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 (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.
Amylyx Pharmaceuticals (NASDAQ: AMLX) nominated AMX0318, a long-acting GLP-1 receptor antagonist, as a development candidate for post-bariatric hypoglycemia and other rare diseases after preclinical selection in collaboration with Gubra A/S. AMX0318 showed chemical stability, high solubility, strong in vitro potency, in vivo efficacy and tolerability, and a pharmacokinetic profile consistent with long-acting dosing. Amylyx plans IND-enabling studies in 2026 with an IND targeted for 2027, pending successful completion. Under the collaboration, Gubra will receive a $4 million handover milestone now and is eligible for over $50 million in success-based milestones plus mid-single-digit royalties on worldwide net sales.
Amylyx Pharmaceuticals (NASDAQ: AMLX) presented early Phase 1 LUMINA safety and tolerability data for AMX0114 at the 36th International Symposium on ALS/MND on December 5-7, 2025. In cohort 1 (n=12), AMX0114 was generally well-tolerated with no treatment-related serious adverse events, and no dose-limiting toxicities were observed to date.
Based on these data, Amylyx plans to open enrollment for cohort 2 in Canada later in December 2025 and in the U.S. in January 2026. Biomarker data from cohort 1 are expected in the first half of 2026. Presentations include safety/tolerability and preclinical biomarker characterization sessions at the MNDA symposium.
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.