Amylyx Pharmaceuticals, Inc. has announced the start of a process with the FDA and Health Canada to voluntarily discontinue the marketing authorizations for their product, RELYVRIO/ALBRIOZA, and remove it from the market in the U.S. and Canada. This decision is based on the topline results from the Phase 3 PHOENIX trial of AMX0035 for the treatment of Amyotrophic lateral sclerosis.
In addition to this, the company also announced a major restructuring plan. This includes reducing the workforce by approximately 70%, and decreasing external financial commitments that fall outside of the company's priority areas. With these changes, Amylyx expects that their cash runway will reach into 2026.
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