Q1 2021. At June 30, 2020, the Company had unrestricted cash and cash equivalents of $67.0M (unaudited), compared to unrestricted cash and cash equivalents at December 31, 2019 of $65.2M (audited).Financial Guidance and Outlook:Revenues for the FY 2020 are expected to be in the range $170M - $175M. This forecast takes into account the seasonality and forward-ordering patterns already identified in Q2 and the impact of variable orders in H1.Webcast and Conference Call:Management will host a webcast for analysts and investors today at 0830 ET / 1330 BST. Webcast Player URL: https://edge.media-server.com/mmc/p/7ujspsgkTelephone Dial in details: Standard International Number+44 (0) 203 009 5709 United States+1 646 787 1226 United Kingdom (Local)+44 (0) 844 493 6766 Ireland\+ 353 (1) 506 0626 Confirmation Code7674874 A playback facility will be available from August 6, 2020 at 1330 ET / 1830 BST – August 13, 2020 at 1330 ET / 1830 BST. Access details as follows: Confirmation Code: 7674874 | US: + 1 917 677 7532 | UK/International: +44 (0) 3333 00 9785 | Ireland: +353 (1) 553 8777.Enquiries: Amryt Pharma plc+353 (1) 518 0200 Joe Wiley, CEO Rory Nealon, CFO/COO LifeSci Advisors, LLC+1 (212) 915 2564 Tim McCarthy Consilium Strategic Communications+44 (0) 20 3709 5700 Amber Fennell, Matthew Neal, Ashley Tapp About AmrytAmryt is a biopharmaceutical company focused on developing and delivering innovative new treatments to help improve the lives of patients with rare and orphan diseases. Amryt comprises a strong and growing portfolio of commercial and development assets.Amryt’s commercial business comprises two orphan disease products.Juxtapid®/ Lojuxta® (lomitapide) is approved as an adjunct to a low-fat diet and other lipid-lowering medicinal products for adults with the rare cholesterol disorder, Homozygous Familial Hypercholesterolaemia ("HoFH") in the US, Canada, Columbia, Argentina and Japan (under the trade name Juxtapid®) and in the EU (under the trade name Lojuxta®).
- 08/06/2020
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These 2 Small-Cap Stocks Could See 50%-Plus Gains, Says Canaccord
- In this time of pandemic, stock markets have mostly been – rising. Yes, we had a crash in February/March, part of that initial ‘panic mode’ when Federal, state, and local governments shut down economic activity and ordered social lockdown policies, but that turned around at the end of March. We’ve had a bullish rally since then. The S&P 500 stands just above 3,200, only 4.5% below its all-time peak.With this in mind, Canaccord's Chief US Strategist Tony Dwyer looked at some historical data, and found that when over 90% of the S&P 500 components trade above their 50-day moving averages for at least ten straight days, the market usually moves sideways for multiple weeks, with the trend sometimes persisting for up to three months.“Ultimately, such consolidation periods following these breadth-thrust ramps studied take place early in a new bull market and are resolved to the upside. Our tactical game plan since June 5 has been to add risk when the market moves back down to SPX 3000, and we have used the two opportunities to do just that,” Dwyer noted.Using Dwyer’s strategy to provide concrete recommendations, Canaccord’s top analysts have honed in on two small-caps, stocks with market caps of less than $400 million, poised to post big gains in the coming months. After running the tickers through TipRanks’ database, it’s clear the names are also getting support from the rest of the Street.CRH Medical Corporation (CRHM)Serving the Gastroenterology (GI) community, CRH Medical provides physicians with a wide range of products designed to improve the procedural experience. The company, which sports a market cap of only $166 million and $2.30 share price, has earned Canaccord’s praise thanks to its impressive pipeline and strong M&A strategy.Representing the firm, 5-star analyst Richard Close points out that company has been making headway on the acquisition front. Throughout the pandemic, management has been continuing discussions with M&A targets.