PHAS - PhaseBio to seek FDA approval for clotting agent in 4Q 2022

The clinical-stage biotech PhaseBio Pharmaceuticals (NASDAQ:PHAS) announced on Monday its plans to submit the U.S. marketing application for the company’s experimental clotting agent bentracimab in 4Q 2022. Following a Pre-BLA Meeting conducted in early April, the company has received formal written minutes from the FDA. It suggests the agency’s willingness to accept a Biologics License Application (BLA) for bentracimab potentially supporting a label with both surgical and uncontrolled bleeding indications, the company said. A human monoclonal antibody, bentracimab is currently undergoing a global Phase 3 trial named REVERSE-IT to evaluate its effect in the reversal of antiplatelet effects of cardiovascular therapy ticagrelor in patients with bleeding or who require urgent surgery or invasive procedure. The company has completed the enrollment of the surgical patients and 35 uncontrolled bleeding patients in the REVERSE-IT, PhaseBio (PHAS) added.

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PhaseBio to seek FDA approval for clotting agent in 4Q 2022