Amylyx Pharmaceuticals to Report Third Quarter 2026 Financial Results on November 5, 2026

Amylyx Pharmaceuticals reported Q3 operating expenses rose 38% to $49.7M, with R&D up 43% to $28.4M. The company plans to submit an FDA application for avexitide by year-end, targeting 160,000 U.S. patients with PBH. Amylyx is also advancing its pipeline, including AMX0318 and AMX0114, with a 2027 IND filing targeted for the former.

Amylyx Pharmaceuticals reported no product revenue in Q3 2026, with a net loss of $45.49M, up 32.3% YoY. Higher R&D costs were partially offset by increased interest income. Avexitide's Phase 3 trial met its primary endpoint, and the company plans an NDA submission by year-end 2026. AMX0114 and AMX0318 are in early stages of development.

Amylyx Pharmaceuticals, Inc. (AMLX) filed an SEC Form 8-K — Results of Operations and Financial Condition. Exhibit 99.1 Amylyx Pharmaceuticals Reports Third Quarter 2026 Financial Results • Reported positive topline results from Phase 3 LUCIDITY clinical trial of avexitide in post-bariatric hypoglycemia; New Drug Application submission planned by end of 2026 remains on track • Results

Amylyx Pharmaceuticals reported positive Phase III results for avexitide in treating PBH, with plans to file for FDA approval by year-end. The company estimates 160,000 U.S. patients with PBH, with 120,000 following Roux-en-Y gastric bypass. Management is preparing for a potential 2024 or 2027 launch, depending on the FDA label. Amylyx is also developing AMX0318 for PBH, targeting an IND filing next year.

Amylyx Pharmaceuticals (AMLX) shares fell as investors took profits after a rally driven by positive Phase 3 data for avexitide. Concerns include valuation, dilution from a $500M stock offering, and insider sales. The company faces high funding needs for commercialization around 2027, shifting focus to financial costs and capital access.

Amylyx Pharmaceuticals (AMLX) shares rose 14% after-hours as it prepares to release Phase 3 trial results for avexitide, its lead drug candidate for post-bariatric hypoglycemia. The trial's success could support a 2027 regulatory filing. AMLX has no FDA-approved therapies currently, and its cash runway extends into 2028. Mizuho raised its price target to $30, citing potential launch pricing updates.