MESO) shares are trading higher after the company announced the Oncologic Drugs Advisory Committee of the FDA voted in favor of its RYONCIL for efficacy in children with steroid-refractory acute graft versus host disease.
RYONCIL has been accepted for Priority Review by the FDA with an action date of Sept. 30, under the Prescription Drug User Fee Act (PDUFA). If approved by the PDUFA date, Mesoblast plans to launch RYONCIL in the United States in 2020.
Mesoblast is a small-cap biotech company with listings on both the ASX and the Nasdaq. The company has acquired the rights to develop and commercialize certain regenerative medicine technologies aimed at innovative ways of treating inflammatory diseases.
Mesoblast was trading 44.24% higher at $17.03 at time of publication. The stock has a 52-week high of $20.57 and a 52-week low of $3.12.
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