Brookline Capital Markets launched coverage of SCYNEXIS (NASDAQ:SCYX) with a “buy” rating and $5 price target. The stock closed at $1.07 on Aug. 19.
Analyst Kumaraguru Raja writes that SCYNEXIS’ lead product candidate, ibrexafungerp, has shown favorable clinical outcomes and has a good potential for treatment for broad spectrum of fungal infections, especially the resistant and difficult-to-treat ones. “This can become an important tool for managing infections from a broad range of fungal pathogens, including multiple drug resistant strains,” he added.
Apart from the good infection resolution demonstrated in refractory infections, Mr. Raja said the oral availability is a major advantage, which can help in avoiding fungal infections that are contracted from instruments like catheters, while still allowing for long-term therapy in outpatient settings.
In a Phase 2 trial, an oral dose of ibrexafungerp of 300 mg twice daily led to a clinical cure in 52% of patients, compared with 58% for fluconazole, at day 10, and 70% vs. 50% at day 25.
The pivotal Phase 3 VANISH program, with two randomized double-blind studies, with 300 mg twice daily of ibrexafungerp, compared with placebo, in patients with acute vulvovaginal candidiasis, is expected to report in the first half of 2020, with the potential for an NDA in the second half of 2020.
The pivotal Phase 3 CANDLE study is planned to initiate soon to evaluate oral ibrexafungerp in recurrent vulvovaginal candidiasis. It has a special protocol assessment from the FDA.
