FDA grants Breakthrough Therapy status to Relay Therapeutics (NASDAQ: RLAY) drug RLY-2608

Rhea-AI Filing Summary

Relay Therapeutics, Inc. reported that the U.S. Food and Drug Administration has granted Breakthrough Therapy designation to its drug candidate zovegalisib (RLY-2608) in combination with fulvestrant. This designation covers adults with PIK3CA mutant HR+/HER2- locally advanced or metastatic breast cancer that has recurred or progressed after treatment with a CDK4/6 inhibitor.

Positive

• FDA Breakthrough Therapy designation: The U.S. Food and Drug Administration granted Breakthrough Therapy designation to zovegalisib (RLY-2608) plus fulvestrant for adults with PIK3CA mutant HR+/HER2- locally advanced or metastatic breast cancer after progression on a CDK4/6 inhibitor.

Negative

• None.

Insights

Biotech regulatory and oncology analyst

Relay gains FDA Breakthrough Therapy status for zovegalisib combo in breast cancer.

Relay Therapeutics announced that the U.S. Food and Drug Administration granted Breakthrough Therapy designation to zovegalisib (RLY-2608) when used with fulvestrant. The designation is for adults with PIK3CA mutant HR+/HER2- locally advanced or metastatic breast cancer after recurrence or progression on a CDK4/6 inhibitor.

This development focuses on a clearly defined patient group: hormone receptor–positive, HER2‑negative breast cancer with PIK3CA mutations that has worsened despite prior CDK4/6 inhibitor therapy. The combination of zovegalisib with fulvestrant is the regimen identified in the designation.

The 8-K indicates this status through an attached press release, recorded as Exhibit 99.1 dated February 3, 2026. Subsequent company communications and filings may detail clinical data, development plans, or any changes to this program based on the designation.

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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): February 03, 2026

RELAY THERAPEUTICS, INC.

(Exact name of Registrant as Specified in Its Charter)

Delaware			001-39385	47-3923475
(State or Other Jurisdiction of Incorporation)			(Commission File Number)	(IRS Employer Identification No.)
60 Hampshire Street
Cambridge, Massachusetts				02139
(Address of Principal Executive Offices)				(Zip Code)

Registrant’s Telephone Number, Including Area Code: (617) 370-8837

(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common Stock, par value $0.001 per share		RLAY		Nasdaq Global Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 7.01 Regulation FD Disclosure.

On February 3, 2026, Relay Therapeutics, Inc. (the "Company") issued a press release announcing the grant of Breakthrough Therapy designation for zovegalisib (RLY-2608), a copy of which is furnished herewith as Exhibit 99.1 to this Current Report on Form 8-K.

The information in this Item 7.01, including Exhibit 99.1 attached hereto, is intended to be furnished and shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934 (the "Exchange Act"), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.

Item 8.01 Other Events.

On February 3, 2026, the Company announced that the U.S. Food and Drug Administration 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 on or after treatment with a CDK4/6 inhibitor.

Item 9.01 Financial Statements and Exhibits.

99.1	Press Release issued by Relay Therapeutics, Inc. on February 3, 2026, furnished herewith.
104	Cover Page Interactive Data File (embedded within Inline XBRL document).

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

			Relay Therapeutics, Inc.
Date:	February 3, 2026	By:	/s/ Soo-Yeun Lim
			Soo-Yeun Lim General Counsel

FAQ

What did Relay Therapeutics (RLAY) announce in its latest 8-K filing?

Relay Therapeutics announced that the U.S. Food and Drug Administration granted Breakthrough Therapy designation to its drug candidate zovegalisib (RLY-2608) in combination with fulvestrant for a specific type of advanced breast cancer after prior CDK4/6 inhibitor treatment.

Which Relay Therapeutics drug received FDA Breakthrough Therapy designation?

The FDA granted Breakthrough Therapy designation to zovegalisib, also known as RLY-2608, from Relay Therapeutics. The designation covers its use in combination with fulvestrant for adults with PIK3CA mutant HR+/HER2- locally advanced or metastatic breast cancer that has progressed after CDK4/6 inhibitor therapy.

For which breast cancer patients is zovegalisib’s Breakthrough Therapy designation intended?

The designation applies to adults with PIK3CA mutant hormone receptor positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) locally advanced or metastatic breast cancer. These patients must have experienced recurrence or progression on or after treatment with a CDK4/6 inhibitor to fit the described population.

What treatment combination is covered in Relay Therapeutics’ FDA designation?

The Breakthrough Therapy designation covers zovegalisib (RLY-2608) used in combination with fulvestrant. This combination is intended for adults with PIK3CA mutant HR+/HER2- locally advanced or metastatic breast cancer that has recurred or progressed after therapy with a CDK4/6 inhibitor, according to the company’s disclosure.

When did Relay Therapeutics disclose the Breakthrough Therapy designation for zovegalisib?

Relay Therapeutics disclosed the Breakthrough Therapy designation on February 3, 2026. On that date, the company reported that the U.S. Food and Drug Administration granted the status to zovegalisib (RLY-2608) plus fulvestrant and furnished a related press release as Exhibit 99.1.

Which exhibit in the Relay Therapeutics 8-K contains details on the designation?

Details are included in Exhibit 99.1, identified as a press release issued by Relay Therapeutics on February 3, 2026. The company states that this exhibit is furnished, not filed, under the Exchange Act, and it accompanies the 8-K as the primary communication of the announcement.