Core Insights - SCYNEXIS has successfully transferred the New Drug Application (NDA) for BREXAFEMME to GSK, enabling GSK to initiate regulatory discussions with the FDA for the relaunch of the drug targeting vulvovaginal candidiasis (VVC) and refractory vulvovaginal candidiasis (rVVC) in the U.S. market [1][2] - Following the relaunch, SCYNEXIS is set to receive up to $145.5 million in annual net sales milestones and royalties in the low to mid single-digit range, providing a significant source of non-dilutive capital for the company [1][2] Company Overview - SCYNEXIS, Inc. is a biotechnology company focused on developing innovative medicines to combat difficult-to-treat and drug-resistant infections, with a proprietary antifungal platform known as "fungerps" [3] - Ibrexafungerp, the first drug from this novel class, has been approved by the FDA for the treatment of VVC and for reducing the incidence of recurrent VVC [3] - The company is also advancing additional antifungal assets, including the compound SCY-247, which are in various stages of clinical and pre-clinical development [3]
SCYNEXIS Completes Transfer of BREXAFEMME® New Drug Application to GSK