Welcome to our dedicated page for Amylyx Pharmaceuticals news (Ticker: AMLX), a resource for investors and traders seeking the latest updates and insights on Amylyx Pharmaceuticals stock.
Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX) is a biopharmaceutical company focused on investigational therapies for neurodegenerative and endocrine diseases, and its news flow reflects the progress and setbacks typical of clinical-stage drug development. Company updates frequently highlight milestones in its pipeline, including avexitide for post-bariatric hypoglycemia (PBH), AMX0035 for Wolfram syndrome, AMX0114 for amyotrophic lateral sclerosis (ALS), and AMX0318 as a long-acting GLP-1 receptor antagonist candidate.
Investors following AMLX news can expect regular announcements on clinical trial progress, such as enrollment status, early safety and tolerability data, and biomarker analyses from studies like the Phase 3 LUCIDITY trial in PBH and the Phase 1 LUMINA trial in ALS. Amylyx also issues press releases when it reports financial results, providing context on research and development spending, cash runway, and the anticipated timing of key clinical and regulatory milestones.
Another recurring news theme is regulatory and program updates, including FDA designations, decisions to advance or discontinue specific programs, and detailed descriptions of conditions such as PBH, ALS, PSP, and Wolfram syndrome. The company has, for example, communicated its decision to discontinue the ORION program of AMX0035 in progressive supranuclear palsy after Phase 2b results, while continuing development of AMX0035 in Wolfram syndrome.
Amylyx also announces capital markets events and investor outreach, such as underwritten public offerings of common stock and participation in healthcare and biopharma conferences. For readers tracking AMLX, this news page offers a consolidated view of clinical, financial, and strategic disclosures that shape the company’s development trajectory. Bookmarking this feed can help investors and observers monitor how Amylyx’ investigational therapies advance through trials and how management communicates key developments.
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.
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.