SCYX - SCYNEXIS gains after favorable data for antifungal agent in new indication

• SCYNEXIS ( NASDAQ: SCYX ) added ~8% in the morning hours Tuesday after the commercial-stage pharma company announced promising Phase 3 data for its oral antifungal medication ibrexafungerp in patients with recurrent vulvovaginal candidiasis (RVVC).
• According to the data from the 24-patient CANDLE sub-study, ibrexafungerp, an FDA-authorized therapy for vulvovaginal candidiasis, has led to clinical benefits in RVVC patients who failed to respond to another antifungal therapy called fluconazole.
• After one-day of ibrexafungerp (300 mg BID) treatment, 71% of RVVC patients (17 of 24) were found to have a significant reduction or elimination of signs and symptoms.
• Additionally, these results were replicated in a subset of patients who also demonstrated positive fungal cultures post-fluconazole treatment. In this 10-patient subgroup, 80% were found to have a favorable clinical response after one-day ibrexafungerp therapy.
• In June, SCYNEXIS ( SCYX ) announced the submission of its marketing application for label expansion of ibrexafungerp in the prevention of RVVC. The supplemental New Drug Application was backed by data from the pivotal Phase 3 CANDLE which indicated 65% clinical success for the treatment compared to ~53% for the placebo.

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