SCYNEXIS Gets Orphan Drug Status For Its SCY-078

SCYNEXIS, Inc.

revealed that the FDA has granted orphan drug designation to its novel and structurally distinct glucan synthase inhibitor, SCY-078. According to the company, the drug is for the treatment of invasive Candida infections, including candidemia. SCYNEXI said that the orphan drug designation provided seven years of market exclusivity. Previously, it was granted Qualified Infectious Disease Product (QIDP) designation, which provided an additional five years of exclusivity. The company indicated that these designations provided together SCYNEXIS with a potential twelve years of market exclusivity in the U.S. after FDA approval. The company's President and CEO, Marco Taglietti, said, "We are pleased with FDA's decision to grant SCY-078 orphan drug designation which speaks to the urgent need for a new class of antifungal agents to treat this rare and life-threatening condition, particularly as resistance to current treatments continues to rise." He continued to say that, "This latest achievement is another key milestone for SCYNEXIS and we look forward to announcing top line data from our two ongoing Phase 2 studies of SCY-078's oral formulation for the treatment of vulvovaginal candidiasis (VVC) and invasive candidiasis in June and July 2016, respectively." Apart from the potential extended market exclusivity in the specified indication in the United States, if SCYNEXIS complied with some FDA requirements, then the designation provided several other benefits and incentives. That included tax credits related to qualified clinical trial expenses and an exemption from FDA application fees. On Thursday, the stock traded 3.15% down.