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Signs Of Life In The Bacterial Vaginosis, Vulvovaginal Candidiasis Pipeline

Executive Summary

Scynexis highlights enrollment exceeding expectations in Phase III VVC trials; Daré prepares to enter Phase III to treat BV.

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Filing Imminent As Mycovia’s Antifungal Prevents Recurrent Vulvovaginal Candidiasis

Oteseconazole prevented recurrent VVC in two Phase III studies but Phase III data in acute treatment of VVC episodes in women with RVVC, also due this month, are needed to file for US FDA approval in the first half of 2021.

Scynexis Prepares For NDA Filing With Second Phase III Success In VVC

Novel antifungal ibrexafungerp, a first-in-class triterpenoid, demonstrates ability to clear vulvovaginal candidiasis infections in second pivotal study; firm also looks to demonstrate efficacy in recurrent infections.

Scynexis’ Phase III Success Brings New Antifungal Class Closer To Approval

Biotech plans to file its first-in-class triterpenoid agent for approval in 2020 following a second Phase III study in acute vulvovaginal candidiasis. Beyond that, it hopes for a supplemental approval in recurrent VVC.

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