|From: SunTzu772 (Rep: 1326)||Date: 04/01/2020 11:30|
|Forum: Wall Street Pit - Msg #2830597 - List MESO msgs ||Thread #674139051 (Rec: 0) |
|4.71 in here as well still seems under radars -|
FDA ACCEPTS MESOBLAST’S BIOLOGICS LICENCE APPLICATION FOR RYONCIL™ AND AGREES TO PRIORITY REVIEW
NEW YORK, April 01, 2020 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq: MESO; ASX:MSB), global leader in cellular medicines for inflammatory diseases, today announced that the United States Food and Drug Administration (FDA) has accepted for priority review the Company’s Biologics License Application (BLA) filing for RYONCILTM (remestemcel-L), its allogeneic cell therapy for the treatment of children with steroid-refractory acute graft versus host disease (SR-aGVHD). The FDA has set a Prescription Drug User Fee Act (PDUFA) action date of September 30, 2020, and if approved, Mesoblast will make RYONCIL immediately available in the United States.
A Priority Review designation will direct overall attention and resources to the evaluation of applications for drugs that, if approved, would be significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications. The FDA has advised that they are planning to hold an Advisory Committee Meeting to discuss this application.
Mesoblast Chief Executive Dr Silviu Itescu stated: “There is a critical need to improve survival outcomes in children suffering from the more advanced stages of this devastating disease. The acceptance of the BLA represents an important milestone for the Company. Mesoblast is on track in its preparation for the potential launch of RYONCIL, including meeting its target inventory build and commercial team roll-out.
------------------- "Opportunities multiply as they are seized" -- Sun Tzu circa 500 B.C. -------------------
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