Amylyx Pharmaceuticals Stock Price, News & Analysis

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.

Amylyx Pharmaceuticals (NASDAQ: AMLX) announced a two-year research agreement with Sunnybrook Research Institute to discover Bax and Bak inhibitor candidates for treating ALS and other neurodegenerative diseases. The collaboration aims to expedite the identification of therapeutic candidates through biochemical and in vivo studies. Promising preclinical results suggest that targeted inhibition of these proteins may preserve motor neurons and improve survival rates in ALS models. Amylyx will have rights to license successful drug candidates post-research.

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.