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

03-26-24 0829ET