Mesoblast (ASX:MSB) received a biologics license application (BLA) filing number from the US Food and Drug Administration (FDA) for rexlemestrocel-L in the prevention of gastrointestinal bleeding due to right ventricular dysfunction in end-stage heart failure patients with a left ventricular assist device, according to a Wednesday filing with the Australian bourse.
BLA filing number is a six-digit tracking number issued by the FDA to identify and monitor a formal request to market a biologic product.
The company also requested a modular review of its BLA for the therapy, the filing said.
Shares rose 3% in morning trade on Wednesday.