Amylyx Pharmaceuticals Stock Price, News & Analysis

Amylyx Pharmaceuticals (NASDAQ: AMLX) announced new findings from the Phase 2 CENTAUR trial, highlighting significant benefits of AMX0035 in patients with amyotrophic lateral sclerosis (ALS). The treatment reduces the risk of death or tracheostomy/permanent assisted ventilation by 49% and lowers the rate of first hospitalization by 44%. Additionally, participants showed a median key event-free survival duration of 4.8 months longer with AMX0035. These results underscore AMX0035's potential impact on delaying severe medical interventions for ALS patients.

Amylyx Pharmaceuticals (AMLX) is progressing towards the commercial launch of AMX0035 for ALS treatment in the U.S. and Canada, contingent on regulatory approval. Recent Phase 2 trial data published in Muscle & Nerve highlight significant survival benefits of AMX0035. The FDA's PDUFA date is June 29, 2022. Financially, R&D expenses surged to $21.5 million and G&A expenses to $26.4 million in Q1 2022, resulting in a net loss of $47.8 million. However, cash reserves improved to $255.2 million following an IPO in January 2022.

Amylyx Pharmaceuticals has published new long-term survival analyses from the Phase 2 CENTAUR trial for AMX0035 (sodium phenylbutyrate and taurursodiol) in ALS patients. The analysis using the rank-preserving structural failure time model estimated a median survival increase of 10.6 months for AMX0035 participants compared to placebo. In specific subgroups, those who transitioned to the open-label extension phase exhibited an even greater median survival increase of 18.8 months. The results highlight the potential survival benefits of AMX0035 in addressing ALS and are detailed in the peer-reviewed journal Muscle & Nerve.

Amylyx Pharmaceuticals announced data from the CENTAUR and PEGASUS clinical trials, confirming that AMX0035 is safe and well tolerated in patients with amyotrophic lateral sclerosis (ALS) and Alzheimer’s disease (AD). The majority of treatment-emergent adverse events (TEAEs) were gastrointestinal, with no new safety signals identified. These findings clarify the safety profile of AMX0035. Participants from both trials reported similar incidences of TEAEs, attributed largely to disease progression in ALS. The data will be presented at the AAN conference on April 4, 2022.

Amylyx Pharmaceuticals, Inc. (AMLX) reported a transformative year in 2021, focusing on the progress of AMX0035 for ALS treatment. The FDA set a PDUFA action date of June 29, 2022. The company successfully submitted regulatory applications in the U.S., Europe, and Canada. Financially, R&D expenses rose to $44 million, while general and administrative expenses reached $38.9 million, resulting in a net loss of $87.9 million for 2021. Despite this, cash reserves significantly improved to $96.1 million, bolstered by a successful IPO that raised $196.9 million in net proceeds.

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.