Geron shares surge after U.S. FDA approves blood disorder drug (updated)

Geron

07/06/2024 11:34

(Adds background throughout, updates share move)
       June 7 (Reuters) - Shares of Geron  GERN.O  rose more
than 16% on Friday before markets opened, a day after the
biopharmaceutical company got its first approval from the U.S.
Food and Drug Administration for its blood disorder drug Rytelo.
    The injectable drug will compete with Bristol Myers Squibb's
 BMY.N  Reblozyl, which received a label expansion green light
by the regulator last year for the same disease indication.
    California-based Geron said it will discuss the new drug's
pricing and availability in a conference call with investors
later in the day.   
    Rytelo is approved for the treatment of
transfusion-dependent anemia in adults with low-risk
myelodysplastic syndromes - a group of blood cancers where blood
cells in the bone marrow do not mature or become healthy blood
cells, Geron  said in a statement late on Thursday.
    The approval was based on a late-stage study where nearly
40% of the patients on the drug showed independence from
transfusion for eight weeks, compared with 15% of patients on
placebo.
    Last year in January, Geron's CEO John Scarlett told Reuters
that the company anticipates a peak market potential of $1.2
billion for the treatment in the United States and some key EU
countries by 2030.
    In March, independent advisers to the FDA backed the
benefits of the drug, saying it outweighed its risks.
    Geron shares were up 16.7% to $4.54 in trading before the
bell.  

 (Reporting by Sriparna Roy and Christy Santhosh and Pratik Jain
in Bengaluru; Editing by Nivedita Bhattacharjee)
 ((Sriparna.Roy@thomsonreuters.com;))