Amylyx Awaits Phase 3 Avexitide Data and Pipeline Updates

Amylyx is heading into a pivotal stretch as it prepares to report first quarter earnings on May 7. Pivotal topline data from the Phase 3 LUCIDITY study, which is testing avexitide in post-bariatric hypoglycemia, are due in the third quarter, and primary completion of LUCIDITY was estimated to be in March, with study completion expected in October.

Amylyx took a seismic hit when amyotrophic lateral sclerosis drug Relyvrio was pulled from U.S. and Canadian markets in April 2024 after it failed a Phase 3 trial. The move honored a pledge the co-CEOs had made to an advisory committee, sent Amylyx’s stock tumbling and around 70% of the company’s employees out the door.

Three months later, Amylyx announced in July 2024 the acquisition of a Phase 3-ready glucagon-like peptide-1 receptor antagonist, avexitide, from Eiger BioPharmaceuticals. This summer, Amylyx will learn if the diversification gamble was worth it.

The firm will also be watching for updates on next steps for Amylyx’s Phase 3 study of AMX0035 in Wolfram syndrome and expectations ahead of biomarker data from a Phase 1 study of AMX0114 in ALS, which are expected in the first half of this year. The company announced positive long-term results from the Phase 2 open-label Helios trial of AMX0035 in Wolfram in May 2025.