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. develops investigational therapies for endocrine conditions and neurodegenerative diseases with high unmet medical need. News about AMLX centers on its clinical-stage pipeline, including avexitide, a GLP-1 receptor antagonist being evaluated for post-bariatric hypoglycemia, and additional programs such as AMX0035, AMX0114 and AMX0318.
Recurring company updates cover clinical trial progress, expanded access activity, development-candidate selections, program discontinuations, quarterly financial results and investor presentations. Amylyx news also reflects regulatory and commercial-readiness topics tied to investigational therapies, collaboration updates and capital-runway commentary typical of a biotechnology issuer advancing multiple development programs.
Amylyx Pharmaceuticals (Nasdaq: AMLX) reported peer-reviewed Phase 2 HELIOS data for AMX0035 in adults with Wolfram syndrome, now published in The Journal of Clinical Investigation.
At Weeks 24 and 48, results showed improved pancreatic beta cell function, better glycemic control, vision stabilization trends, and generally mild-to-moderate adverse events. The company is working with the FDA on a Phase 3 trial.
Amylyx (Nasdaq: AMLX) reported Q1 2026 results and clinical updates on May 7, 2026. Key points: LUCIDITY enrollment complete (78 participants), topline Phase 3 avexitide data expected in Q3 2026, Expanded Access Program initiated May 2026, cash, cash equivalents and short-term investments of $279.8M, and an expected cash runway into 2028.
R&D and SG&A increased; net loss was $41.3M ($0.37 per share) for Q1 2026.
Amylyx Pharmaceuticals (Nasdaq: AMLX) said management will participate in two upcoming in-person investor conferences: Bank of America 2026 Health Care Conference on May 13, 2026 at 1:40 p.m. PT in Las Vegas, and Goldman Sachs 47th Annual Global Healthcare Conference on June 10, 2026 at 10:40 a.m. ET in Miami.
A live webcast will be available via the company’s Investor "Events and Presentations" page and replayable for 90 days after each event.
Amylyx (Nasdaq: AMLX) launched a U.S. Expanded Access Program (EAP) to provide avexitide to up to 250 adults with post-bariatric hypoglycemia (PBH) after Roux-en-Y gastric bypass. Avexitide is investigational and is being evaluated in the Phase 3 LUCIDITY trial; topline data are anticipated in Q3 2026 and potential commercial launch is anticipated in 2027.
The EAP permits physicians to request avexitide for eligible patients who cannot join trials and have exhausted management options; access is limited and not guaranteed.
Amylyx Pharmaceuticals (Nasdaq: AMLX) will report first quarter 2026 financial results on Thursday, May 7, 2026. Senior management will host a conference call and live audio webcast at 8:00 a.m. ET to discuss results and company updates. The webcast will be archived for 90 days.
Amylyx Pharmaceuticals (Nasdaq: AMLX) will present at the 25th Annual Needham Virtual Healthcare Conference on Wednesday, April 15, 2026 at 8:45 a.m. ET.
A live webcast will be available via the company’s Investor "Events and Presentations" page and replayable for 90 days, according to the company.
Amylyx (Nasdaq: AMLX) announced completion of enrollment in the pivotal Phase 3 LUCIDITY trial of avexitide for post-bariatric hypoglycemia, with the last participant randomized and dosed and a total of 78 participants enrolled.
The 16-week double-blind trial evaluates the FDA-agreed primary outcome of reduction in the composite of Level 2 and Level 3 hypoglycemic events through Week 16. Topline data are anticipated in Q3 2026, with commercial launch targeted in 2027 if approved; NDA-readiness preparations are underway.
Amylyx Pharmaceuticals (Nasdaq: AMLX) reported Q4 and full-year 2025 results and clinical updates on March 3, 2026. Key points: LUCIDITY recruitment is complete for the Phase 3 avexitide trial with topline data expected in Q3 2026, cash, cash equivalents and short-term investments of $317.0M at 12/31/2025, and a cash runway expected into 2028. Full-year net loss narrowed to $144.7M ($1.53/sh). The company advanced preclinical candidate AMX0318 and reported early Phase 1 AMX0114 tolerability data.
Amylyx Pharmaceuticals (Nasdaq: AMLX) announced management will present at two investor conferences in March 2026: TD Cowen 46th Annual Health Care Conference on March 3, 2026 at 11:10 a.m. ET in Boston, and Leerink Global Healthcare Conference on March 10, 2026 at 8:00 a.m. ET in Miami.
A live webcast of both presentations will be available via the company’s Investor "Events and Presentations" page and replayable for 90 days after each event.
Amylyx Pharmaceuticals (Nasdaq: AMLX) will report fourth quarter and full year 2025 financial results on March 3, 2026. Senior management will host a conference call and live audio webcast at 8:00 a.m. ET to discuss results and company updates.
The webcast will be archived and available for replay for 90 days under the Investor > Events and Presentations section at the company’s website.