Acer Therapeutics Axes 60% of Workforce after FDA Rebuff

Genengnews | July 05, 2019

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.

Spotlight

Although R&D spending on new drugs is high and the number of new INDs for small molecules and biologics continues to increase each year, the number of NDAs/BLAs submitted and approved by FDA has remained on average steady over the last 10 years.

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Spotlight

Although R&D spending on new drugs is high and the number of new INDs for small molecules and biologics continues to increase each year, the number of NDAs/BLAs submitted and approved by FDA has remained on average steady over the last 10 years.