Amylyx is nearing an FDA filing for avexitide, a GLP-1 receptor antagonist for post-bariatric hypoglycemia, a complication affecting 160,000 Americans with no approved treatments.
PBH strikes when bariatric surgery rewires the body’s GLP-1 response, triggering insulin surges that crash blood sugar. Patients can lose consciousness without warning; many can’t safely be alone. Avexitide blocks GLP-1 receptors on pancreatic islet beta cells, cutting off the excessive insulin release before it starts. Amylyx acquired the asset from Eiger BioPharmaceuticals in July 2024.
Relyvrio, cleared by FDA in September 2022 as only the third drug approved for ALS, failed the Phase 3 PHOENIX trial in March 2024: no significant difference versus placebo at 48 weeks. Amylyx’s stock crashed more than 80%. The withdrawal cost roughly 70% of the company’s workforce.
Avexitide’s pivotal-study topline data is due in Q3. If positive, Amylyx says it’ll submit the NDA “as soon as possible” and expects a commercial launch next year, per its May first-quarter earnings report.
The avexitide acquisition runs counter to the current GLP-1 trend. The dominant agonist class (Ozempic, Wegovy) makes headlines by amplifying the very receptor avexitide blocks. PBH patients are the inverse case: bariatric surgery has already made GLP-1 overactive, not underactive, and blocking it is the fix. For 160,000 patients with nothing, Amylyx’s path to approval is clear if the data holds.
Pivotal topline data lands Q3.
Sarah Chen