Relay Therapeutics, Inc. 8-K

What Happened
On February 3, 2026, Relay Therapeutics, Inc. announced via press release (filed on Form 8-K) that the U.S. Food and Drug Administration granted Breakthrough Therapy designation to zovegalisib (RLY-2608). The designation applies to zovegalisib in combination with fulvestrant for adults with PIK3CA‑mutant, hormone receptor‑positive, HER2‑negative (HR+/HER2-) locally advanced or metastatic breast cancer following recurrence or progression on or after treatment with a CDK4/6 inhibitor.

Key Details

• Date filed: February 3, 2026 (Current Report on Form 8-K; Exhibit 99.1 press release).
• Drug: zovegalisib (RLY-2608) in combination with fulvestrant.
• Indication: Adults with PIK3CA‑mutant HR+/HER2- locally advanced/metastatic breast cancer after recurrence/progression on/after a CDK4/6 inhibitor.
• Items reported on the 8-K: Item 7.01 (Regulation FD Disclosure) and Item 8.01 (Other Events). The filing includes the press release as Exhibit 99.1.

Why It Matters
Breakthrough Therapy designation is a regulatory recognition intended to expedite development and review for therapies addressing serious conditions with preliminary clinical evidence of substantial improvement over available therapies. For investors, this designation highlights regulatory progress for Relay’s lead oncology program and may accelerate interactions with the FDA and development timelines for the zovegalisib + fulvestrant regimen. The announcement does not itself report clinical or commercial milestones, financial results, or a guaranteed approval — it signals an elevated regulatory pathway for the program.