Shots:

• The P-III (CANDLE) study evaluates ibrexafungerp (300mg, bid) vs PBO in 260 patients with rVVC. The results will submit to the US FDA in H1’22 with an expected approval at the end of 2022
• The results showed that patients achieved clinical success with no recurrence in culture-proven, presumed, or suspected (65.4% vs 53.1%) @24wks., benefits were sustained over 3mos. follow-up period & remained significant while 2EPs were consistent with the results of primary analysis
• Additionally, 71% reduction or elimination of signs & symptoms who failed to respond to a three-day regimen of fluconazole., was safe & well-tolerated with no SAEs & no discontinuation due to AEs

Ref: GlobeNewswire | Image: GlobeNewswire