“The pipeline has actually grown during this time given that more GI's had free time due to reduced volume and were available to discuss M&A opportunities. We believe this could bode well for an acceleration of deals in 2021,” Close noted.Speaking to these efforts, three purchases were made by the company during COVID. Along with the acquisition of a 75% stake in Lake Lanier Anesthesia Associates, which could see annualized revenue of $2.7 million, and its start-up joint venture with a 51% ownership in Oconee River Anesthesia Associates, CRHM revealed it had snapped up a 75% stake in Metro Orlando Anesthesia Associates, a company that provides services to one ASC in Orlando. Metro Orlando Anesthesia is set to generate $1.9 million in annualized revenue.Weighing in on these buys, Close commented, “We did not expect the company to resume acquisitions so quickly, having already completed three transactions in June. We are encouraged by the company's quick rebound and now have a positive outlook for our 2020E forecasts considering we had no acquisitions forecasted in our model for the rest of 2020.”Reflecting another positive, the company is pursuing contracted status for those payer relationships that are currently non-contracted, and even though the crisis delayed these discussions, CRHM remains committed to pushing for on-contract rates. “Getting through this process will remove an overhang on the stock that has created variability in results over the last several years,” Close stated.In line with his optimistic take, Close rates CRHM a Buy along with a $3.50 price target. A twelve-month gain of 52% could be in store, should the analyst’s thesis play out in the year ahead. (To watch Close’s track record, click here) Similarly, the rest of the Street is getting onboard. 4 Buy ratings and 1 Hold assigned in the last three months add up to a Strong Buy analyst consensus. In addition, the $3.37 average price target puts the potential gain at 46%. (See CRHM stock analysis on TipRanks)Amryt Pharma (AMYT)Boasting a market cap of $364.9 million, Amryt Pharma develops therapies that could potentially improve the lives of patients with rare, debilitating conditions. With operational tailwinds set to propel it forward, it’s no wonder Canaccord gave it a thumbs up.5-star analyst Michelle Gilson points to AMYT’s expanding base business as being a key component of her bullish thesis. She highlights that lomitapide, which is approved in the U.S. and EU for homozygous familial hypercholesterolemia (HoFH), drove revenues of $45 million in Q1 2020 and metreleptinm, its asset for generalized lipodystrophy (GL) and partial lipodystrophy (PL), generated $157 million in 2019. It should also be noted that AMYT achieved adjusted EBITDA profitability and cash flow positivity in Q1, demonstrating the build-out of a more efficient infrastructure following the acquisition of Aegerion has been effective, in the analyst’s opinion.“With a strengthened B/S to support the new business model (reduced debt burden, increased cash with equity raise), the Amryt team has been able to focus on and invest in the EU launch of metreleptin and re-establishment of medical affairs to reduce unnecessary discontinuations, which should support continued organic growth,” Gilson explained.In addition, the company has placed a significant focus on expanding the labels for these two drugs. Gilson told clients, “Studies are underway/planned for metreleptin in PL (U.S.), lomitapide in familial chylomicronemia syndrome (FCS), and lomitapide in pediatric HoFH... If successful, these indications could double the market opportunity in the US for metreleptin and WW for lomitapide.”When it comes to Filsuvez (AP101), its topical therapeutic designed for use in epidermolysis bullosa (EB), Gilson also sees a major opportunity. Filsuvez has already shown that it can speed up healing times in partial thickness wounds, so the analyst has high hopes ahead of the Phase 3 data readout, which is slated for late Q3 or early Q4. As such, this event could be an important near-term catalyst. If that wasn’t enough, the company’s pipeline includes a polymer-based, topical gene therapy platform, with the lead candidate, AP103, for dystrophic EB expected to enter clinical development in 2H21. Based on all of the above, Gilson rates AMYT a Buy rating, along with a $40 price target. This figure implies shares could soar 269% in the next year. (To watch Gilson’s track record, click here)AMYT has stayed relatively under-the-radar, with its Moderate Buy consensus rating breaking down into 2 Buys and no Holds or Sells. At $42.50, the average price target indicates upside potential in the shape of a whopping 287%. (See AMYT stock analysis on TipRanks)To find good ideas for small-cap stocks trading at attractive valuations, visit TipRanks’ Best Stocks to Buy, a newly launched tool that unites all of TipRanks’ equity insights.
