Mesoblast soars on U.S. FDA's nod to review lead drug candidate

Mesoblast

08/03/2023 05:03

March 8 (Reuters) - Shares of Australia's Mesoblast Ltd
 MSB.AX  rallied more than 23% on Wednesday after the U.S. Food
and Drug Administration (FDA) agreed to review the company's
lead drug candidate on a priority basis, more than two years
after first rejecting it.
    The drug, remestemcel-L, is an investigational therapy to
treat children suffering from complications after bone marrow
transplants to treat blood cancers and other conditions.
    There are no approved treatments for the disease in the
United States for children under 12, making Mesoblast's therapy
an urgent need for a disease with low survival rates.
    The FDA said it considered Mesoblast's resubmitted biologics
license application as a "complete response" and that it would
fast-track remestemcel-L's review process.
    The U.S. health regulator said it would make its decision by
Aug. 2, which Jefferies said was in line with its estimates.
    The brokerage said it expects "significant" U.S. sales of
the drug in fiscal 2024.
    Mesoblast's shares were up about 15% at 0456 GMT, easing
from a jump of as much as 23.2% to a one-month-high of A$1.140
earlier in the session.

 (Reporting by Savyata Mishra in Bengaluru; Editing by Savio
D'Souza)
 ((Savyata.Mishra@thomsonreuters.com;))