Acer Therapeutics Axes 60% of Workforce after FDA Rebuff

Acer Therapeutics said today it has eliminated about 60% of its workforce—29 jobs—and halted pre-commercialization activities for its lead candidate Edsivo™ (celiprolol) in a restructuring that comes two weeks after the FDA refused to approve Edsivo for a rare connective tissue disorder. The FDA has sent Acer a Complete Response Letter (CRL) stating it would not approve the company’s NDA for Edsivo in vascular Ehlers-Danlos syndrome (vEDS). The CRL directed Acer to “conduct an adequate and well-controlled trial to determine whether celiprolol reduces the risk of clinical events in patients with vEDS,” the company stated on June 25. As a result of the CRL, Acer said, its board decided to reduce operating expenses and conserve cash by cutting its workforce and ending pre-commercialization activities related to Edsivo. “The Company estimates that it will record a one-time severance-related charge of approximately $1.5 million associated with the workforce reduction in the second quarter of 2019,” Edsivo stated in a regulatory filing. Acer says it will be able to fund its planned business operations through 2020. The company finished the first quarter with $31.8 million in cash and cash equivalents, which Acer in May said was believed to be sufficient to fund current operating and capital requirements into the first half of next year.