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

The FDA has approved Scynexis Inc's 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.