ACER - Acer gains on FDA's Breakthrough status for Edsivo in genetic disorder

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 in the treatment of patients with 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 Fast Track designation features, it can also allow a developer to receive intensive guidance from the regulator with potential eligibility for priority review. 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 trial involving approximately 150 COL3A1-positive vEDS patients is likely to take nearly 3.5

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