Zovegalisib is a clinical-stage precision oncology candidate from Relay Therapeutics being studied in combination regimens for PI3Kα-mutated HR+/HER2- advanced or metastatic breast cancer. The program has advanced into a global Phase 3 trial and received FDA Breakthrough Therapy designation in the pivotal trial population. It remains investigational.
Relay Therapeutics reported full-year 2025 revenue of $15.36 million and a narrowed net loss of $276.48 million, while securing FDA Breakthrough Therapy designation for lead asset zovegalisib. The company filed a $96.18 million shelf registration.
MoonLake Immunotherapeutics says FDA feedback indicates sufficient data to support a U.S. BLA for hidradenitis suppurativa without additional efficacy trials, while Relay Therapeutics received FDA Breakthrough Therapy designation for zovegalisib in combination with fulvestrant for PIK3CA-mutant breast cancer.
