Amylyx Pharmaceuticals, Inc.AMLX
Metabolic40 cited findings · profile updated 2026-08-25
37.62 USDnot live — refreshed daily
About Amylyx Pharmaceuticals, Inc.
Amylyx Pharmaceuticals, Inc. (AMLX) is focused on metabolic research. The company is developing avexitide, which has been studied in the Phase 3 LUCIDITY trial for adults with PBH following Roux-en-Y gastric bypass (RYGB) surgery. This trial was a multicenter, randomized, double-blind, placebo-controlled study involving 78 participants across 21 sites in the United States.
The LUCIDITY trial evaluated avexitide (90 mg once daily, subcutaneously) over a 16-week double-blind treatment period. The primary outcome measured was the reduction in the composite of Level 2 and Level 3 hypoglycemic events. Avexitide demonstrated a highly statistically significant reduction in hypoglycemic events, specifically a 55% reduction in the composite rate of Level 2 and Level 3 hypoglycemic events in the LUCIDITY trial. The drug has received Breakthrough Therapy Designation, Orphan Drug Designation, and Rare Pediatric Disease Designation. An NDA submission for avexitide is targeted by the end of 2026, with commercial launch anticipated in 2027. The company also targets an IND filing for AMX0318 in 2027.
Compiled from the cited findings below — figures are as stated in each company's published technical reports and filings.
Key figures — cited
| Reduction in hypoglycemic events | highly statistically significant | Amylyx Pharmaceuticals, Inc. — SEC 8-K (2026-08-06), p.4 |
| Reduction in composite rate of Level 2 and Level 3 hypoglycemic events | 55 % | Amylyx Pharmaceuticals, Inc. — SEC 8-K (2026-08-18), p.1 |
| Designation | Breakthrough Therapy Designation | Amylyx Pharmaceuticals, Inc. — SEC 8-K (2026-08-06), p.1 |
| Designation | Orphan Drug Designation | Amylyx Pharmaceuticals, Inc. — SEC 8-K (2026-08-06), p.4 |
| Designation | Rare Pediatric Disease Designation | Amylyx Pharmaceuticals, Inc. — SEC 8-K (2026-08-06), p.4 |
| NDA submission timeline | by the end of 2026 | Amylyx Pharmaceuticals, Inc. — SEC 8-K (2026-08-18), p.2 |
Key projects
- avexitide (adults with PBH following Roux-en-Y gastric bypass (RYGB) surgery) — US
The LUCIDITY trial demonstrated a 55% reduction in the composite rate of Level 2 and Level 3 hypoglycemic events.
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