(Reuters) – Shares of Australia’s Mesoblast Ltd 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)
