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 avexitide: NDA submission to FDA (Q4 2026).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: avexitide — NDA submission to FDA (Q4 2026). 3 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| avexitide | post-bariatric hypoglycemia (PBH) | protein/peptide | Phase 3 |
| AMX0035 | Wolfram syndrome | small molecule | Phase 2 |
| avexitide | congenital hyperinsulinism (congenital HI) | protein/peptide | Phase 1 |
| AMX0114 | amyotrophic lateral sclerosis (ALS) | RNA (siRNA/ASO/mRNA) | Phase 1 |
| AMX0318 | PBH and other rare diseases | protein/peptide | Pre-clinical |
Recent results and decisions
- Nov 5, 2026met Amylyx reported positive topline results from Phase 3 LUCIDITY trial of avexitide in post-bariatric hypoglycemia, meeting primary and all secondary endpoints.
LUCIDITY met the prespecified primary endpoint demonstrating a 55% reduction in the composite rate of Level 2 and Level 3 hypoglycemic events compared to placebo (p=0.000003), and met all secondary endpoints.
Filing - Nov 5, 2026positive Amylyx presented Phase 1 LUMINA trial data for AMX0114 from the initial two dose cohorts at the Annual NEALS Meeting.
Amylyx recently presented data from the Phase 1 LUMINA clinical trial of AMX0114 at the Annual NEALS Meeting from the initial two dose cohorts.
Filing - Nov 5, 2026completed enrollment Amylyx completed enrollment of Cohort 3 and began enrollment of Cohort 4 in the Phase 1 LUMINA trial of AMX0114.
Amylyx recently completed enrollment of Cohort 3 (n=12) and began enrollment of Cohort 4 of the Phase 1 LUMINA clinical trial of AMX0114.
Filing
4 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.