NasdaqGM:RLAYBiotechs
FDA Breakthrough Status For Zovegalisib Combo Might Change The Case For Investing In Relay Therapeutics (RLAY)
Relay Therapeutics recently announced that the U.S. FDA granted Breakthrough Therapy designation to its PI3Kα inhibitor zovegalisib (RLY-2608) in combination with fulvestrant for adults with PIK3CA‑mutant HR+/HER2‑ locally advanced or metastatic breast cancer after CDK4/6 inhibitor treatment, supported by Phase 1/2 ReDiscover trial data and an ongoing Phase 3 study.
This regulatory milestone not only accelerates FDA feedback and review timelines but also highlights zovegalisib’s potential...