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Amryt (Nasdaq: AMYT, AIM: AMYT) announced the appointment of Sheila Frame as President Americas, effective immediately. She will oversee product commercialization in the Americas, bringing extensive experience from her previous roles at major biopharmaceutical companies. CEO Dr. Joe Wiley expressed confidence in her ability to drive Amryt's innovative therapies to patients. Amryt focuses on treatments for rare diseases and has commercial products including Myalept® and Juxtapid®.
Amryt (Nasdaq: AMYT, AIM: AMYT) has completed the rolling submission of a New Drug Application (NDA) for Oleogel-S10, aimed at treating cutaneous manifestations of Epidermolysis Bullosa (EB), a rare genetic skin disorder. This submission requests Priority Review from the FDA, potentially expediting the review process to six months. The NDA is supported by successful data from the EASE phase 3 trial, which demonstrated accelerated wound healing. Notifications regarding the NDA's acceptance are expected in Q2 2021.
Amryt (Nasdaq: AMYT) has announced positive efficacy and safety results from the investigator-sponsored study of lomitapide in patients with Familial Chylomicronaemia Syndrome (FCS). The study involved 18 adults, revealing a significant median reduction of 70.5% in fasting triglyceride levels, dropping from 1884 mg/dL to 672 mg/dL after 26 weeks. All patients completed the treatment, with adverse effects primarily being mild to moderate. Amryt plans to discuss the study results with the FDA and EMA to explore potential next steps for lomitapide.
Amryt (Nasdaq: AMYT) announces the validation of its Marketing Authorization Application (MAA) for Oleogel-S10 by the European Medicines Agency (EMA) to treat cutaneous manifestations of Junctional and Dystrophic Epidermolysis Bullosa (EB). This rare genetic disorder currently lacks an approved treatment. The EMA's validation indicates the application is ready for formal review, which will follow standard timelines. The MAA is supported by successful results from the EASE pivotal phase 3 trial, meeting its primary endpoint of accelerated wound healing.
Amryt Receives Positive FDA Feedback on Myalept® for Partial Lipodystrophy
Dublin, Ireland, and Boston MA, March 23, 2021 - Amryt (Nasdaq: AMYT) provided an update on FDA engagement regarding Myalept® (metreleptin) for treating partial lipodystrophy (PL). The FDA is open to considering an efficacy supplement based on a 6-month placebo-controlled trial. This approval could potentially double the US market opportunity for Myalept®. A 12-month Phase 3 trial will enroll approximately 80 patients, marking significant progress in addressing the needs of PL patients.
Amryt Receives Reimbursement Approval from the French Ministry of Social Affairs and Health for Myalepta® (metreleptin). This approval allows access to Myalepta® for patients suffering from leptin deficiency due to generalized and partial lipodystrophy. Myalepta®, which received EMA marketing authorization in 2018, is now reimbursed for patients aged two and older with GL and 12 and older with PL. Dr. Joe Wiley, CEO, emphasized the progress in expanding product reach. Amryt focuses on rare diseases and has a growing portfolio, including metreleptin and lomitapide.
Amryt Pharma plc announced a transaction by its Chairman, Ray Stafford, under the EU Market Abuse Regulation. On March 12, 2021, Stafford purchased 300,100 ordinary shares at a price of £2.00 per share, totaling £600,200. This transaction took place on the London Stock Exchange, AIM.
Amryt (AMYT) has issued 300,000 ordinary shares due to employee options exercised, increasing the total issued share capital to 183,593,296 shares. The company now holds 4,208,314 shares in treasury, leading to a total of 179,384,982 voting rights. This number is key for shareholders to determine their reporting obligations under the FCA’s Disclosure Guidance and Transparency Rules. Amryt specializes in innovative treatments for rare diseases, including Myalept and Juxtapid, and is developing Filsuvez for Junctional and Dystrophic Epidermolysis Bullosa.
Amryt (Nasdaq: AMYT) announced the exercise of warrants for 283,389 Ordinary Shares on March 11, 2021. This issuance follows the company's AIM Market listing in 2016, where each warrant allowed subscription at £1.44 per share. Post-issuance, Amryt's total Ordinary Shares are 183,593,296, with 4,508,314 held in treasury, resulting in total voting rights of 179,084,982. This number is crucial for shareholders to gauge their notification responsibilities under FCA regulations.
Amryt (Nasdaq: AMYT, AIM: AMYT) announced the grant of 3,431,350 share options to CEO Joe Wiley and CFO Rory Nealon, approved by the Remuneration Committee. The exercise price is set at US$2.804 per Share. Options can be exercised in increments over three years, with 25% available after 12 months. All options are subject to change of control provisions and expire seven years post-grant. Following this grant, Wiley holds 8,468,810 options and Nealon holds 6,226,823 options, reflecting their commitment to the company's growth.