- 08/03/2020
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AMRYT TO HOST KEY OPINION LEADER CALL ON EPIDERMOLYSIS BULLOSA DISEASE LANDSCAPE
- AMRYT PHARMA PLC(“Amryt” or the “Company”)AMRYT TO HOST KEY OPINION LEADER CALL ON EPIDERMOLYSIS BULLOSA DISEASE LANDSCAPEMonday, August 3, 2020 at 1000 ET / 1500 BSTDUBLIN, Ireland, and Boston MA, July 29 2020, Amryt (Nasdaq: AMYT, AIM: AMYT, Euronext Growth: AYP), a global, commercial-stage biopharmaceutical company dedicated to developing and commercializing novel therapeutics to treat patients suffering from serious and life-threatening rare diseases, today announces it will host a Key Opinion Leader (KOL) call on Epidermolysis Bullosa (EB) disease on Monday, August 3, 2020 at 1000 ET (1500 BST).The call will feature a presentation by KOLs Harper Price, MD (Phoenix Children's Hospital) and Brett Kopelan (debra of America) who will discuss the current disease landscape and unmet medical need in treating patients with EB. Dr. Price and Mr. Kopelan will be available for questions at the conclusion of the event.To register for the call, please click here.Harper Price, MD completed her dermatology training at Penn State Milton S. Hershey Medical Center in Hershey, Pennsylvania, and her pediatric dermatology fellowship at New York University Medical Center, New York. She has served at Phoenix Children’s Hospital (PCH) since 2009 where she provides the latest medications and technology available for the specialized treatment of infants, children, adolescents and young adults affected by large nevi. Shortly after joining PCH, she became the program director of their pediatric dermatology fellowship. She now serves as Associate Chief of the Division of Dermatology. While a student, Dr. Price worked closely with doctors at NYU to review all the major nevus registries in existence at the time and undertook to combine all the data into a single collection. Nevus Outreach invited Dr. Price to attend and assist at the 2010 conference. Based on the strength of her work, she was invited to speak at the 2011 International Expert Meeting for Large Congenital Melanocytic Nevi and Neurocutaneous Melanocytosis in Tübingen, Germany, where she was recruited to serve as Assistant Director of a team of world experts to oversee creation of an all-new world-wide nevus patient data repository under the direction of Dr. Veronica Kinsler at Great Ormond Street Hospital in London. Dr. Price is a regular speaker at national dermatology and pediatric conferences. Her work is published in textbooks and peer-reviewed journals.Brett Kopelan was initiated into the world of rare diseases ten years ago when his daughter was born with a severe form of Recessive Dystrophic Epidermolysis Bullosa (RDEB). Shortly after her birth, Brett was elected to the board of directors of the Dystrophic Epidermolysis Bullosa Research Association of America (debra of America). Upon returning to New York City after his daughter was the 8th child in the world to undergo a stem cell transplant in hopes of treating her RDEB, he became the Executive Director of debra of America, the only national not-for-profit providing all-inclusive support to the EB community. He currently serves as: President of the board of directors of the Coalition of Skin Diseases; Treasurer on the board of directors of debra international (a consortium of 55 nongovernmental organizations dedicated to curing EB); and, Secretary on a 50-year old financial services firm’s board of directors. Brett also formerly served as both the Chairman of the board of directors, and as the treasurer of the National Organization for Rare Disorders (NORD). Prior to his rare disease work, Brett was an accomplished entrepreneur, starting three different companies raising more than $30 million in venture financing, where he led business development and marketing. He has a graduate degree from Columbia University and an undergraduate degree from New York University.Enquiries: Amryt Pharma Plc+353 (1) 518 0200 Joe Wiley, CEO Rory Nealon, CFO/COO Consilium Strategic Communications +44 (0) 20 3709 5700 Amber Fennell, Matthew Neal, Ashley Tapp LifeSci Advisors, LLC+1 (212) 915 2564 Tim McCarthy The person making this notification on behalf of Amryt is Rory Nealon, CFO/COO and Company Secretary.About AmrytAmryt is a biopharmaceutical company focused on developing and delivering innovative new treatments to help improve the lives of patients with rare and orphan diseases. Amryt comprises a strong and growing portfolio of commercial and development assets.Amryt’s commercial business comprises two orphan disease products.Juxtapid®/ Lojuxta® (lomitapide) is approved as an adjunct to a low-fat diet and other lipid-lowering medicinal products for adults with the rare cholesterol disorder, Homozygous Familial Hypercholesterolaemia ("HoFH") in the US, Canada, Columbia, Argentina and Japan (under the trade name Juxtapid®) and in the EU (under