ACER - Acer Therapeutics reaches agreement with FDA on protocol for phase 3 Edsivo trial

Acer Therapeutics (NASDAQ:ACER) reached an agreement with the U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) for its phase 3 study of its experimental therapy Edsivo (celiprolol) for the treatment of patients with COL3A1-positive vascular Ehlers-Danlos Syndrome, an inherited disorder that affects the connective tissues supporting the skin, joints and blood vessels. ACER stock -1.9% to $2.05 in Monday premarket trading. The SPA is a process through which a company or trial sponsor may seek an agreement with the FDA on the design and size of certain clinical trials. "Agreement on Acer’s Phase 3 trial design indicates concurrence by FDA with the adequacy and acceptability of specific critical elements of the overall protocol design that could support a future regulatory submission and marketing application...," the company said. ACER stock had gained in April after the FDA had granted Edsivo a Breakthrough Therapy designation.

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Acer Therapeutics reaches agreement with FDA on protocol for phase 3 Edsivo trial