Mycovia Pharmaceuticals Completes Successful Pre-NDA Meeting with FDA for Oteseconazole for the Treatment of Recurrent Vulvovaginal Candidiasis

– Mycovia on track to report topline results from Phase 3 VIOLET studies in fourth quarter 2020 –

Durham, N.C. – November 12, 2020 – Mycovia Pharmaceuticals, Inc. (“Mycovia”), an emerging biopharmaceutical company dedicated to recognizing and empowering those living with unmet medical needs by developing novel therapies, today announced the successful completion of its pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA) for its oral antifungal product candidate oteseconazole (VT-1161) for the treatment of recurrent vulvovaginal candidiasis (RVVC). The purpose of the meeting was to discuss and align on the clinical, non-clinical and chemistry, manufacturing and controls (CMC) requirements for Mycovia’s planned NDA submission.