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Amryt, a biopharmaceutical company, reported a 22% revenue growth in FY 2021, achieving $222.5M, driven by a 32% increase in metreleptin sales. The company forecasts FY 2022 revenue between $260M and $270M, indicating 17%-21% YoY growth. With a cash reserve of $113.0M as of December 31, 2021, Amryt announced a $30M stock repurchase program and its eighth consecutive quarter of positive EBITDA. A successful bioavailability study for Mycapssa® opens opportunities in the $1.9bn neuroendocrine tumor market.
Amryt has successfully completed a pharmacokinetic study for Mycapssa® (octreotide capsules), supporting a planned Phase 3 trial to treat carcinoid symptoms in patients with Neuroendocrine Tumors (NET). This study demonstrated dose linearity and an acceptable safety profile with no serious adverse events reported. The global market opportunity for NET treatments is approximately $1.9 billion, with the US market alone around $1.0 billion. The FDA has confirmed that a single positive Phase 3 study could suffice for approval.
Amryt (Nasdaq: AMYT) held a General Meeting on March 2, 2022, where shareholders approved all presented resolutions. This included the share repurchase program, allowing the company to buy back its own shares. The full resolutions were previously shared with shareholders on February 2, 2022, and are available on the company's website. Amryt specializes in developing treatments for rare diseases, with a portfolio that includes products like Myalept® and Mycapssa®. The company is focused on enhancing the lives of patients with rare conditions.
Amryt (Nasdaq: AMYT) has received a Complete Response Letter (CRL) from the FDA regarding its New Drug Application for Oleogel-S10, intended for treating Epidermolysis Bullosa (EB). The FDA stated that the application cannot be approved in its current form and requested additional confirmatory evidence of effectiveness. Amryt plans to discuss the required data with the FDA. The EB market represents a significant potential opportunity, estimated at over $1 billion globally.
Amryt supports Rare Disease Day 2022, scheduled for February 28, 2022, emphasizing the plight of approximately 300 million people globally affected by rare diseases. Dr. Joe Wiley, CEO, highlighted the challenges faced by patients, especially those with ultra-rare diseases. The company's portfolio includes three orphan disease products: Myalept, Mycapssa, and Juxtapid. Additionally, Amryt's development candidate Oleogel-S10, under review for Epidermolysis Bullosa, offers hope for patients lacking approved treatments.
Amryt (Nasdaq: AMYT), a biopharmaceutical company focused on rare diseases, will announce its Q4 2021 and FY 2021 financial results on March 9, 2022, at 0700 EST / 1200 GMT. A conference call and webcast for analysts and investors will follow at 0830 EST / 1330 GMT. Interested parties can access the call via this link or dial in using the provided numbers for the US, UK, and Ireland. A playback facility will be available from March 9 until March 16, using the confirmation code 3077366.
Amryt has successfully secured $125 million in senior credit facilities from the Credit Group of Ares Management to strengthen its financial position. This refinancing will significantly reduce Amryt's interest expense and extend the maturity of its debt until 2027. The new facilities include an $85 million term loan with a reduced interest rate of SOFR+6.75% and a $40 million revolving credit facility. The refinancing is expected to provide strategic flexibility and support Amryt's global growth in rare diseases.
Amryt Pharma plc (Nasdaq: AMYT) has announced a General Meeting scheduled for March 2, 2022, at 2:00 p.m. GMT in Dublin, Ireland. Shareholders will vote on routine matters, including a resolution for the company to repurchase its own shares. This decision aims to provide flexibility in managing Amryt's capital resources. The meeting will prioritize COVID-19 safety protocols, and shareholders are encouraged to vote in advance. Additionally, a telephone facility will be provided for shareholder participation during the meeting.
Amryt Pharmaceuticals announced that the European Medicines Agency (EMA) will seek external advice regarding the assessment of Oleogel-S10, a treatment for Epidermolysis Bullosa (EB), a rare genetic skin disorder. The EMA's review process for Oleogel-S10 is ongoing, with an Ad-Hoc Expert Group expected to provide insights. The Committee for Medicinal Products for Human Use (CHMP) opinion is anticipated in March 2022. If approved, Oleogel-S10 could be the first therapy for EB, contributing to a global market estimated at over $1 billion.
Amryt (Nasdaq: AMYT) announced a significant patent update for its lead candidate, Oleogel-S10, on January 18, 2022. The USPTO has issued a notice of allowance for a patent application related to Oleogel-S10's formulation, which could secure its listing in the FDA's Orange Book if approved. This patent extends protection until January 2039. With this new allowance, Amryt will hold five Orange Book-listed patents for Oleogel-S10, further strengthening its intellectual property portfolio.
