FDA Denies Accelerated Approval for Clene’s ALS Candidate

Clene revealed Thursday that the FDA has decided not to grant accelerated approval for the company’s amyotrophic lateral sclerosis drug candidate.

The FDA in a recent meeting with Clene determined that the biomarker Neurofilament Light Chain (NfL) reduction findings in Phase II programs “were insufficient to support accelerated approval at this time,” according to the company’s announcement. Clene’s stock tumbled 33% in premarket trading Thursday in response to the news.