Amryt Pharma

61 articles about Amryt Pharma

• Amryt Pharma Shareholders approve acquisition of Amryt Pharma by Chiesi Farmaceutici

  3/22/2023

  Amryt Pharma Shareholders approve acquisition of Amryt Pharma by Chiesi Farmaceutici.

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  Chiesi Ups Rare Disease Game with $1.48B Amryt Acquisition

  1/9/2023

  Italian biopharma Chiesi Farmaceutici SpA announced Sunday it was acquiring rare disease-focused Amryt Pharma in a deal that could reach up to $1.48 billion in value.

• Chiesi Farmaceutici S.p.A. to Acquire Amryt Pharma Plc

  1/8/2023

  Chiesi Farmaceutici S.p.A. and Amryt Pharma Plc announced that the companies have entered into a definitive agreement under which Chiesi will acquire Amryt.

• Amryt Announces Positive Top Line Results from Phase 3 Pediatric Trial of Lomitapide in HoFH

  1/5/2023

  Amryt is pleased to announce positive results from its APH-19 Phase 3 trial of lomitapide for the treatment of Homozygous Familial Hypercholesterolemia in children aged 5-17 years.

• COMP Adopts Positive Opinion on Orphan Designation for Mycapssa® for the Treatment of Carcinoid Syndrome Associated with Neuroendocrine Tumors

  12/19/2022

  Amryt (Nasdaq: AMYT), a global, commercial-stage biopharmaceutical company dedicated to acquiring, developing and commercializing novel treatments for rare diseases, today announces that the European Medicines Agency's (EMA) Committee for Orphan Medicinal Products (COMP) has adopted a positive opinion for orphan designation for the use of Mycapssa® in the treatment of carcinoid syndrome associated with neuroendocrine tumors (NET).

• European Commission approves Mycapssa® for the treatment of Acromegaly

  12/5/2022

  Amryt (Nasdaq: AMYT), a global, commercial-stage biopharmaceutical company dedicated to acquiring, developing and commercializing novel treatments for rare diseases, is pleased to announce the European Commission (EC) approval of Mycapssa® in the European Union (EU) for the maintenance treatment of acromegaly in patients who have responded to and tolerated treatment with octreotide or lanreotide.

• Amryt Announces New Patent for Mycapssa® - November 30, 2022

  11/30/2022

  Amryt announces an update regarding the patents for its product Mycapssa® (octreotide).

• Amryt Reports Q3 2022 Financial and Operational Results

  11/3/2022

  Amryt provides a business update and announces unaudited financial results for the third quarter ended September30, 2022.

• Amryt Supports Acromegaly Awareness Day 2022

  10/31/2022

  Amryt announces its support for Acromegaly Awareness Day 2022 which is taking place on November 1, 2022.

• Amryt Supports Global EB Awareness Week 2022

  10/24/2022

  \Amryt announces its support for Global Epidermolysis Bullosa Awareness Week which is taking place October 25 - 31, 2022.

• Amryt to Report Q3 2022 Results on November 3, 2022

  10/19/2022

  Amryt today announces that its unaudited financial results for the third quarter 2022 will be released on Thursday, November 3, 2022 at 0700 ET/1100 GMT.

• COMP adopts positive opinion on Orphan Disease Designation for Mycapssa® for the treatment of Acromegaly

  10/18/2022

  Amryt (Nasdaq: AMYT), a global, commercial-stage biopharmaceutical company dedicated to acquiring, developing and commercializing novel treatments for rare diseases, today announces that the European Medicines Agency's (EMA) Committee for Orphan Medicinal Products (COMP) has adopted a positive opinion, recommending that the orphan disease designation of Mycapssa® in the treatment of acromegaly in the European Union (EU) is maintained.

• Amryt Receives Reimbursement Approval from the Dutch Ministry of Health for Myalepta® (metreleptin)

  10/17/2022

  Amryt announces that the Dutch Ministry of Health has approved Myalepta® (metreleptin) for reimbursement in the Netherlands as an adjunct to diet as replacement therapy for the treatment of leptin deficiency in patients with congenital or acquired general lipodystrophy (GL) in adults and children two years of age and above.

• CHMP adopts positive opinion for Mycapssa® for the treatment of Acromegaly

  9/16/2022

  Amryt (Nasdaq: AMYT), is pleased to announce that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending the approval of Mycapssa® in the European Union (EU) for the maintenance treatment of acromegaly in patients who have responded to and tolerated treatment with octreotide or lanreotide.

• Amryt Receives Marketing Authorisation Approval and Orphan Drug Designation for Filsuvez® in Great Britain

  9/8/2022

  Amryt (Nasdaq: AMYT) today announces that the Medical Healthcare & Products Regulatory Agency (MHRA) has granted Marketing Authorisation Approval (MAA) and Orphan Disease Designation (ODD) for Filsuvez® for the treatment of partial thickness wounds associated with dystrophic and junctional Epidermolysis Bullosa (EB) in patients 6 months and older in Great Britain (GB).

• 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).

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  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.