By Chris Wack

Mesoblast Ltd. shares were up 11% to $3.67 Wednesday after the company said it resubmitted a biologics license application to the U.S. Food and Drug Administration seeking approval of remestemcel-L, a treatment for pediatric steroid-refractory acute graft versus host disease.

The New York company, which develops cellular medicines to treat severe and life-threatening inflammatory conditions, said the resubmission contains substantial new information required by the FDA in a September 2020 complete response letter. Upon acceptance by the FDA, the resubmitted BLA will have up to a six-month review period from its filing.

Mesoblast said it has maintained an active dialogue with the FDA since receiving the complete response letter and that it provided in October a high-level synopsis of the added BLA information in an investigational new drug application for remestemcel-L.

The FDA has granted remestemcel-L a fast track designation and a priority review designation.

Mesoblast shares are down 13% over the past 12 months.

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

(END) Dow Jones Newswires

February 01, 2023 12:07 ET (17:07 GMT)

Copyright (c) 2023 Dow Jones & Company, Inc.
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