The Mesoblast limited (ASX: MSB) share price has been a positive performer on Wednesday morning.
At the time of writing the cellular medicines developer's shares are up 12% to $1.55.
Why is the Mesoblast share price storming higher?
Investors have been buying Mesoblast's shares after it provided an update on its RYONCIL product.
RYONCIL (remestemcel-L) is the company's lead product candidate. It is an investigational therapy comprising culture-expanded mesenchymal stem cells derived from the bone marrow of an unrelated donor.
It is administered to patients in a series of intravenous infusions and is believed to have immunomodulatory properties to counteract the inflammatory processes that are implicated in steroid-refractory acute graft versus host disease (SR- aGVHD).
This is by down-regulating the production of pro-inflammatory cytokines, increasing production of anti-inflammatory cytokines, and enabling the recruitment of naturally occurring anti-inflammatory cells to involved tissues.
What was today's update?
This morning Mesoblast announced that the U.S. Food and Drug Administration (FDA) has accepted its application for the priority review of its Biologics License Application (BLA) filing for RYONCIL for the treatment of children with SR- aGVHD.
According to the release, the FDA has set a Prescription Drug User Fee Act action date of September 30. If approved, Mesoblast will make RYONCIL immediately available in the United States.
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."
