Filing Imminent As Mycovia’s Antifungal Prevents Recurrent Vulvovaginal Candidiasis
Private Company Is Preparing For Commercialization, Talking To Partners
Executive Summary
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.
You may also be interested in...
Finance Watch: BioAtla, Virios And Scopus Launch Latest US IPOs
Public Company Edition: Initial public offerings may take a holiday break, but 2020 already has been a remarkable year for IPOs in the US and China. Also, Arvinas led the latest follow-ons with a $400m offering followed by TG Therapeutics with a $275m stock sale.
Keeping Track: Regeneron Ebola Antibody Cocktail Inmazeb Approved; Avenue Feels Pain From CRL; Scynexis Submits Oral Antifungal
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.
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.