FDA Commentary Sends Biotech Soaring During Premarket Hours - InvestingChannel

FDA Commentary Sends Biotech Soaring During Premarket Hours

A biotech stock that has seen some pretty wild price swings as of late is turning heads so far during Tuesday’s premarket after the company was notified by the U.S. FDA that available clinical data from Phase 3 trial appeared sufficient to support BLA submission for Remestemcel-L in children with Steroid-Refractory Acute Graft Versus Host Disease (SR-aGVHD), according to an earlier press release.

While the news was rather technical in nature, the bottom line is that traders reacted toward the bullish side of things, with shares of Mesoblast Limited (Nasdaq:MESO) currently bid up at $3.03/share (+37.73% implied open for sellers) at the time of writing. It should be an exciting session for this small cap!

Mesoblast Ltd is a clinical-stage biotechnology company. It develops and commercializes innovative allogeneic cellular medicines to treat complex diseases resistant to the conventional standard of care. Its portfolio of Phase 3 product candidates comprises remestemcel-L for the treatment of steroid-refractory acute graft versus host disease (SR-aGVHD), and for moderate to severe acute respiratory distress syndrome (ARDS) and others.

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