The Mesoblast Limited (ASX: MSB) share price is starting the year on a positive note.
In morning trade the cellular medicines developer's shares are up 3% to $2.15. This leaves them trading within a few cents of their 52-week high.
Why is the Mesoblast share price charging higher?
Investors have been buying Mesoblast's shares following an update on its remestemcel-L candidate.
According to the release, the U.S. Food and Drug Administration (FDA) has confirmed receipt of its filing of clinical efficacy and safety data for remestemcel-L. This is in relation to its rolling Biologics License Application (BLA) for the treatment of children with steroid-refractory acute graft versus host disease (SR-aGVHD).
The final module will be filed during January. After which, Mesoblast will request an expedited FDA review of the BLA under its existing Fast Track designation. This means that remestemcel-L could be launched commercially in the United States in 2020 if the FDA approve it.
And it looks increasingly likely that the product candidate will be approved. The release explains that study results demonstrate the effectiveness of remestemcel-L in this patient population. It notes a particular efficacy and survival benefit in patients with the most severe forms of aGVHD.
These conclusions are supported by prior results from an Expanded Access Program in 241 children where remestemcel-L was used as salvage therapy after failure of steroids and other agents.
What is Acute GVHD?
Acute GVHD is a potentially life-threatening condition which occurs in about 50% of patients who receive an allogeneic bone marrow transplant.
More than 30,000 patients worldwide receive an allogeneic bone marrow transplant. This is primarily during treatment for blood cancers, and 20% to 25% of these patients are children. There are currently no approved treatments in the US for children under 12.
Mesoblast's Chief Medical Officer, Dr Fred Grossman, said: "We are pleased to have submitted to the FDA clinical efficacy and safety data for remestemcel-L, as well as comparative clinical outcome data from contemporaneous controls. We are working closely with the FDA to make our cellular medicine available and improve outcomes in children with this devastating condition."
