May. 7 at 7:32 PM
$BCLI $CLNN
Part 3
In 2023, the FDA granted accelerated approval to a Biogen drug, called Qalsody, for a rare genetic type of ALS based on a 55% reduction in plasma neurofilament. The FDA concluded that significant and meaningful reductions in neurofilament were reasonably likely to predict clinical benefit for patients.
In its clinical trials, Clene’s CNM-Au8 reduced plasma neurofilament by 2%-3%, depending on the time period measured, according to the company.
On Monday, Clene announced a plan to submit a marketing application for CNM-Au8 to the FDA in the third quarter. In a press release, Clene said it had a “successful” meeting with the FDA, at which regulators told the company that its “proposed data may be capable of supporting the submission and review” of a marketing application seeking accelerated approval of CNM-Au8 for the treatment of ALS, Clene said.