PhaseBio Pharmaceuticals Inc. gets FDA authorization to proceed with VANGARD, a potentially pivotal clinical trial to evaluate PB1046 as a treatment for hospitalized COVID-19 patients who are at high risk for rapid clinical deterioration and acute respiratory distress syndrome (ARDS).
- Company gets clearance of IND application from U.S. FDA under Coronavirus Treatment Acceleration Program (CTAP)
- “VANGARD” trial will assess the efficacy and safety of PB1046 in hospitalized COVID-19 patients at high risk for rapid clinical deterioration and acute respiratory distress syndrome
- Based on FDA feedback, PhaseBio believes that positive, clearly interpretable and clinically meaningful trial results may enable PhaseBio to submit a Biologics License Application: statement
- PhaseBio shares up 36% after close
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