Mesoblast Shares Rise 11% After Resubmitting Biologics License Application
February 01 2023 - 12:22PM
Dow Jones News
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)
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