FDA Asks Genervon to Release All Study Data for Experimental ALS Drug

The Food and Drug Administration said in an April 17 statement that it is asking Genervon Biopharmaceuticals LLC to release all data from its recently completed clinical trial for its experimental treatment for amyotrophic lateral sclerosis (ALS) called GM604.

There is no cure for ALS. The agency said it knows that ALS patients, their families and others in the ALS community are concerned about the status of GM604, and that it is making the request to allow a more informed discussion of the trial findings among stakeholders.

“Such a release should include the pre-specified outcome measures as assessed by change ...