Amylyx Pharmaceuticals Stock Price, News & Analysis

Amylyx Pharmaceuticals (NASDAQ: AMLX) announced the outcome of the FDA's PCNSDAC meeting regarding its NDA for AMX0035, intended for ALS treatment. The advisory committee voted 4 (yes) to 6 (no) on whether the data supports AMX0035's effectiveness. Nonetheless, Amylyx remains confident in the drug's potential and continues to seek FDA approval, which is expected by June 29, 2022. AMX0035 is designed to target pathways involved in neuronal degeneration. The CENTAUR trial met its primary efficacy endpoint, demonstrating a reduction in functional decline.

Amylyx Pharmaceuticals (AMLX) announced that Nasdaq has halted trading of its common stock.

The FDA's Peripheral and Central Nervous System Drugs Advisory Committee is meeting to review the New Drug Application (NDA) for AMX0035, a treatment for ALS, scheduled for discussion at 10:00 a.m. ET. The target action date set by the Prescription Drug User Fee Act for the NDA is June 29, 2022.

The company continues to develop novel therapies for neurodegenerative diseases.

Amylyx Pharmaceuticals announced the FDA briefing documents for the PMDA meeting regarding their New Drug Application (NDA) for AMX0035, aimed at treating amyotrophic lateral sclerosis (ALS). The meeting is scheduled for March 30, 2022, at 10 a.m. ET, with the PDUFA target action date set for June 29, 2022. AMX0035 combines sodium phenylbutyrate (PB) and taurursodiol (TURSO) to reduce neuronal death in ALS. The success of this application could significantly impact Amylyx's future as a clinical-stage biopharmaceutical company.

Amylyx Pharmaceuticals has launched an Expanded Access Program (EAP) for its drug AMX0035, targeting individuals with amyotrophic lateral sclerosis (ALS) in the U.S. The program, designed in collaboration with the ALS community, aims to provide access to potential therapies prior to FDA approval. Eligible participants cannot overlap with those in the ongoing Phase 3 PHOENIX trial. AMX0035 is a combination of sodium phenylbutyrate and taurursodiol, targeting neuronal degeneration in ALS and other neurodegenerative diseases.

Amylyx Pharmaceuticals (AMLX) has announced that its Marketing Authorisation Application for AMX0035, a treatment for amyotrophic lateral sclerosis (ALS), has been validated by the European Medicines Agency (EMA) and is now under review. The application is supported by positive data from the CENTAUR trial, which indicated that AMX0035 reduced clinical decline and improved survival rates compared to placebo. The company is preparing its European team for a potential launch pending a favorable review outcome.

Amylyx Pharmaceuticals has appointed Gina M. Mazzariello as its new Chief Legal Officer and General Counsel. Ms. Mazzariello brings over 20 years of experience in healthcare law, including extensive knowledge in drug commercialization and regulatory matters. Prior to joining Amylyx, she served at Boehringer Ingelheim USA, where she led legal operations for the human pharmaceuticals division. Her expertise is expected to facilitate Amylyx's global expansion and regulatory approvals, reinforcing their commitment to the neurodegenerative community.

Amylyx Pharmaceuticals announced a virtual FDA advisory committee meeting on March 30, 2022, to review the New Drug Application (NDA) for AMX0035, an investigational therapy for amyotrophic lateral sclerosis (ALS). The FDA has prioritized this review with a Prescription Drug User Fee Act date set for June 29, 2022. AMX0035 is a combination of sodium phenylbutyrate and taurursodiol, aimed at reducing neuronal death in ALS. The company anticipates a thorough scientific discussion on the clinical data backing their application.

Amylyx Pharmaceuticals will present at the 11th Annual SVB Leerink Global Healthcare Conference on February 17, 2022, at 4:20 PM ET. Co-CEOs Joshua Cohen and Justin Klee will host the virtual presentation. Interested parties can access a live webcast through the Company’s investor section on their website, with a replay available for 90 days post-event.

Amylyx is focused on developing therapies for amyotrophic lateral sclerosis (ALS) and other neurodegenerative diseases.

Amylyx Pharmaceuticals (NASDAQ: AMLX) has partnered with the Canadian Neuromuscular Disease Registry (CNDR) for a real-world evidence initiative concerning its investigational therapy, AMX0035, aimed at treating amyotrophic lateral sclerosis (ALS). This collaboration will collect demographic, clinical, functional, and survival data on ALS patients using AMX0035 across Canada. The partnership is expected to generate valuable insights into AMX0035's impact on ALS treatment, enhancing patient access to therapies and potentially shaping future treatment protocols.