Business
SCYNEXIS Reports Second Quarter 2020 Financial Results and Provides Company Update
In July, SCYNEXIS announced that it had successfully conducted pre-NDA meetings with the FDA regarding ibrexafungerp for the treatment of Vulvovaginal
About this update from Scynexis, Inc.
[{"type":"text","content":"In July, SCYNEXIS announced that it had successfully conducted pre-NDA meetings with the FDA regarding ibrexafungerp for the treatment of Vulvovaginal Candidiasis (VVC) more commonly known as vaginal yeast infection. NDA submission for this indication remains on track for Q4 2020.\n In July, SCYNEXIS held an investor event with two key opinion leaders (KOLs) to discuss patient perspectives, unmet needs and treatment options in VVC, as well as the related commercial opportunity. This event followed the successful completion of the Phase 3 VANISH program evaluating oral ibrexafungerp 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 supplemental NDA submission anticipated in the second half of 2021. JERSEY CITY, N.J., Aug. 10, 2020 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug resistant infections, today reported financial results for the quarter ended on June 30, 2020 and provided an update on recent clinical and corporate developments. “We have recently achieved some key milestones with the successful completion of our pivotal VANISH Phase 3 program evaluating oral ibrexafungerp for the treatment of vaginal yeast infections, followed by productive pre-NDA meetings with the FDA,” said Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS. “In both our VANISH Phase 3 trials, ibrexafungerp treatment resulted in clinically meaningful improvement and statistically significantly greater cure rates when compared to placebo, and we remain on track to submit our NDA for the treatment of vaginal yeast infections in the fourth quarter of this year, setting us up for a potential regulatory approval in mid-2021. I am extremely proud of our team’s commitment to advancing this program as we transition SCYNEXIS to a fully integrated drug development and commercial company with an initial focus on vaginal yeast infections.” Ibrexafungerp Update Ibrexafungerp achieved superiority over placebo with a high degree of statistical significance on key study endpoints required for regulatory approval for the treatment of VVC in both VANISH pivotal trials. The two VANISH studies are among the first p...