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 will announce its third quarter 2022 financial results on November 10, 2022, after U.S. market close. The management team will hold a conference call at 4:30 p.m. ET to discuss the results and company updates. Investors can access the call by dialing either (877) 870-4263 for local or (412) 317-0790 for international attendees. A live audio webcast will also be available on the company's investor website, with an archive accessible for 90 days.
Amylyx Pharmaceuticals announced the successful completion of its upsized public offering, raising $246.3 million through the sale of 7,697,812 shares at $32.00 each. The offering included the full exercise of an option for an additional 1,004,062 shares. The funds generated will support the company's efforts in developing innovative treatments for the neurodegenerative community. The offering was managed by a consortium of financial firms, including Goldman Sachs and BofA Securities.
Amylyx Pharmaceuticals has announced an upsized public offering of 6,693,750 shares of common stock, priced at $32.00 per share, expected to generate gross proceeds of $214.2 million. The offering is set to close around October 11, 2022, pending customary conditions. The company has granted underwriters a 30-day option for an additional 1,004,062 shares. Goldman Sachs, BofA Securities, SVB Securities, and Evercore ISI are the joint book-running managers of the offering. Registration statements became effective on October 6, 2022.
Amylyx Pharmaceuticals has announced a public offering of 6,000,000 shares of common stock under an S-1 registration statement filed with the SEC. The company plans to offer all shares and may grant underwriters a 30-day option to purchase an additional 900,000 shares. The offering is subject to market conditions and may not be completed as anticipated. Goldman Sachs, BofA Securities, SVB Securities, and Evercore ISI are acting as joint book-running managers.
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™.
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