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Amryt has released positive long-term safety and efficacy data for Mycapssa® (oral octreotide) in treating acromegaly patients. Findings from the MPOWERED Phase 3 Trial indicate that 79% of patients switching from injectable treatments to Mycapssa® reported excellent or very good symptomatic control. A median compliance rate of 99% was noted over an open-label extension period of up to 3.5 years. The long-term safety profile was consistent with previous studies, with no new safety signals. Mycapssa® is currently under evaluation for marketing authorization by the EMA.
Amryt Pharma plc has announced key dates regarding its delisting from the AIM market, effective January 11, 2022. The last day for trading its Ordinary Shares on AIM will be January 10, 2022. After this date, the company's American Depositary Shares (ADSs), each representing five Ordinary Shares, will continue trading on the Nasdaq under the ticker symbol AMYT. Shareholders are encouraged to deposit their Ordinary Shares for ADS exchange without cost before the delisting. Following the AIM Delisting, Shore Capital will cease as the company's nominated adviser.
Amryt announced positive results for the MPOWERED Phase 3 Trial of Mycapssa® (oral octreotide) in patients with acromegaly, published in The Lancet Diabetes & Endocrinology. The trial demonstrated that Mycapssa® was non-inferior to injectable somatostatin receptor ligands in maintaining biochemical control, with 91% of Mycapssa® patients maintaining response. Key endpoints noted reduced breakthrough symptoms and improved treatment satisfaction. The trial is essential for Mycapssa®'s marketing authorization application to the EMA, currently under evaluation.
Amryt has announced that as of December 31, 2021, the total issued share capital comprises 319,814,747 ordinary shares of 6 pence each, with no shares held in treasury. This number serves as the basis for shareholders calculating any required notifications under the FCA’s Disclosure Guidance and Transparency Rules. Amryt focuses on developing treatments for rare diseases, with commercial products including Myalept®, Mycapssa®, and Juxtapid®. Its lead candidate is Oleogel-S10 (Filsuvez®), under review by the FDA and EMA.
Amryt has announced that as of November 30, 2021, its issued share capital consists of 319,657,247 ordinary shares. This figure represents the total number of voting rights for shareholders, who can use it to determine if they need to notify any interest changes under the FCA’s Disclosure Guidance and Transparency Rules. Amryt focuses on developing treatments for rare diseases and has a portfolio that includes three approved orphan disease products. Amryt is monitoring regulatory developments for its lead product candidate, Oleogel-S10 (Filsuvez®).
Amryt Pharma plc announced a transaction involving shares by its Chairman, Ray Stafford. On November 29, 2021, Stafford purchased 50,000 ADSs at a price of $9.40 each, totaling $470,000. This transaction was reported in compliance with the EU Market Abuse Regulation. The shares were purchased on the NASDAQ.
Amryt has announced an extension of the FDA's review period for Oleogel-S10, a treatment for Junctional and Dystrophic Epidermolysis Bullosa (EB), by three months to February 28, 2022. This extension follows a request for additional data analyses, classified as a Major Amendment to the New Drug Application (NDA). Concurrently, EMA's opinion on Oleogel-S10 is anticipated in January 2022. Despite the delay, Amryt maintains its revenue guidance for FY 2021 at $220M - $225M, reflecting a growth of 20%-23% from FY 2020.
Amryt Pharma intends to cancel the admission of its ordinary shares to AIM, effective January 11, 2022, and will continue its listing on Nasdaq under the symbol AMYT. This decision comes as approximately 87% of trading in ordinary shares occurred via ADSs on Nasdaq. The board believes this will enhance liquidity and streamline compliance efforts. Shareholders can deposit ordinary shares for ADSs without cost before the delisting date. The change aims to better position Amryt in the international biopharmaceutical market, reducing the complexity of maintaining dual listings.
Amryt reported robust Q3 2021 results with revenues of $56.5M, reflecting a 14.6% year-over-year growth. Metreleptin revenue increased 21.5% to $36.3M, achieving 51.6% growth excluding sporadic LATAM orders. The company confirmed its FY 2021 revenue guidance of $220M - $225M, representing 20-23% growth YOY. EBITDA was positive for the seventh consecutive quarter, despite operational losses of $21.4M. Amryt continues to integrate the Chiasma acquisition and advances the regulatory pathway for Oleogel-S10, with a target PDUFA date set for November 30, 2021.
Amryt (Nasdaq: AMYT, AIM: AMYT) announced an update on its voting rights, revealing that as of October 31, 2021, its issued share capital comprises 317,999,117 ordinary shares of 6 pence each, with no shares held in treasury. This number is important for shareholders to calculate their interest notifications under the FCA’s rules. Amryt specializes in developing treatments for rare diseases, with a portfolio that includes approved products like Myalept®, Mycapssa®, and Juxtapid®, as well as a lead candidate, Oleogel-S10 (Filsuvez®), under priority review by the FDA.
