US FDA finds Clene's trial data for ALS drug to be insufficient (updated)

Clene

21/12/2023 12:26

(Adds share movement in paragraph 2, details in paragraphs 3 to
5)
       Dec 21 (Reuters) - Clene  CLNN.O  said on Thursday that
the U.S. Food and Drug Administration (FDA) found data from the
company's mid-stage study for the treatment of a type of
neurodegenerative disease to be insufficient to support
accelerated approval.
        Shares of the company fell 20% in premarket trading.
  
        The FDA determined that the initial findings on
biomarker NfL reduction from the mid-stage studies were
insufficient.
  
        Nfl or Neurofilament protein is a marker of nerve cell
degeneration. Higher levels of the protein are considered a
predictor of a more rapid decline in clinical function and a
greater risk of death in patients.
  
        The company said that it is looking to provide
supplemental data for further engagement with the FDA in the
first half of 2024.
  
        
  

 (Reporting by Christy Santhosh; Editing by Shweta Agarwal)
 ((Christy.Santhosh@thomsonreuters.com;))