Amylyx Drug Slows ALS Progression, Filings Imminent
Small Private Firm Plans To Commercialize On Its Own
Amylyx has raised just $75m to date, but that was enough to develop AMX0035 through a Phase II/III trial in which the drug slowed the progression of amyotrophic lateral sclerosis versus placebo.
You may also be interested in...
Private Company Edition: BioGeneration closed a €105m ($119m) fund to continue backing new European companies, while Samsara BioCapital, Evotec and KCK Ltd. launched the virtual incubator Autobahn Labs. Also, Poseida, Annexon and Goldfinch close $100m-plus VC rounds.
ALS advocates succeed in getting the FDA to soften its stance on use of randomized, placebo-controlled trials for drug development; final guidance also encourages patient-reported outcomes.
The arrival of the first drug for ALS in more than 20 years in the US will also be a boost to its originator Mitsubishi Tanabe's American ambitions.