Avexitide is an Amylyx Pharmaceuticals, Inc. program in post-bariatric hypoglycaemia (PBH) after Roux-en-Y gastric bypass surgery. Every date links its source.
All upcoming FDA decision dates on the 2026 PDUFA calendar
Indication under review: Post-bariatric hypoglycaemia (PBH) after Roux-en-Y gastric bypass surgery. Sponsor: Amylyx Pharmaceuticals, Inc. (AMLX). Review status: Phase 3 LUCIDITY (n=78) met the FDA-agreed primary endpoint: a 55% reduction in the composite rate of Level 2 and Level 3 hypoglycaemic events versus placebo (p=0.000003), with all secondary endpoints met and no treatment-related serious adverse events. Avexitide holds Breakthrough Therapy and Orphan Drug designations. Amylyx has said it plans to submit an NDA to the FDA by the end of 2026; no action date exists yet, because no application has been filed. We track 1 catalyst event for this program: 0 upcoming and 1 in the record. A PDUFA date is the FDA's target date to complete review of a marketing application; a readout is the sponsor's expected date for clinical trial results. What a PDUFA date is · why we do not compare trial results across drugs.
| Fund | Shares | Value at quarter end | Filing |
|---|---|---|---|
| Perceptive Advisors | 8,334,882 | $149.7 million | filed August 14, 2026 |
| Cormorant Asset Management | 200,000 | $3.6 million | filed August 14, 2026 |
| OrbiMed Advisors | 183,400 | $3.3 million | filed August 14, 2026 |
13F reports list long positions in common stock at quarter end, are due 45 days later, and show no short positions or later trades. Notes, warrants and other instruments are not counted as shares.
Avexitide's most recent tracked catalyst has already reported: positive data on Aug 18, 2026, per the company's own release (linked in the history below). No further catalyst is on our calendar yet.
No FDA decision for Avexitide is in our archive yet.
In our records Avexitide is under review or in development for Post-bariatric hypoglycaemia (PBH) after Roux-en-Y gastric bypass surgery.
Amylyx Pharmaceuticals, Inc. (AMLX).
FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.