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Amryt (Nasdaq: AMYT) has successfully passed all shareholder resolutions at its General Meetings held on July 28, 2021, enabling the company to proceed with its acquisition of Chiasma, Inc. Shareholders approved the resolutions that grant Amryt Directors the authority to issue New Ordinary Shares for the transaction. A Chiasma Special Meeting is scheduled for August 3, 2021, to consider the merger. The completion of the transaction is anticipated soon after approval. Amryt focuses on treatments for rare diseases and has a promising pipeline of products.
Amryt Pharmaceuticals (Nasdaq: AMYT) will release its Q2 2021 financial results on August 6, 2021, at 0700 EDT. Following the report, a conference call and webcast for analysts and investors will occur at 0830 EDT. Interested participants can access the webcast through the provided URL. The company specializes in developing treatments for rare diseases and currently markets metreleptin and lomitapide. Notably, the FDA has accepted Amryt's NDA for its lead candidate, Oleogel-S10, with priority review status.
Amryt (Nasdaq: AMYT) announced a Circular regarding the acquisition of Chiasma, Inc. with a General Meeting scheduled for July 28, 2021. The acquisition is valued at approximately $339.2 million and aims to integrate Chiasma’s MYCAPSSA® product while delivering annual cost synergies of about $50 million. Amryt shareholders will own approximately 60% of the combined entity post-transaction. The deal, supported by leading security holders, is expected to complete in Q3 2021, contingent on approvals from both companies' shareholders.
Amryt Pharma has filed a preliminary registration statement for its proposed acquisition of Chiasma, Inc. in an all-stock transaction. The deal has been valued at approximately $339.2 million, based on a share exchange ratio of 0.396 Amryt ADSs for each share of Chiasma. The transaction is expected to close in the third quarter of 2021, subject to approvals from shareholders and regulatory bodies. Amryt estimates annual cost synergies of $50 million and aims to enhance its revenue from the launch of MYCAPSSA® in international markets.
Amryt's Oleogel-S10 NDA Confirmation
Amryt (Nasdaq: AMYT, AIM: AMYT) announced the FDA's confirmation that its New Drug Application (NDA) for Oleogel-S10, aimed at treating Epidermolysis Bullosa (EB), will not require an Advisory Committee meeting. This decision underscores the potential of Oleogel-S10, a treatment for a rare genetic skin disorder that currently lacks approved therapies. The product, branded as Filsuvez®, is positioned to enhance Amryt's portfolio, which includes two commercial orphan disease medications. This announcement is a significant milestone for the company.
FDA Grants Priority Review for Oleogel-S10
The FDA has granted Priority Review for Amryt's NDA for Oleogel-S10, aimed at treating Epidermolysis Bullosa (EB), a rare skin disorder. This designation accelerates review from ten to six months. The PDUFA date is set for November 30, 2021. Oleogel-S10 has previously received Fast Track and Rare Pediatric Disease Designations. If approved, it will offer a significant treatment option for EB, with the company already advancing launch plans.
Amryt Announces FDA Acceptance of New Drug Application for Oleogel-S10
Amryt (Nasdaq: AMYT) has announced that the FDA accepted its New Drug Application (NDA) for Oleogel-S10, designed to treat Epidermolysis Bullosa (EB), a severe genetic skin disorder. The acceptance was confirmed on June 2, 2021, with the FDA expected to provide further feedback by June 12, 2021. The NDA is backed by positive data from the EASE Phase 3 trial, the largest study of its kind in EB, indicating potential therapeutic benefits for patients suffering from this condition.
Amryt reported a strong Q1 2021, with revenues reaching $48.4M, up 8.7% YoY. Underlying revenue growth was 16.5% when excluding a LATAM order from Q1 2020. EBITDA increased by 115% compared to Q1 2020, reaching $9.9M. The company achieved national reimbursement for metreleptin in England, Wales, and France, alongside regulatory submissions for Oleogel-S101 to the FDA and EMA. Amryt has raised its FY 2021 revenue guidance to $205M-$210M and announced the proposed acquisition of Chiasma, Inc., aiming for a combined potential peak revenue of $1BN.
Amryt has signed an agreement to acquire Chiasma in an all-stock deal. The combined entity will feature three commercial products, including MYCAPSSA®, which has potential in the $1.9 billion neuroendocrine tumor market. The deal anticipates annual synergies of $50 million and aims for revenue and EBITDA accretion in the first year. Notably, Amryt expects to reach a peak revenue of $1 billion. The transaction involves a share exchange ratio where Chiasma shareholders will receive 0.396 Amryt ADSs per share, with the merger expected to close in Q3 2021.
Amryt (Nasdaq: AMYT, AIM: AMYT) will release its unaudited financial results for the first quarter of 2021 on May 5, 2021, at 0700 EDT/1200 BST. A conference call and webcast for analysts and investors will follow at 0830 EDT/1330 BST. Interested parties can access the webcast through a provided link. For those unable to attend, a playback facility will be available from May 5 to May 12 with specific access details. Amryt focuses on developing treatments for rare diseases, including products like Myalept and Juxtapid.
