Business
SCYNEXIS Reports Third Quarter 2020 Financial Results and Provides Company Update
In October, SCYNEXIS submitted a New Drug Application (NDA) for ibrexafungerp for the treatment of vulvovaginal candidiasis (VVC) with expected approval in
About this update from Scynexis, Inc.
[{"type":"text","content":"In October, SCYNEXIS submitted a New Drug Application (NDA) for ibrexafungerp for the treatment of vulvovaginal candidiasis (VVC) with expected approval in mid-2021. SCYNEXIS estimates that there are over 15 million antifungal prescriptions written each year for the treatment of VVC.Enrollment is ongoing in the Phase 3 CANDLE study of oral ibrexafungerp for the prevention of recurrent vaginal yeast infections; top-line results and a second NDA submission anticipated in the second half of 2021.Enrollment continues in clinical studies of oral ibrexafungerp for the treatment of serious and life-threatening fungal infections, including those caused by drug-resistant Candida auris, recognized by the CDC as an urgent threat to public health. JERSEY CITY, N.J., Nov. 06, 2020 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to potentially overcome and prevent difficult-to-treat and drug-resistant infections, today reported financial results for the third quarter ended on September 30, 2020 and provided an update on recent clinical and corporate developments.\n “We submitted our NDA for ibrexafungerp for the treatment of vaginal yeast infections ahead of schedule and, with approval anticipated in mid-2021, we continue to progress towards our transition into a fully integrated commercial-stage antifungal company with an initial focus on women’s health,” said Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS. “In parallel, we are also advancing clinical trials evaluating ibrexafungerp’s potential to treat invasive fungal infections in the hospital setting, with additional data read-outs expected in 2021.” Ibrexafungerp Update SCYNEXIS recently announced the submission of its NDA to the U.S. Food and Drug Administration (FDA) for oral ibrexafungerp for the treatment of VVC, also known as vaginal yeast infection. The submission occurred in October and SCYNEXIS expects to receive FDA feedback on the acceptability of this submission in December. As a qualified infectious disease product (QIDP), ibrexafungerp is expected to receive a six-month priority review following NDA acceptance with a PDUFA date anticipated in mid-2021. Enrollment is ongoing in the Phase 3 CANDLE study, investigating the efficacy and safety of oral ibrexafungerp for the prevention of recurren...