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Amylyx Pharmaceuticals Receives FDA Orphan Drug Designation for AMX0035 for the Treatment of Amyotrophic Lateral Sclerosis

Amylyx Pharmaceuticals, Inc., announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to AMX0035, an oral therapeutic in clinical development for the treatment of amyotrophic lateral sclerosis (ALS). The Company recently began a Phase 2 clinical study, the CENTAUR trial, to evaluate the safety and efficacy of AMX0035 in ALS patients.

Project ALS and Amylyx Enter Collaboration to Test AMX0035

Project ALS and Amylyx Pharmaceuticals today announced a collaboration to undertake pre-clinical studies with Amylyx’s oral compound AMX0035 to advance the understanding of the compound’s neurobiological effects. The studies to be conducted at the Project ALS Pre-Clinical Core at Columbia University’s Motor Neuron Center will complement the company’s recently initiated Phase 2 clinical program of AMX0035 for the treatment of amyotrophic lateral sclerosis (ALS).