Relay Therapeutics Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to zovegalisib (RLY-2608) in combination with fulvestrant for the treatment of adults with PIK3CA mutant, hormone receptor positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) locally advanced or metastatic breast cancer following recurrence or progression after treatment with a CDK4/6 inhibitor. The designation is supported by clinical data from the Phase 1⁄2 ReDiscover trial and is intended to accelerate the development and review of therapies for serious conditions with potential for substantial improvement over existing treatments. Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Relay Therapeutics Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9647240-en) on February 03, 2026, and is solely responsible for the information contained therein. © Copyright 2026 - Public Technologies (PUBT)

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FDA Grants Breakthrough Therapy Designation to Relay Therapeutics' Zovegalisib for Advanced Breast Cancer