Amylyx Pharmaceuticals Stock Price, News & Analysis

Amylyx Pharmaceuticals has announced a poster presentation on its Phase 3 PHOENIX trial for AMX0035, a treatment for amyotrophic lateral sclerosis (ALS). Scheduled for July 9, 2022, at the International Congress on Neuromuscular Diseases in Brussels, the poster will detail the trial's design and methodology and discuss plans for an open-label extension phase. The ongoing trial aims to enroll a broader ALS population compared to the previous CENTAUR trial, providing additional data on AMX0035's effects.

Amylyx Pharmaceuticals has announced that the FDA is planning to reconvene the Peripheral and Central Nervous System Drugs Advisory Committee to discuss the NDA for AMX0035, a treatment for ALS, on September 7, 2022. This follows the FDA's extension of the PDUFA target action date to September 29, 2022. The meeting will focus on additional analyses from clinical studies, which aim to support the reported benefits of AMX0035. The drug is currently approved for ALS in Canada under the brand name ALBRIOZA.

Amylyx Pharmaceuticals has received its first global regulatory approval from Health Canada for ALBRIOZA™ (AMX0035), a new therapy for amyotrophic lateral sclerosis (ALS) that may reduce neuronal cell death. The approval is based on positive results from the CENTAUR clinical trial, showing significant functional benefits compared to placebo. ALBRIOZA is expected to be commercially available in Canada within six weeks, pending negotiations with local authorities. Further results from the ongoing Phase 3 PHOENIX trial are anticipated in 2024.

Amylyx Pharmaceuticals (NASDAQ: AMLX) announced that the FDA has extended the PDUFA goal date for its New Drug Application (NDA) for AMX0035, a treatment for amyotrophic lateral sclerosis (ALS), to September 29, 2022. This extension allows additional time for the FDA to review new data analyses from the company's clinical studies, which was classified as a major amendment to the NDA. The CENTAUR trial, involving 137 participants, demonstrated efficacy in reducing functional decline in ALS patients.

Amylyx Pharmaceuticals announced a new post hoc analysis demonstrating significant individual responses to its drug AMX0035 in ALS patients. The findings will be presented at the ENCALS 2022 Meeting on June 2 in Edinburgh, Scotland. The study revealed a higher proportion of patients in the AMX0035 group exhibiting substantial responses compared to placebo. AMX0035 combines sodium phenylbutyrate and taurursodiol to combat neuronal death in ALS. The CENTAUR trial backing this data confirmed its efficacy and safety.

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.