Mesoblast ADSs Rally as FDA Accepts Remestemcel-L Resubmission

By Colin Kellaher

American depositary shares of Mesoblast Ltd. jumped more than 15% in early trading Wednesday after the biopharmaceutical company said the U.S. Food and Drug Administration accepted its resubmitted application seeking approval of its remestemcel-L drug candidate.

The Melbourne, Australia, company said the FDA considers the resubmission to be a complete response to the agency's prior rejection of remestemcel-L and set a target action date of Aug. 2.

Mesoblast is seeking approval of remestemcel-L in children with steroid-refractory acute graft-versus-host disease, a potentially life-threatening complication of an allogeneic bone-marrow transplant for blood cancer.

The FDA in late 2020 turned away the application and called on the company to conduct another study even though an FDA advisory committee had recommended approval of the drug. The FDA usually follows the advice of its advisory committees.

Mesoblast in late January said it had resubmitted its application with substantial new information requested by the FDA.

Mesoblast ADSs were recently changing hands at $3.52, up 16%. The company's Australia-listed shares ended Wednesday's session with a gain of 14%.

Write to Colin Kellaher at [e-mail]

(END) Dow Jones Newswires

March 08, 2023 10:36 ET (15:36 GMT)

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