Controversy over Genervon’s ALS drug GM604 study

A very small study for privately-held US firm Genervon Biopharmaceuticals’ amyotrophic lateral sclerosis (ALS) drug GM604 has raised questions about the data that were provided by the company, which has aroused an angry campaign by ALS patients to gain an accelerated FDA approval.

Genervon's 12-person study, with four people assigned to a placebo arm, assessed the drug's performance on several biomarkers for the disease, which would not be sufficient to gain an accelerated approval.