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.
Tortugas Neuroscience has appointed Jim Frates to its Board of Directors and named him Chair of the Audit Committee. Frates is a veteran biopharmaceutical finance executive who currently serves as chief financial officer of Amylyx Pharmaceuticals (AMLX) and previously spent more than two decades as CFO of Alkermes (ALKS).
Tortugas, launched in April 2026, is a clinical-stage CNS-focused biotech developing small molecule new chemical entities with differentiated mechanisms of action. Its in-licensed pipeline from Jiangsu Hansoh Pharmaceutical Group and Eisai includes potential treatments for schizophrenia, tinnitus, focal epilepsy, reversible encephalopathies and other high unmet-need CNS indications.
During Frates’ tenure at Alkermes, the company grew from a clinical-stage enterprise to an international commercial organization with multiple products, more than $1 billion in revenue and over 2,000 employees, and completed numerous acquisitions and financings. Frates expressed enthusiasm for supporting Tortugas’ leadership in advancing its clinical programs.
Amylyx Pharmaceuticals (AMLX)/b) will participate in the 24th Annual Morgan Stanley Global Healthcare Conference.The company’s management will host a fireside chat on September 15, 2026, at 12:20 p.m. ET. A live webcast and 90-day replay will be available under “Events and Presentations” in the Investor section of Amylyx’s website.
Amylyx Pharmaceuticals (Nasdaq: AMLX) priced an upsized underwritten public offering of 14,090,000 common shares at $35.50 per share, for expected gross proceeds of approximately $500.2 million before fees and expenses. All shares are being sold by Amylyx, with underwriters granted a 30‑day option to purchase up to 2,113,500 additional shares at the same public price, less underwriting discounts and commissions.
According to Amylyx, net proceeds, together with existing cash and investments, will fund pre‑commercial activities for avexitide (including added manufacturing capacity), research and development, and working capital and general corporate purposes. The offering is expected to close on or about August 21, 2026, subject to customary closing conditions, with Leerink Partners, Morgan Stanley, Guggenheim Securities and LifeSci Capital as joint bookrunning managers.
Amylyx Pharmaceuticals (Nasdaq: AMLX) commenced an underwritten public offering of $350.0 million of its common stock. The company also plans to grant underwriters a 30‑day option to buy up to an additional $52.5 million in shares at the public offering price, less underwriting discounts and commissions.
According to Amylyx, all shares are being sold by the company, with net proceeds, together with existing cash, earmarked for pre-commercial activities for avexitide, research and development, and working capital and general corporate purposes. Leerink Partners, Morgan Stanley, Guggenheim Securities and LifeSci Capital are joint bookrunning managers.
Amylyx Pharmaceuticals (Nasdaq: AMLX) reported positive topline results from LUCIDITY, a 78‑participant, multicenter, randomized, double‑blind, placebo‑controlled Phase 3 trial of avexitide, a GLP‑1 receptor antagonist, in post‑bariatric hypoglycemia (PBH) after Roux‑en‑Y gastric bypass.
LUCIDITY met its FDA‑agreed primary endpoint, showing a 55% reduction in the composite rate of Level 2 and Level 3 hypoglycemic events versus placebo through Week 16 (p=0.000003). All secondary endpoints were met, with statistically significant and clinically meaningful reductions in SMBG‑measured Level 2 events, CGM‑measured Level 2 events, and independently adjudicated Level 3 events.
Avexitide was generally well‑tolerated; most adverse events were mild to moderate, with no serious adverse events related to treatment and no body‑weight changes in either arm. According to Amylyx, avexitide has FDA Breakthrough Therapy and Orphan Drug Designations, and the company plans to submit an NDA by the end of 2026 and is preparing for a potential 2027 commercial launch, if approved.
Amylyx Pharmaceuticals (Nasdaq: AMLX) plans to announce topline results from its Phase 3 LUCIDITY clinical trial of Avexitide in post-bariatric hypoglycemia on August 18, 2026. The company’s senior management will discuss the results on a conference call and live audio webcast at 8:00 a.m. ET.
Investors can join the call by dialing +1 (888) 880-3330 (U.S. & Canada) or +1 (646) 357-8766 (international) at least 10 minutes before start and requesting the Amylyx Pharmaceuticals call. A live webcast and 90-day replay will be available under “Events and Presentations” in the Investor section of the company’s website.
Amylyx Pharmaceuticals (Nasdaq: AMLX) reported second quarter 2026 results and R&D updates, highlighted by completion of the last participant’s final visit in the 16‑week double‑blind period of the pivotal Phase 3 LUCIDITY trial of avexitide in post-bariatric hypoglycemia (PBH). Topline data are expected in late August or early September 2026, with a potential U.S. launch in 2027 if approved.
Q2 2026 research and development expenses were $23.8 million and selling, general and administrative expenses were $21.9 million. Net loss was $43.4 million, or $0.39 per share. Cash, cash equivalents, and short-term investments totaled $250.8 million at June 30, 2026, and Amylyx expects its cash runway to extend into 2028.
The company also reported safety-supportive Phase 1 LUMINA data for AMX0114 in ALS, longer-term Phase 2 HELIOS data for AMX0035 in Wolfram syndrome, progress on AMX0318 IND-enabling studies, a new research collaboration with Gubra, and initiation of a U.S. Expanded Access Program for avexitide in PBH.
Amylyx Pharmaceuticals (Nasdaq: AMLX) plans to report its second quarter 2026 financial results on Thursday, August 6, 2026. The company’s senior management will host a conference call and live audio webcast at 8:00 a.m. ET to review the results and provide company updates.
Investors can access the call by dialing +1 (888) 880-3330 (U.S. & Canada) or +1 (646) 357-8766 (international) at least 10 minutes before the start and requesting the Amylyx Pharmaceuticals call. A live webcast and a 90-day replay will be available under “Events and Presentations” in the Investor section of https://investors.amylyx.com/events-presentations.
Amylyx Pharmaceuticals (NASDAQ: AMLX) reported initial data from its first-in-human, dose-ranging Phase 1 LUMINA trial of AMX0114 in ALS, to be presented at ENCALS 2026.
Cohort 1 (12.5 mg) showed no drug-related SAEs, stable ALS biomarkers, and supports escalation to higher doses.
Amylyx Pharmaceuticals (NASDAQ: AMLX) will present two posters at the Endocrine Society’s ENDO 2026 meeting in Chicago, June 13–16, 2026. One examines the burden of post-bariatric hypoglycemia (PBH) in the U.S.; the other covers participant-informed design of the pivotal Phase 3 LUCIDITY trial of avexitide, an investigational GLP-1 receptor antagonist for PBH.