SCYNEXIS, Inc. (SCYX) Resumes Phase III Dosing for Brexafemme After 19-Month FDA Hold

SCYNEXIS, Inc. (NASDAQ:SCYX) has officially restarted patient dosing in its Phase III MARIO trial for Brexafemme (ibrexafungerp) after the FDA lifted a nearly two-year clinical hold. The hold, initiated over concerns of beta-lactam contamination at the original manufacturing facility, was removed once new drug batches were produced at a separate location. With trial sites now reactivated, patient enrollment has resumed, reaching about 25% of its 220-participant goal.

A pharmacist technician sorting pills in a drug pharmacy.

The MARIO trial explores Brexafemme’s use as an oral follow-up treatment to IV echinocandins for invasive candidiasis, a life-threatening fungal infection. SCYNEXIS, Inc. (NASDAQ:SCYX) received a $10 million milestone payment from GSK after the first new patient was dosed, though disagreements over further payments and trial duties have sparked tension between the two partners.

Previously recalled in 2023 due to contamination risks, Brexafemme had FDA approval for treating VVC. While its commercial progress has faced setbacks, projected global revenue could reach $139 million by 2031 if development succeeds.

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