Core Insights - SCYNEXIS, Inc. announced a $22 million payment from GlaxoSmithKline (GSK) as part of resolving a disagreement regarding the Phase 3 MARIO study on invasive candidiasis [1][6] - The company will not receive additional milestone payments from GSK related to the MARIO study and will begin wind-down activities [1][6] - GSK remains committed to collaborating with SCYNEXIS on the commercialization of BREXAFEMME for vulvovaginal candidiasis (VVC) and refractory vulvovaginal candidiasis (rVVC) [2][6] Financial Implications - The $22 million payment, along with existing cash and the removal of future MARIO expenditures, extends SCYNEXIS's cash runway to over two years [6] - An additional payment of $2.3 million will be received by SCYNEXIS for the wind-down activities associated with the MARIO study [1] Product Development - SCYNEXIS is progressing the transfer of the BREXAFEMME New Drug Application (NDA) to GSK, expected to be completed by the end of 2025 [2] - GSK plans to initiate regulatory interactions with the U.S. FDA in 2026 to discuss the relaunch of BREXAFEMME for VVC and rVVC [2] - The company continues to develop SCY-247, a second-generation antifungal aimed at treating and preventing invasive fungal infections [3][4]
SCYNEXIS and GSK Resolve Their Disagreement Related to the Restart of the Phase 3 MARIO Study