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Monday 4th of April 2022 06:12:25 AM

Acer gains on FDA’s Breakthrough status for Edsivo in genetic disorder

Headquarters of US Food and Drug Administration (FDA) Grandbrothers/iStock Editorial via Getty Images
  • The clinical-stage pharma company, Acer Therapeutics (NASDAQ:ACER), has added ~27% in the pre-market Monday after announcing that the U.S. Food and Drug Administration (FDA) granted the Breakthrough Therapy designation for experimental therapy, celiprolol.
  • The Breakthrough designation for celiprolol covers its application as a treatment for COL3A1-positive vascular Ehlers-Danlos syndrome (vEDS), an inherited disorder characterized by mutations in the genes responsible for collagen.
  • FDA’s Breakthrough Therapy designation is aimed at speeding up the development and review of treatments targeted at serious or life-threatening conditions. With all features of the designation, a developer can receive intensive regulatory guidance with potential eligibility for priority review from the FDA.
  • Acer (ACER) plans to start its pivotal Phase 3 DiSCOVER trial for the therapy in 2Q 2022, subject to an agreement with the FDA on the trial design. The U.S.-based study, involving approximately 150 COL3A1-positive vEDS patients, is likely to take nearly 3.5 years to complete.
  • With over 24% rise in value in the year so far, Acer (ACER) has managed to hold on to its Buy rating on Wall Street this year.

ACER

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