Bloomberg Law
Free Newsletter Sign Up
Bloomberg Law
Welcome
Go
Free Newsletter Sign Up

Phasebio Launches Clinical Trial for Covid-19 Treatment

May 27, 2020, 8:07 PM

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

To view the source of this information click here

To contact the reporter on this story:
Sebastian Tong in San Francisco at stong41@bloomberg.net

To contact the editor responsible for this story:
Angela Moon at hmoon43@bloomberg.net

© 2020 Bloomberg L.P. All rights reserved. Used with permission.