the trade name Lojuxta®). HoFH is a rare genetic disorder which impairs the body's ability to remove low density lipoprotein ("LDL") cholesterol ("bad" cholesterol) from the blood, typically leading to abnormally high blood LDL cholesterol levels in the body from before birth - often ten times more than people without HoFH - and subsequent aggressive and premature cardiovascular disease.Myalept® / Myalepta® (metreleptin) is approved in the US (under the trade name Myalept®) as an adjunct to diet as replacement therapy to treat the complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy (GL) and in the EU (under the trade name Myalepta®) for the treatment of leptin deficiency in patients with congenital or acquired GL in adults and children two years of age and above and familial or acquired partial lipodystrophy (PL) in adults and children 12 years of age and above for whom standard treatments have failed to achieve adequate metabolic control. Metreleptin is also approved for lipodystrophy in Japan. Generalised and partial lipodystrophy are rare disorders characterised by loss or lack of adipose tissue resulting in the deficiency of the hormone leptin, produced by fat cells and are associated with severe metabolic abnormalities including severe insulin resistance, diabetes, hypertriglyceridemia and fatty liver disease.Amryt's lead development candidate, FILSUVEZ® is a potential treatment for the cutaneous manifestations of Epidermolysis Bullosa ("EB"), a rare and distressing genetic skin disorder affecting young children and adults for which there is currently no approved treatment. FILSUVEZ® has been granted Rare Pediatric Disease Designation and has also received a Fast Track Designation from the FDA. The European and US market opportunity for EB is estimated by the Company to be in excess of $1.0 billion.In March 2018, Amryt in-licenced a pre-clinical gene-therapy platform technology, AP103, which offers a potential treatment for patients with Recessive Dystrophic Epidermolysis Bullosa, a subset of EB, and is also potentially relevant to other genetic disorders. For more information on Amryt, including products, please visit www.amrytpharma.com.Forward-Looking Statements Statements in this announcement with respect to Amryt's business, strategies, timing for completion of and announcing results from the EASE study, the potential impact of closing enrollment in the EASE study, as well as other statements that are not historical facts are forward-looking statements involving risks and uncertainties which could cause the actual results to differ materially from such statements. Statements containing the words "expect", "anticipate", "intends", "plan", "estimate", "aim", "forecast", "project" and similar expressions (or their negative) identify certain of these forward-looking statements. The forward-looking statements in this announcement are based on numerous assumptions and Amryt's present and future business strategies and the environment in which Amryt expects to operate in the future. Forward-looking statements involve inherent known and unknown risks, uncertainties and contingencies because they relate to events and depend on circumstances that may or may not occur in the future and may cause the actual results, performance or achievements to be materially different from those expressed or implied by such forward-looking statements. These statements are not guarantees of future performance or the ability to identify and consummate investments. Many of these risks and uncertainties relate to factors that are beyond each of Amryt's ability to control or estimate precisely, such as future market conditions, the course of the COVID-19 pandemic, currency fluctuations, the behaviour of other market participants, the outcome of clinical trials, the actions of regulators and other factors such as Amryt's ability to obtain financing, changes in the political, social and regulatory framework in which Amryt operates or in economic, technological or consumer trends or conditions. Past performance should not be taken as an indication or guarantee of future results, and no representation or warranty, express or implied, is made regarding future performance. No person is under any obligation to update or keep current the information contained in this announcement or to provide the recipient of it with access to any additional relevant information that may arise in connection with it. Such forward-looking statements reflect the Company’s current beliefs and assumptions and are based on information currently available to management.
- 07/29/2020
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AMRYT TO ANNOUNCE Q2 RESULTS ON AUGUST 6, 2020
- AMRYT PHARMA PLC (“Amryt” or the “Company”) AMRYT TO ANNOUNCE Q2 RESULTS ON AUGUST 6, 2020 DUBLIN, Ireland, and Boston MA, July 20 2020, Amryt (Nasdaq: AMYT, AIM: AMYT,.
- 07/20/2020
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