Amylyx Pharmaceuticals Stock Price, News & Analysis

Amylyx Pharmaceuticals announced that the FDA has approved RELYVRIO (sodium phenylbutyrate and taurursodiol) for treating adults with amyotrophic lateral sclerosis (ALS).

RELYVRIO significantly slowed physical function loss in clinical trials, offering hope for approximately 29,000 ALS patients in the U.S. with median survival from diagnosis of 2-3 years. The drug is expected to be accessible through specialty pharmacies within 4-6 weeks. Amylyx plans to support ALS patients with a dedicated care team.

Amylyx Pharmaceuticals announced that clinical data from the placebo group of the CENTAUR trial for AMX0035 are now accessible in the PRO-ACT database. This initiative supports the ALS research community by enabling collaborative efforts to uncover new treatment pathways. The PRO-ACT platform, awarded for its innovation, contains data from over 11,600 ALS participants and has been essential for numerous publications. AMX0035, under evaluation for ALS, aims to reduce neuronal cell death.

Amylyx Pharmaceuticals (NASDAQ: AMLX) announced significant preclinical data demonstrating that AMX0035, a combination of sodium phenylbutyrate and taurursodiol, has a pronounced effect on ALS-relevant molecular pathways compared to individual components. The published study in Annals of Clinical and Translational Neurology showed AMX0035 altered more genes and metabolites in fibroblasts from ALS patients than either compound alone. This underscores its potential benefits in treating ALS, a disease affecting over 90% of ALS patients.

Amylyx Pharmaceuticals has received a positive vote from the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee, with a 7:2 vote supporting the approval of AMX0035 for treating ALS. If approved, it will be the first treatment to show significant slowing of disease progression and functional decline in ALS. The final decision from the FDA is expected by September 29, 2022. The clinical trial data for AMX0035 indicated potential benefits in overall survival and was well tolerated, with the CENTAUR trial meeting its primary efficacy endpoint.

Amylyx Pharmaceuticals announced that Nasdaq has halted trading of its common stock in conjunction with the second FDA Advisory Committee meeting regarding the NDA for AMX0035, aimed at treating ALS. This meeting is crucial for reviewing AMX0035, previously discussed on March 30, 2022. The FDA's target action date for this application is set for September 29, 2022. The company emphasizes its commitment to the neurodegenerative community through innovative treatments.

Amylyx Pharmaceuticals announced the reconvened meeting of the Peripheral and Central Nervous System Drugs Advisory Committee (PCNSDAC) by the FDA to review the New Drug Application (NDA) for AMX0035, a treatment for amyotrophic lateral sclerosis (ALS). Scheduled for September 7, 2022, this follows a previous meeting on March 30, 2022. The NDA's target action date is September 29, 2022, which was extended for further analysis of clinical data. AMX0035 is under regulatory review in the U.S. and EU, and is already approved in Canada as ALBRIOZA™.

Amylyx Pharmaceuticals (AMLX) announced the launch of ALBRIOZA™ (AMX0035) in Canada, marking its first commercial product. The FDA has scheduled an advisory meeting on September 7, 2022, regarding the NDA for AMX0035 for ALS, with a PDUFA action date set for September 29, 2022. Financial results for Q2 2022 show a net loss of $54.1 million, up from $21.9 million year-over-year, primarily due to increased R&D and administrative costs. Cash reserves stood at $206.7 million as of June 30, 2022, indicating ongoing funding for development and launch activities.

Amylyx Pharmaceuticals (NASDAQ: AMLX) announced the U.S. FDA's Peripheral and Central Nervous System Drugs Advisory Committee will reconvene on September 7, 2022, to review the New Drug Application (NDA) for AMX0035, a treatment for amyotrophic lateral sclerosis (ALS). The review follows a previous meeting on March 30, 2022, and the FDA's extension of the PDUFA target action date from June 29 to September 29, 2022. The company emphasizes the urgent need for effective ALS treatments and is confident in the clinical data supporting AMX0035's benefits.

Amylyx Pharmaceuticals announced the commercial availability of ALBRIOZA™ (sodium phenylbutyrate and ursodoxicoltaurine) in Canada for ALS patients. This oral therapy may reduce neuronal cell death and was shown to significantly slow disease progression in clinical trials. Amylyx is actively pursuing reimbursement options with various Canadian health organizations to ensure patient access. CEO Tammy Moore emphasized the importance of equitable access to ALBRIOZA for Canadians living with ALS. The drug is also under review for marketing in the US and EU.