Amylyx Pharmaceuticals, Inc. AMLX
Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) is an endocrine/women's health drug developer. Its lead program, avexitide, is in Phase 3 for post-bariatric hypoglycemia (PBH). Its next catalyst on record is AMX0318: IND submission (2027).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: AMX0318 — IND submission (2027). 1 catalyst on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| avexitide | post-bariatric hypoglycemia (PBH) after RYGB | protein/peptide | Phase 3 |
| AMX0035 | Wolfram syndrome | small molecule | Phase 2 |
| AMX0114 | ALS | RNA (siRNA/ASO/mRNA) | Phase 1 |
| AMX0318 | PBH and other rare diseases | protein/peptide | Pre-clinical |
Recent results and decisions
- Aug 18, 2026met Phase 3 LUCIDITY met primary endpoint: 55% reduction in composite Level 2/3 hypoglycemic events vs placebo (rate ratio 0.45, p=0.000003); all secondaries met.
LUCIDITY met FDA-agreed-upon primary endpoint; avexitide demonstrated a 55% reduction in the composite rate of Level 2 and Level 3 hypoglycemic events compared to placebo (p=0.000003)
Filing - Aug 6, 2026positive HELIOS Week 96 (n=9): pancreatic function and glycemic control stable or improved in most participants; open-label single-arm.
At Week 96, measures of pancreatic function and other measures of glycemic control were stable or improved relative to baseline in most participants.
Filing - Aug 6, 2026positive LUMINA Cohort 1 (lowest dose): no drug-related SAEs and no serious neurological AEs.
AMX0114 showed no drug-related serious adverse events (AEs) and no serious neurological AEs in Cohort 1, supporting continued evaluation at higher dose levels.
Filing
1 more on record.
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 3 endocrine/women's health companies
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.