Company receives further regulatory clarity from FDA on Phase 3 ENABLAR-2 study. Potential for enobosarm +/- abemaciclib accelerated approval pathway in metastatic breast cancer, if successful based. -Today at 06:31 am- MarketScreener
11.05.2023 - Agreement reached with FDA on confirmatory Phase 3 clinical trial design for sabizabulin treatment of hospitalized COVID-19 adult patients at high risk for acute respiratory distress syndrome (ARDS), including two planned interim efficacy analyses .
Sabizabulin for moderate to severe COVID-19 under review for potential emergency authorization by multiple global regulatory agencies Presented late-breaker oral presentation at IDWeek; sabizabulin treatment