Amryt Pharma

46 articles with Amryt Pharma

• Amryt to Report Q2 2022 Results on August 4, 2022

  7/21/2022

  Amryt today announces that its unaudited financial results for the second quarter 2022 will be released on Thursday, August 4, 2022 at 0700 ET/1200 BST.

• Amryt Announces Appointment of Dr Tracy Cunningham as Chief Medical Officer

  6/27/2022

  Amryt (Nasdaq: AMYT), a global, commercial-stage biopharmaceutical company focussed on acquiring, developing and commercializing novel treatments for rare diseases, is pleased to announce the appointment of Dr Tracy Cunningham as Chief Medical officer (CMO) with immediate effect.

• Amryt to Pursue Formal Dispute Resolution for Oleogel-S10 (Filsuvez®) NDA

  6/24/2022

  Amryt today announces that the company plans to submit a Formal Dispute Resolution Request (FDRR) for the company’s New Drug Application (NDA) for Oleogel-S10 (Filsuvez®), for the treatment of the cutaneous manifestations of Dystrophic and Junctional Epidermolysis Bullosa (EB).

• 

  Amryt Pushes Back Against FDA Decision on Rare Skin Disease Treatment

  6/24/2022

  Amryt Pharma is filing a formal dispute resolution request (FDRR) with the FDA after receiving a CRL that delays the production of its drug for a rare skin disorder.

• European Commission Approves Filsuvez® for the treatment of Dystrophic and Junctional EB

  6/23/2022

  Amryt (Nasdaq: AMYT), a global, commercial-stage biopharmaceutical company focussed on acquiring, developing and commercializing novel treatments for rare diseases, is pleased to announce the European Commission (EC) approval of Filsuvez® in the European Union (EU) for the treatment of partial thickness wounds associated with dystrophic and junctional Epidermolysis Bullosa (EB) in patients 6 months and older.

• Amryt Presents Data for Mycapssa® (oral octreotide) from OPTIMAL and MPOWERED Phase 3 Trials at ENDO 2022

  6/13/2022

  Amryt Presents Data for Mycapssa® (oral octreotide) from OPTIMAL and MPOWERED Phase 3 Trials at ENDO 2022.

• Amryt to Present Data from OPTIMAL and MPOWERED Phase 3 Trials Open Label Extension of Mycapssa® (oral octreotide) at ENDO 2022

  6/8/2022

  Amryt (Nasdaq: AMYT), a global, commercial-stage biopharmaceutical company dedicated to acquiring, developing and commercializing novel treatments for rare diseases, today announced that it will be presenting positive data from two Phase 3 clinical trials: the two-year open-label extension of the OPTIMAL study and the MPOWERED study, at the Endocrine Society’s annual meeting, ENDO 2022.

• Posting of Annual Report and Notice of AGM

  6/1/2022

  Amryt announces that copies of the Company’s annual report for the year ended December 31, 2021 have been sent to Shareholders along with the Notice of Annual General Meeting.

• Amryt Announces Details of EMA Contingent Value Rights Payment

  5/17/2022

  Amryt announces that, following the CHMP positive opinion for Filsuvez® on April 22, 2022, the European Medicines Agency Contingent Value Rights issued to those Amryt shareholders and option holders who held Amryt shares or options prior to the acquisition of Aegerion Pharmaceuticals, Inc.

• Amryt Announces New Patent for Mycapssa®

  5/11/2022

  Amryt Announces New Patent for Mycapssa® .

• Amryt Reports Record Q1 2022 Results

  5/4/2022

  Amryt (Nasdaq: AMYT), a global, commercial-stage biopharmaceutical company dedicated to acquiring, developing and commercializing novel treatments for rare diseases, today provides a business update and announces unaudited financial results for the first quarter ended March 31, 2022.

• CHMP adopts positive opinion for Filsuvez® for the treatment of Dystrophic and Junctional EB

  4/22/2022

  Amryt is pleased to announce that the European Medicines Agency's Committee for Medicinal Products for Human Use has adopted a positive opinion, recommending the approval of Filsuvez® in the European Union for the treatment of partial thickness wounds associated with dystrophic and junctional Epidermolysis Bullosa in patients 6 months and older.

• Amryt to Report Q1 2022 Results on May 4, 2022

  4/14/2022

  Amryt today announces that its unaudited financial results for the first quarter 2022 will be released on Wednesday, May 4, 2022at 0700 ET/1200 BST.

• Amryt Announces Positive Long-Term Safety and Efficacy Data for Mycapssa® (oral octreotide) from the 2nd Year of OPTIMAL Open Label Extension Study in Acromegaly Patients

  4/13/2022

  Amryt (Nasdaq: AMYT), a global, commercial-stage biopharmaceutical company dedicated to acquiring, developing and commercializing novel treatments for rare diseases, today presents long-term safety and efficacy data from the 2nd year open-label extension (OLE) of its global Phase 3 OPTIMAL clinical trial that compared Mycapssa® (octreotide capsules) to placebo for maintenance of biochemical response in patients with acromegaly.

• Amryt Supports World Lipodystrophy Day - March 31, 2022

  3/31/2022

  DUBLIN, Ireland, and Boston MA, March 31, 2022, Amryt, a global, commercial-stage biopharmaceutical company focussed on acquiring, developing and commercializing novel treatments for rare diseases, is pleased to announce its support for World Lipodystrophy Day 2022 which takes place.

• Amryt Announces Positive Interim Analysis Data From Open Label Phase of EASE Phase 3 Trial in EB

  3/26/2022

  Amryt, a global, commercial-stage biopharmaceutical company dedicated to acquiring, developing and commercializing novel treatments for rare diseases, announced new positive clinical data from EASE, the largest Phase 3 trial in Epidermolysis Bullosa.

• Amryt Announces 22% growth in FY 2021 Revenues to $222.5M

  3/9/2022

  Amryt, a global, commercial-stage biopharmaceutical company dedicated to acquiring, developing and commercializing novel treatments for rare diseases, provides a business update and unaudited financial results for Q4 2021 and the full year ended December 31, 2021.

• Amryt Announces Successful Bioavailability Study for Mycapssa® (octreotide capsules)

  3/8/2022

  Amryt, a global, commercial-stage biopharmaceutical company dedicated to acquiring, developing and commercializing novel treatments for rare diseases, announces completion of a successful pharmacokinetic study for Mycapssa®.

• Results of General Meeting

  3/3/2022

  Amryt is pleased to announce that all resolutions presented to shareholders at yesterday’s General Meeting were duly passed including a resolution which approved the form of share repurchase contract and counterparties under which the Company may make repurchases of its own shares.

• 

  Amryt's Rare Skin Disease (Epidermolysis Bullosa) Treatment Rejected by FDA

  2/28/2022

  The FDA declined approval for Amryt Pharma's therapeutic oleogel-S10. The topical gel is intended to treat a group of rare skin diseases called epidermolysis bullosa.