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Amryt (Nasdaq: AMYT, AIM: AMYT) announces its support for Acromegaly Awareness Day 2022 on November 1, aimed at raising awareness of this rare endocrine disorder caused by excess growth hormone. CEO Dr. Joe Wiley emphasizes the serious health impacts of acromegaly, including damage to vital organs and increased mortality. Amryt is committed to transforming the lives of those affected by rare diseases through innovative treatments. Their portfolio includes commercial products like Myalept® and Lomitapide, targeting conditions such as lipid disorders and Epidermolysis Bullosa.
Amryt has announced the publication of full results from its pivotal Phase 3 trial, EASE, for Epidermolysis Bullosa (EB), in the British Journal of Dermatology. The study demonstrated that Filsuvez® (birch bark extract) gel significantly accelerated wound healing compared to control gel, achieving a 41.3% complete wound closure rate. Other key outcomes included reduced wound burden and pain, with a similar safety profile to control. This trial contributes valuable data for a condition with significant patient impact.
Amryt (Nasdaq: AMYT, AIM: AMYT) announced its support for Global Epidermolysis Bullosa (EB) Awareness Week, scheduled for October 25-31, 2022. The company emphasizes its commitment to transforming the lives of those affected by EB, highlighting its pioneering treatment approved in the EU. CEO Dr. Joe Wiley acknowledged the challenges faced by patients and caregivers, advocating for expanded treatment options. This initiative aligns with Amryt's mission to enhance the quality of life for patients with rare diseases through innovative therapies.
Amryt, a biopharmaceutical company, will report its Q3 2022 financial results on November 3, 2022, at 7:00 ET. The company will host a conference call and webcast for analysts and investors at 8:30 ET on the same day. Amryt focuses on innovative treatments for rare diseases, offering products like Myalept, Mycapssa, Juxtapid, and Filsuvez. The company aims to improve the lives of patients with orphan diseases and is actively developing further therapeutic candidates.
Amryt announced that the European Medicines Agency's Committee for Orphan Medicinal Products (COMP) has adopted a positive opinion, recommending the continuation of the orphan disease designation for Mycapssa® in treating acromegaly in the EU. This decision follows a previous positive opinion from the Committee for Medicinal Products for Human Use (CHMP) on September 16, 2022, for Mycapssa’s approval. Mycapssa® qualifies for 10 years of market exclusivity based on its significant benefits compared to existing treatments. The recommendation is backed by data from Phase 3 studies.
Amryt Pharma has announced that the Dutch Ministry of Health has approved Myalepta® (metreleptin) for reimbursement. This treatment is designed for patients with leptin deficiency due to congenital or acquired generalized lipodystrophy (GL) aged two years and older. Myalepta®, which received EMA marketing authorization in 2018, will now be accessible to Dutch patients, marking a significant expansion for Amryt in the Netherlands. The CEO expressed optimism about this development, emphasizing its importance for patient care and the company's growth.
Amryt announces its support for FH Awareness Day on September 24, 2021, focusing on the importance of early diagnosis of Familial Hypercholesterolaemia (FH) to reduce heart disease risks. Dr. Joe Wiley, CEO, emphasized collaboration with the Family Heart Foundation to raise awareness about this often undiagnosed condition, which can lead to severe cardiovascular events. With 90% of those with FH undiagnosed, the company aims to enhance patient outcomes through education and therapy development.
Amryt has received a positive opinion from the CHMP recommending the approval of Mycapssa® for the treatment of acromegaly in the EU. This decision is based on data from the MPOWERED Phase 3 trial, indicating that 91% of patients on Mycapssa® maintained their IGF-1 response. Mycapssa® is already approved in the US and would be the first oral somatostatin analog in the EU. A decision by the European Commission is expected within 67 days.
Amryt Announces New Patent for Mycapssa®
On September 13, 2022, Amryt (Nasdaq: AMYT) announced the issuance of US Patent No. 11,400,159 by the USPTO for its product Mycapssa® (octreotide). This patent extends Mycapssa®'s protection until September 2029, part of nine Orange Book-listed patents offering protection through December 2040. CEO Dr. Joe Wiley emphasized the company's commitment to enhancing its intellectual property portfolio, highlighting the robust protection for Mycapssa®. Amryt focuses on developing novel treatments for rare diseases.
Amryt has received Marketing Authorisation Approval and Orphan Drug Designation from the UK MHRA for Filsuvez®, aimed at treating partial thickness wounds in patients with Epidermolysis Bullosa (EB).
This approval follows the European Commission's endorsement in June 2022. Amryt intends to collaborate with reimbursement agencies in the UK and EU to expedite the availability of Filsuvez®, which represents a potential market exceeding $1.0 billion globally.
