Acer Therapeutics Announces FDA Acceptance of NDA and Priority Review for EDSIVO™ for the Treatment of vEDS
Acer Therapeutics Inc. (ACER)
Last acer therapeutics inc. earnings: 3/18 04:05 pm
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Source: GlobeNewswire
Acer continues progress toward goal of commercializing EDSIVO™ NEWTON, Mass., Dec. 26, 2018 (GLOBE NEWSWIRE) -- Acer Therapeutics Inc. (Nasdaq: ACER), a pharmaceutical company focused on the acquisition, development and commercialization of therapies for serious rare and ultra-rare diseases with critical unmet medical need, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review Acer’s New Drug Application (NDA) for EDSIVO™ for the treatment of vascular Ehlers-Danlos syndrome (vEDS) in patients with a confirmed type III collagen (COL3A1) mutation. The FDA also granted a priority review of the NDA and assigned a Prescription Drug User Fee Act (PDUFA) target action date of June 25, 2019. Priority review is a designation granted by the FDA to accelerate the review process for drugs that offer a significant improvement in treatment or provide treatment where no satisfactory alternative therapy exists. “The acceptance of our NDA for EDSIVO™ is an import
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