2023-03-08 05:34:38 ET
The U.S. Food and Drug Administration (FDA) accepted to review Mesoblast's ( NASDAQ: MESO ) resubmitted application seeking approval of remestemcel-L to treat children with steroid-refractory acute graft versus host disease (SR-aGVHD), more than two years after it was initially rejected.
The FDA's Office of Therapeutic Products (OTP) accepted the company's refiled biologics license application (BLA) and the agency is expected to make a decision by Aug. 2.
"Over the last two years we have worked tirelessly to address the issues previously raised by FDA," said Mesoblast Chief Executive Silviu Itescu.
Mesoblast noted that the FDA considers the resubmission to be a complete response to the agency's requirement.
The Australian company said the refiling contains new long-term survival data through at least four years for children enrolled in a phase 3 trial, among other information.
"We look forward to working closely with the Agency over the review period with the aim to make remestemcel-L available as a therapy for children suffering from SR-aGVHD," Itescu added.
GVHD occurs following allogeneic stem cell transplant when the donor immune cells view the host's cells as a threat and attacks the host's tissues.
The company noted that the FDA had previously granted remestemcel-L fast track and priority review designations.
MESO +10.89% to $3.36 premarket March 8
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Mesoblast stock surges ~10% on getting FDA review of graft versus host disease therapy