Clene down after FDA says ALS drug data insufficient for accelerated approval

Clene

21/12/2023 12:36

** Shares of Clene  CLNN.O  down 22.3% to $0.4 before the
bell
    ** CLNN met with U.S. FDA to discuss its experimental ALS
treatment, presenting initial clinical and complete data from a
mid-stage study 
    ** FDA determined the initial findings of biomarker NfL
reductions from the study were insufficient to support
accelerated approval at this time
    ** Nfl or Neurofilament protein is a marker of nerve cell
degeneration
    ** Clene said it will provide FDA with supplemental data in
the first half of 2024 for further engagement
    ** Supplemental data will include additional long-term
clinical evidence and biomarker results of the treatment's
benefit in people living with ALS
    ** Amyotrophic lateral sclerosis (ALS) affects nerve cells
in the brain and spinal cord, causing loss of muscle control
    ** Up to Wednesday's close, stock had fallen ~49% YTD

 (Reporting by Khushi Mandowara in Bengaluru)
 ((Khushi.Mandowara@thomsonreuters.com;))