Scynexis' Brexafemme For Vaginal Yeast Infections Secures 10 Years Regulatory Exclusivity

The FDA has granted five years of exclusivity extension under the Generating Antibiotic Incentives Now (GAIN) Act to Scynexis Inc's SCYX recently approved Brexafemme (ibrexafungerp tablets) for vaginal yeast infections or vulvovaginal candidiasis.
This exclusivity will be added to any other applicable exclusivity periods, such as the five years of new chemical entity exclusivity, for a combined ten-year period of regulatory exclusivity.
Brexafemme is also protected by multiple patents, including a composition-of-matter patent covering the ibrexafungerp molecule.
With patent term extension, this patent is expected to expire in 2035, providing 14 years of protection from generic competitors in the U.S.
The company will share additional commercialization plans on June 29.
Price Action: SCYX shares are up 0.60% at $8.38 during the market session on the last check Wednesday.