Amylyx Pharmaceuticals (AMLX)

Executive Summary

Amylyx Pharmaceuticals is a biopharmaceutical company focused on neurodegenerative diseases. Its lead product, AMX0035 (RELYVRIO/ALBRIOZA), was approved for ALS in 2022 but voluntarily withdrawn from the US market following the failure of the Phase 3 PHOENIX trial in 2024. Despite this setback, the company has diversified its pipeline across multiple indications. Notable assets include avexitide, a GLP-1 receptor antagonist in a Phase 3 trial for post-bariatric hypoglycemia (PBH), with topline data expected in the second half of 2026. Additionally, AMX0114, an antisense oligonucleotide targeting ALS, is in a Phase 1 trial, and AMX0035 continues to be evaluated in Wolfram syndrome (Phase 2) and progressive supranuclear palsy (Phase 2/3). The company's ability to advance these candidates while managing the financial impact of the ALS withdrawal will be key to its turnaround.

Upcoming Catalysts (preview)

• H2 2026Avexitide Phase 3 Topline Results for Post-Bariatric Hypoglycemia60% success
• H2 2026AMX0114 Phase 1 Initial Safety and Biomarker Data50% success
• H2 2026AMX0035 Phase 2 Data in Wolfram Syndrome30% success