US FDA closed out the month of April with two new molecular entity approvals that address underserved markets but carry some safety concerns.

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.

Scynexis sees a $300m-$400m commercial opportunity for the supplemental indication. A new therapeutic option is needed for oral step-down therapy because many Candida infections are resistant to oral fluconazole.

The first-in-class, novel antifungal for vaginal yeast infections will enter a genericized market, but also one with strong demand for better therapeutic options.