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Amryt announced the presentation of data from the MPOWERED Phase 3 trial of Mycapssa® at the ENEA 2022 Congress in France. The trial, assessing the timing of switching from injectable somatostatin receptor ligands (SRLs) to oral Mycapssa®, showed that transition timing did not affect biochemical control or symptoms associated with acromegaly. A trend towards better treatment adherence was observed when Mycapssa® was initiated within three weeks of the last SRL injection. No new safety issues were reported, and the study met its primary endpoint.
Amryt reported record Q2 2022 results, achieving 9.2% year-over-year revenue growth to $68.5 million. Excluding a prior sporadic LATAM order, revenue grew 35.3%. Metreleptin revenues rose 7.8% to $46.4 million with a 49.9% increase excluding the LATAM impact. The company generated positive EBITDA for the 10th consecutive quarter and ended Q2 with $90.7 million in cash. Filsuvez® was approved in the EU for treating dystrophic and junctional EB, with full-year revenue guidance reaffirmed at $260 million to $270 million.
Amryt, a biopharmaceutical company focusing on rare diseases, will release its Q2 2022 financial results on August 4, 2022, at 0700 ET/1200 BST. A conference call and webcast for analysts and investors will follow at 0830 ET/1330 BST. Interested parties can join via the provided webcast link.
The company is dedicated to developing innovative treatments, including four orphan disease products and related clinical candidates, supporting patients with rare conditions.
Amryt (Nasdaq: AMYT) has received Orphan Drug Designation from the FDA for Mycapssa® (oral octreotide) to treat carcinoid syndrome, a common functional syndrome linked with neuroendocrine tumors (NETs). This designation supports Amryt’s strategy to develop Mycapssa® for patients with carcinoid syndrome, providing an oral therapy option. The global market for injectable somatostatin analogs is approximately $1.9 billion, with 24,000 potential patients in the U.S. alone. A Phase 3 study is planned to begin in early 2023, aiming to further validate Mycapssa®'s efficacy.
Amryt recently presented new analyses from the EASE Phase 3 trial at the SPD 2022 annual meeting, shedding light on the efficacy of Oleogel-S10 in treating Dystrophic Epidermolysis Bullosa (DEB). Key findings include a significant reduction in procedural pain and fewer dressing changes required, highlighting improved patient outcomes. The trial demonstrated a 44.3% wound closure rate within 45 days for Oleogel-S10, compared to 29.6% for control (p=0.017). This positions Oleogel-S10 as a promising treatment option, aligning with Amryt's commitment to addressing rare diseases.
Amryt (Nasdaq: AMYT), a biopharmaceutical company, announced that all resolutions at its Annual General Meeting on July 1, 2022, were passed. The resolutions were previously detailed in the notice sent to shareholders on June 1, 2022. Amryt is focused on developing treatments for rare diseases, with a portfolio that includes key products like Myalept, Mycapssa, and Juxtapid. Additionally, the company has development candidates such as Filsuvez for epidermolysis bullosa. For more details, visit Amryt's website.
Amryt has appointed Dr. Tracy Cunningham as Chief Medical Officer effective immediately, having joined the company in April 2020 as VP, Head of Development. Dr. Cunningham brings extensive experience from leadership roles at AstraZeneca, Novartis, and GlaxoSmithKline. CEO Dr. Joe Wiley expressed confidence in her capabilities, highlighting her track record in executing development strategies. Amryt focuses on innovative treatments for rare diseases and has a robust portfolio, including three products currently on the market.
Amryt (Nasdaq: AMYT) announced plans to pursue a Formal Dispute Resolution Request (FDRR) regarding its New Drug Application (NDA) for Oleogel-S10 (Filsuvez®), intended for treating Dystrophic and Junctional Epidermolysis Bullosa (EB). Following a Type A meeting with the FDA, the company aims to address disagreements raised in a Complete Response Letter from February 2022. Filsuvez® has recently been approved by the European Commission for EB treatment, and Amryt believes data from the EASE trial supports its case for US approval.
Amryt Pharma (Nasdaq: AMYT) announced that the European Commission approved Filsuvez® for treating partial thickness wounds related to dystrophic and junctional Epidermolysis Bullosa (EB) in patients aged 6 months and older. This marks Filsuvez® as the first approved treatment for EB, a rare genetic skin disorder occurring in children and adults. The approval is based on Phase 3 data from the EASE trial, the largest global trial for EB, involving 223 patients across 58 sites in 28 countries. The centralized authorization will hold across all EU Member States and potentially facilitate future regulatory submissions in Latin America and the Middle East.
Amryt presented promising data at ENDO 2022 for Mycapssa® (oral octreotide) from the OPTIMAL and MPOWERED Phase 3 trials. The open-label extension (OLE) results demonstrated long-term safety and efficacy for acromegaly patients previously treated with injectable somatostatin receptor ligands. In the OPTIMAL trial, 100% of subjects maintained biochemical response after 96 weeks. The MPOWERED trial showed that 90% of subjects achieved primary endpoints, with significant symptom control improvements reported.
