Benzinga | Jun 2, 2021 09:07AM EDT

Scynexis Scores FDA Nod For Brexafemme, Oral Treatment For Vaginal Yeast Infection

* The FDA has approved Scynexis Inc's (NASDAQ:SCYX) Brexafemme (ibrexafungerp tablets) for oral use in patients with vulvovaginal candidiasis (VVC), also known as a vaginal yeast infection.

* Brexafemme represents the first approved drug in a novel antifungal class in more than 20 years and is the first and only treatment for vaginal yeast infections, both oral and non-azole.

* The approval is based on positive results from two Phase 3 studies in which oral ibrexafungerp demonstrated efficacy and a favorable tolerability profile in women with VVC.

* Scynexis has partnered with Amplity Health to support the U.S. commercialization of Brexafemme, with a commercial launch scheduled in the second half of 2021.

* The company will host a conference call today at 8:30 a.m. ET.

* Price Action: SCYX shares were up 0.80% at $10.05 in the premarket session on the last check Wednesday.