Amylyx reports positive LUCIDITY Phase 3 data for avexitide, raises $545 million

Amylyx Pharmaceuticals reported on November 5, 2026 that its Phase 3 LUCIDITY trial of avexitide in post-bariatric hypoglycemia (PBH) following Roux-en-Y gastric bypass surgery met its prespecified primary endpoint, showing a 55% reduction in the composite rate of Level 2 and Level 3 hypoglycemic events compared with placebo (p=0.000003), and met all secondary endpoints with what the company described as consistent, highly statistically significant results.¹ The company said avexitide was generally well tolerated through the double-blind period, with a safety profile it called favorable.¹ The trial's 32-week open-label extension and an avexitide Expanded Access Program for eligible PBH patients remain ongoing.¹

Amylyx plans to present full LUCIDITY data in a late-breaking session at ObesityWeek on November 15, 2026, and remains on track to submit a New Drug Application to the FDA by the end of 2026, building on the Breakthrough Therapy Designation the agency previously granted avexitide for PBH.¹

In its ALS program, Amylyx said it finished enrolling a 12-person third cohort and opened a fourth cohort in the Phase 1 LUMINA trial of AMX0114, an antisense oligonucleotide targeting calpain-2 that holds FDA Fast Track designation.¹

On the balance sheet, the company closed an underwritten public offering with net proceeds of about $544.6 million.¹ Cash, cash equivalents and marketable securities stood at $768.1 million as of September 30, 2026, up from $250.8 million at June 30, 2026.¹ Net loss for the third quarter was $45.5 million, or $0.38 per share, compared with a net loss of $34.4 million, or $0.37 per share, in the same period of 2025.¹