BREXAFEMME (ibrexafungerp tablets)
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SCYNEXIS Announces First Participants Dosed in a Phase 1 Single Ascending Dose and Multiple Ascending Dose Trial of Intravenous SCY-247
Globenewswire· 2026-02-26 13:23
Results from IV Phase 1 SAD/MAD Trial Expected in 2026JERSEY CITY, N.J., Feb. 26, 2026 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, today announced that the first participants have been dosed in a Phase 1 single ascending dose (SAD) and multiple ascending dose (MAD) trial evaluating the intravenous formulation (IV) of its second-generation triterpenoid antifungal therapy, S ...
SCYNEXIS and GSK Resolve Their Disagreement Related to the Restart of the Phase 3 MARIO Study
Globenewswire· 2025-10-15 12:00
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]