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) reported Q3 2025 results and clinical updates on November 6, 2025. The company expects completion of recruitment for the Phase 3 LUCIDITY trial in Q1 2026 with topline data in Q3 2026, and if approved plans a potential commercial launch of avexitide in 2027. Amylyx closed an underwritten public offering with ~$191 million net proceeds, leaving cash, cash equivalents and marketable securities of $344.0 million at September 30, 2025 and an expected cash runway into 2028. Phase 2b data showed avexitide 90 mg once daily produced a 64% reduction in composite Level 2/3 hypoglycemic events (p=0.0031). Management will host a conference call on November 6, 2025 at 8:00 a.m. ET.
Amylyx Pharmaceuticals (Nasdaq: AMLX) announced management will present live, in-person fireside chats at three investor conferences in November–December 2025: the Guggenheim Healthcare Innovation Conference on Nov 10, 2025 at 4:30 PM ET in Boston, the Evercore Healthcare Conference on Dec 2, 2025 at 8:20 AM ET in Coral Gables, and Citi's Global Healthcare Conference on Dec 3, 2025 at 4:00 PM ET in Miami.
A live webcast will be available under the company’s Investor Events and Presentations page and replays will remain accessible for 90 days after each event.
Amylyx Pharmaceuticals (NASDAQ: AMLX) will report third quarter 2025 financial results on Thursday, November 6, 2025. Senior management will host a conference call and audio webcast at 8:00 a.m. ET to discuss results and company updates.
Dial-in numbers are +1 (888) 880-3330 (U.S. & Canada) or +1 (646) 357-8766 (international); callers should dial at least 10 minutes early. A live audio webcast will be available under Events and Presentations in the Investor section at https://investors.amylyx.com/events-presentations and will be archived for 90 days after the call.
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.