Mesoblast Shares Jump After FDA Nod for Submission of Remestemcel-L Application
By Dean Seal
Mesoblast's American depositary receipts surged after the company got the go-ahead from regulators to submit a biologics license application for its remestemcel-L treatment for pediatric patients with a life-threatening complication of stem cell transplants.
The stock was up 25% at $2.75 in premarket trading. Shares were flat year-to-date when the market closed Monday and were trading at around $6.18 this time a year ago.
The Food and Drug Administration has informed Mesoblast that after additional consideration, the available clinical data from its Phase 3 study is sufficient to support the submission of a proposed biologics license application for remestemcel-L as a treatment for pediatric patients with steroid-refractory acute graft versus host disease.
Acute graft versus host disease is a potentially life-threatening complication of a stem cell transplant from a donor but remestemcel-L is aimed at patients who are resistant to treatment with steroids after a transplant.
Mesoblast said it intends to file the resubmission during the next quarter and will aim to address all remaining product characterization issues.
Write to Dean Seal at dean.seal@wsj.com
(END) Dow Jones Newswires
March 26, 2024 08:29 ET (12:29 GMT)
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