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Amryt will present positive data from the OPTIMAL and MPOWERED Phase 3 trials of Mycapssa® (oral octreotide) at ENDO 2022 from June 11-14, 2022. The studies support Mycapssa® for treating acromegaly. The OPTIMAL trial met its primary endpoint of maintaining biochemical response, leading to US approval for Mycapssa®. The MPOWERED trial demonstrated 91% of patients maintained IGF-1 response, reinforcing Mycapssa®'s efficacy. Presentations will be held on June 12 and 13, 2022.
Amryt (Nasdaq: AMYT) announced the posting of its Annual Report for the year ending December 31, 2021, sent to shareholders along with the Notice of the Annual General Meeting (AGM). The AGM will be held on June 30, 2022, in Dublin, focusing on ensuring a COVID-secure environment. Shareholders are encouraged to vote in advance by appointing the Chairman as proxy. A listen-live facility will be available for shareholder engagement. Amryt is dedicated to developing innovative treatments for rare diseases, comprising a growing portfolio of three orphan disease products.
Amryt announces a contingent value rights payment following a positive opinion from the CHMP for Filsuvez®. The European Medicines Agency will issue approximately USD $5.7 million to CVR Holders, with each receiving USD $0.0995 per CVR. Payments will be made via cheque on September 14, 2022. The company continues to focus on developing treatments for rare diseases, enhancing its portfolio with innovative products.
Amryt Pharma announces a new patent for Mycapssa® (octreotide), following a notice of allowance from the USPTO for US Patent Application No. 17/094,238. This patent, set to expire in February 2036, adds to Amryt's portfolio of nine Orange Book-listed patents for Mycapssa® with protection extending to December 2040. CEO Dr. Joe Wiley emphasized the company's commitment to enhancing its intellectual property portfolio.
Amryt reported record Q1 2022 results, achieving 22.1% YoY revenue growth with revenues reaching $59.1M. Metreleptin revenues increased by 25.7% to $37.6M. The company reaffirmed its FY 2022 revenue guidance of $260M - $270M, indicating growth of 17%-21% over the previous year. A positive opinion for Filsuvez® was adopted by the CHMP for treating Dystrophic and Junctional EB, marking a significant milestone. The board approved a $30M stock repurchase program and reported cash reserves of $102.2M as of March 31, 2022.
Amryt received a positive opinion from the CHMP for Filsuvez®, a treatment for dystrophic and junctional Epidermolysis Bullosa (EB). This approval is based on the results of the largest global Phase 3 trial (EASE), conducted across 58 sites in 28 countries. Should the European Commission approve the application, Filsuvez® will become the only authorized treatment for EB patients in Europe. The decision is expected within 67 days. This milestone triggers the EMA Contingent Value Right (CVR) for shareholders. The global market for EB treatments is estimated to exceed $1.0 billion.
Amryt, a global biopharmaceutical company, announced it will release its Q1 2022 results on May 4, 2022, at 0700 ET/1200 BST. Following the announcement, a conference call for analysts and investors will occur at 0830 ET/1330 BST. The call can be accessed via a web broadcast, with dial-in options available for participants in the US, UK, and Ireland. Amryt focuses on developing treatments for rare diseases, with a portfolio that includes three commercial products and several candidates in development.
Amryt announced positive long-term safety and efficacy results for Mycapssa® (oral octreotide) from the second year of the OPTIMAL open-label extension study in patients with acromegaly. All evaluable patients (100%) who were responders maintained their biochemical response at the end of the study. The mean levels of IGF-1 were stable within normal limits, showing improvement in growth hormone (GH) levels as well. The long-term safety profile was consistent with previous studies, indicating no new safety concerns were observed.
Amryt Pharma (Nasdaq: AMYT) announced its support for World Lipodystrophy Day on March 31, 2022. Lipodystrophy is a rare condition leading to severe metabolic issues, with no cure currently available. The company's CEO, Dr. Joe Wiley, highlighted the importance of raising awareness to improve diagnosis and treatment. Amryt specializes in developing innovative treatments for rare diseases, with a portfolio including Myalept® and Mycapssa®. Their lead candidate, Oleogel-S10, is being developed for epidermolysis bullosa, a genetic skin disorder.
Amryt Pharmaceuticals announced positive interim analysis data from the EASE Phase 3 trial evaluating Oleogel-S10 for treating Epidermolysis Bullosa (EB). Presented at the AAD Annual Meeting 2022, the analysis showed a significant reduction in body surface area percentage of wounds—from 12.1% to 5.4%—after 15 months of treatment. The trial also met its primary endpoint with a notable improvement in wound closure rates. Importantly, no new safety signals were observed, reinforcing the treatment's viability. The global market for EB treatments is estimated to exceed $1 billion.
