SCYNEXIS Shares Climb As FDA Accepts Filing For Vaginal Yeast Infection Candidate Under Priority Review

SCYNEXIS (NASDAQ: SCYX) announced that the U.S. Food and Drug Administration (FDA) has accepted its submission of a supplemental New Drug Application (sNDA) to expand the label of BREXAFEMME (ibrexafungerp tablets) to include the prevention of recurrent vulvovaginal candidiasis (RVVC).

The regulatory agency has granted Priority Review for the submission and assigned the target decision date as November 30, 2022.

The sNDA submission for the label extension is supported by positive data from the pivotal Phase 3 CANDLE study evaluated ibrexafungerp, successfully achieved statistically significant superiority over placebo for the primary and key secondary study endpoints.

Marco Taglietti, President and Chief Executive Officer, stated, “The FDA's acceptance of this submission is excellent news for patients, and it brings us another step closer to our vision of addressing significant unmet needs in women's health. Our pivotal CANDLE study was the basis of the sNDA submission, and we look forward to presenting details of these data to the medical community."

The company is scheduled to present CANDLE study results this week at the Infectious Diseases Society for Obstetrics and Gynecology (IDSOG) Annual Meeting being held in Boston.

The agency has designated ibrexafungerp as a qualified infectious disease product (QIDP), eligible for a six-month priority review.

Price Action : SCYNEXIS shares are trading around 4 percent higher at $2.40 on Monday at the time of publication.