MSB Mesoblast Limited

By Chris Wack

Mesoblast Ltd. shares were up 10% to $2.80 after the company said it submitted substantial new information to the U.S. Food and Drug Administration on clinical and potency assay items identified in a Complete Response Letter from FDA.

The company said the CRL was received in September 2020 in response to the Biologics License Application for remestemcel-L in the treatment of children with steroid-refractory acute graft versus host disease.

Mesoblast has maintained an active dialog with the FDA since receiving the CRL, and the new information submitted to the Investigational New Drug file for remestemcel-L in the treatment of children with SR-aGVHD, as guided by FDA, represents a major milestone in its complete response to the FDA.

Remestemcel-L has been granted Fast Track Designation and BLA Priority Review from the FDA.

Write to Chris Wack at chris.wack@wsj.com

(END) Dow Jones Newswires

October 03, 2022 12:58 ET (16:58 GMT)

Mesoblast (ASX:MSB)
Historical Stock Chart
From Jan 2025 to Feb 2025

Mesoblast (ASX:MSB)
Historical Stock Chart
From Feb 2024 to Feb 2025