Amylyx stock gains as it pulls ALS therapy Relyvrio

Amylyx Pharmaceuticals (NASDAQ:AMLX) on Thursday formally announced its decision to withdraw Relyvrio, an FDA-approved therapy for the neurodegenerative disease, amyotrophic lateral sclerosis (ALS), following a Phase 3 setback.

The Cambridge, Massachusetts-based biotech has already started discussions with regulators to voluntarily discontinue the marketing authorizations for the drug in the U.S. and Canada, where Relyvrio is known as Albrioza.

“Relyvrio/Albrioza will no longer be available for new patients as of today,” the company noted. Its decision follows the failure of its Phase 3 PHOENIX trial for Relyvrio, also known as AMX0035, last month.

However, the company will continue to study AMX0035 in rare neurodegenerative conditions, Wolfram syndrome, and progressive supranuclear palsy. Interim data from its Phase 2 HELIOS study for AMX0035 in Wolfram syndrome is expected later this month.

Its Phase 3 ORION study to evaluate AMX0035 for progressive supranuclear palsy is ongoing, with its early data expected in mid-2025. Meanwhile, Amylyx (AMLX) plans to start a clinical study in H2 2024 to test its antisense oligonucleotide AMX0114 in ALS.

With Relyvrio off the market, the company announced a restructuring program to shed about 70% of its workforce and extend its cash runway into 2026.