Scynexis Will Use Contract Commercial Firm To Market Novel Antifungal
Scynexis obtained US FDA approval of ibrexafungerp, from the first novel class of antifungals in 20 years, and plans to use a contractor for US marketing of Brexafemme for vaginal yeast infections caused by Candida fungi.
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Working with US FDA was key to developing clinical trials in the absence of regulatory precedents in recurrent vulvovaginal candidiasis, Scynexis VP tells the Pink Sheet; exposure profiles drove different trial designs for Scynexis’ Brexafemme and Mycovia’s just-launched Vivjoa.
Public Company Edition: Blackstone Life Sciences Yield will finance approved products, while the firm’s prior fund supports late-stage programs. Also, Coeptis will merge with a SPAC, Bausch + Lomb secured post-IPO debt, and BioXcel revealed a $260m financing and new subsidiary.
Phase III data showed that the first-in-class oral antifungal can prevent recurrence of vaginal yeast infections, a potentially valuable label addition to the current indication for acute treatment.