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 (AMLX) is a clinical-stage biopharmaceutical company pioneering research in neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS). This page serves as the definitive source for official updates and analysis on the company's therapeutic developments, regulatory milestones, and strategic initiatives.
Investors and researchers will find timely, verified information about clinical trial results, regulatory submissions, and research partnerships. Our curated news collection provides context for understanding Amylyx's progress in developing novel therapies while maintaining compliance with financial disclosure standards.
Key content categories include updates on ALS treatment research, FDA communications, scientific publications, and intellectual property developments. All materials are sourced directly from company filings and verified industry channels to ensure accuracy.
Bookmark this page for streamlined access to essential updates about Amylyx's innovative pipeline and its evolving role in neurodegenerative disease research. Check regularly for new developments in this dynamic clinical-stage biopharma segment.
Amylyx Pharmaceuticals (NASDAQ:AMLX) has announced the pricing of an underwritten public offering of 17.5 million shares of common stock at $10.00 per share, aiming to raise $175 million in gross proceeds.
The company has granted underwriters a 30-day option to purchase up to an additional 2.625 million shares. The proceeds will fund Avexitide commercial readiness, research and development, and general corporate purposes. The offering is expected to close around September 11, 2025.
Leerink Partners and Guggenheim Securities are serving as lead bookrunning managers, with H.C. Wainwright & Co. acting as lead manager for the offering.
Amylyx Pharmaceuticals (NASDAQ: AMLX) has announced a proposed public offering of common stock. The company will offer an undisclosed number of shares, with an additional 30-day option for underwriters to purchase up to 15% more shares. Leerink Partners and Guggenheim Securities are serving as lead bookrunning managers.
The proceeds will be used for three main purposes: Avexitide commercial readiness, research and development activities, and general working capital. The offering will be made through a shelf registration statement previously filed with the SEC.
Amylyx Pharmaceuticals (NASDAQ: AMLX) announced the discontinuation of its ORION program testing AMX0035 for Progressive Supranuclear Palsy (PSP) after the drug failed to show differences compared to placebo in primary or secondary outcomes at Week 24. The company will halt both the Phase 2b trial and its open-label extension, canceling plans for Phase 3.
While AMX0035 maintained a favorable safety profile, the company is shifting focus to other pipeline programs including: the Phase 3 LUCIDITY trial of avexitide (completion expected in 2025), AMX0035 development in Wolfram syndrome, and AMX0114 for ALS. The company maintains its cash runway projection through the end of 2026.
Amylyx Pharmaceuticals (NASDAQ:AMLX) has announced its participation in five major investor conferences in September 2025. The company's management will engage in fireside chats and presentations at events hosted by Citi, Cantor, Morgan Stanley, Baird, and H.C. Wainwright in Boston and New York City.
All conference presentations will be accessible via live webcast through the company's investor relations website, with recordings available for 90 days after each event.
Amylyx Pharmaceuticals (NASDAQ: AMLX) reported Q2 2025 financial results and clinical pipeline updates. The company maintains a strong cash position of $180.8 million as of June 30, 2025, with runway through 2026. Key highlights include expected completion of recruitment for the Phase 3 LUCIDITY trial of avexitide in PBH in 2025, with topline data anticipated in H1 2026.
The company reported positive data from multiple clinical programs: Phase 2b trial of avexitide showed 64% reduction in hypoglycemic events, Week 48 data from HELIOS trial of AMX0035 in Wolfram syndrome demonstrated sustained improvements, and AMX0114 received FDA Fast Track designation for ALS treatment. Q2 2025 financial results showed a net loss of $41.4 million ($0.46 per share), improved from $72.7 million loss in Q2 2024.
Amylyx Pharmaceuticals (NASDAQ:AMLX) has scheduled its second quarter 2025 financial results announcement for Thursday, August 7, 2025. The company's senior management will host a conference call and audio webcast at 8:00 a.m. ET to discuss financial results and company updates.
Investors can access the conference call via U.S. & Canada toll-free number (+1 800-836-8184) or international number (+1 646-357-8785). A live audio webcast will be available on the company's investor website, with a replay accessible for 90 days following the event.
Amylyx Pharmaceuticals (NASDAQ: AMLX) presented new exploratory analyses from Phase 2 and Phase 2b trials of avexitide, a first-in-class GLP-1 receptor antagonist, at ENDO 2025. The drug, which has FDA Breakthrough Therapy designation, showed promising results for post-bariatric hypoglycemia (PBH) treatment.
Key findings include a 64% reduction in Level 2 and Level 3 hypoglycemic events with avexitide 90 mg once daily, with over half of participants experiencing no events during treatment. Pharmacokinetic data confirmed sustained therapeutic exposure for 24 hours. The pivotal Phase 3 LUCIDITY trial is currently ongoing, with recruitment completion expected in 2025 and topline data in first half of 2026.
Amylyx Pharmaceuticals (NASDAQ: AMLX) announced an upcoming investor event at ENDO 2025 on July 13, 2025, focusing on post-bariatric hypoglycemia (PBH) and their drug candidate avexitide. The event will feature presentations of new analyses from Phase 2 PREVENT and Phase 2b clinical trials, including data on hypoglycemic events and pharmacological activity of the 90 mg daily dose.
The company will present two posters at ENDO 2025: one on population pharmacokinetics analysis and another on hypoglycemic event reduction. Notable experts from Stanford University and University of Colorado will join Amylyx's management team. The company's Phase 3 LUCIDITY trial is ongoing, with recruitment completion expected in 2025, data readout in H1 2026, and potential commercial launch in 2027.
Amylyx Pharmaceuticals (NASDAQ: AMLX) has announced its participation in three major investor conferences in June 2025:
- Jefferies Global Healthcare Conference: Fireside chat on June 5, 2025, at 1:25 p.m. ET in New York City
- Goldman Sachs 46th Annual Global Healthcare Conference: Fireside chat on June 10, 2025, at 3:20 p.m. ET in Miami, Florida
- Virtual H.C. Wainwright @ Home Fireside Chat Series: Fireside chat on June 26, 2025, at 11:00 a.m. ET
Live webcasts of all presentations will be available on the company's investor relations website for 90 days after the events.
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