Mesoblast shares tank after US FDA rejects cell therapy for children (updated)

Mesoblast

04/08/2023 05:36

(Changes dateline, adds share movement in paragraph 1 and 3)
       Aug 4 (Reuters) - The U.S. health regulator rejected
Mesoblast's  MSB.AX   MESO.O  cell therapy for children under 12
years of age for treating a type of complication that occurs
after a stem cell or bone marrow transplant, sending its
Australia-listed shares crashing about 58% on Friday.
    The U.S. Food and Drug Administration (FDA) required more
data to support marketing approval for the company's lead
product remestemcel-L, Mesoblast said in a statement on
Thursday.
    Mesoblast shares slumped as much as 58.3% when they opened
in Sydney, before marginally paring some losses to trade down
54.8% at A$0.49 by 0416 GMT.
    The rejection is a blow to Mesoblast's hopes for a potential
launch of the therapy, especially after its fundraising efforts
over the last two years.
    The drug developer was seeking the FDA's approval for a cell
therapy to treat children with a type of graft versus host
disease (GvHD), whose symptoms did not respond to standard
steroid therapy or developed recurrence while continuing
treatment.
    There are no approved therapies in children for the
condition in which the donor's bone marrow or stem cells attack
the recipient.
        

 (Reporting by Pratik Jain, Sriparna Roy and Shivani Tanna in
Bengaluru; Additional reporting by Juby Babu; Editing by Krishna
Chandra Eluri, Sherry Jacob-Phillips and Rashmi Aich)
 ((Pratik.Jain@thomsonreuters.com;))