Acer Therapeutics decimated, as FDA stalls Edsivo approval

US rare diseases drug develop Acer Therapeutics (Nasdaq: ACER) saw its market capitalization shattered after the company said it had received a Complete Response Letter (CRL) from the US Food and Drug Administration regarding its New Drug Application (NDA) for Edsivo (celiprolol) for the treatment of vascular Ehlers-Danlos syndrome (vEDS).

The CRL states that it will be necessary to conduct an adequate and well-controlled trial to determine whether celiprolol reduces the risk of clinical events in patients with vEDS, a rare genetic disorder. Acer plans to request a meeting to discuss the FDA’s response.

Such a trial is likely to require several years for execution, commented William Blair analyst Tim Lugo.