FDA approves Amylyx's RELYVRIO for ALS; Phase 2 trial showed slowed physical decline

Amylyx Pharmaceuticals, Inc.

FDA approved RELYVRIO (AMX0035) for adults with ALS based on Phase 2 CENTAUR trial in 137 participants that met primary efficacy endpoint.
RELYVRIO significantly slowed loss of physical function vs placebo; can be used as monotherapy or with existing ALS treatments.
Amylyx priced RELYVRIO below the latest FDA-approved ALS product; expects specialty pharmacies to start filling prescriptions within 4-6 weeks.
Most common adverse events (>=15% and >=5% over placebo) were diarrhea, abdominal pain, nausea, and upper respiratory tract infection.
Management to host investor conference call Sept 30 at 8:00 AM ET to discuss approval and commercial plans.

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