400mg BID fed is the dose used in the ongoing Phase 3 ReDiscover-2 trial, which initiated mid-2025 11.1-month median PFS in heavily pre-treated patients with PI3Kα-mutated, HR+/HER2- metastatic breast cancer Efficacy in patients with kinase and non-kinase domain mutations is similar, with median PFS of 11.2 and 11.0 months, respectively Safety and tolerability data are consistent with 600mg BID fasted data Zovegalisib has received FDA Breakthrough Therapy designation for the Phase 3 ReDiscover-2 trial popu ...