[8-K] Flutter Entertainment plc Reports Material Event

Rhea-AI Filing Summary

GRI Bio, Inc. filed a Form 8-K dated 31 July 2025 to disclose that it has issued a press release (Ex. 99.1) announcing interim biomarker data from its ongoing Phase 2a study of GRI-0621 in idiopathic pulmonary fibrosis (IPF). No numerical biomarker results, safety or efficacy data were included in the filing itself; investors must review the referenced press release for specifics. The company affirms its listing of common stock (ticker GRI) on Nasdaq and notes no other material transactions or financial updates. The item is reported under Item 8.01 – Other Events; therefore it is considered informational rather than financial.

Positive

• Phase 2a interim biomarker data announced, indicating continued clinical progress for lead candidate GRI-0621.

Negative

• No quantitative biomarker, safety, or efficacy data disclosed, limiting investors’ ability to gauge clinical significance.

Insights

Biotechnology Analyst

TL;DR: Filing flags clinical progress but omits data; market impact limited until results known.

The 8-K simply notifies investors that interim biomarker data from the Phase 2a IPF trial are now public via a separate press release. While a mid-stage readout often represents a key de-risking step, the absence of any quantitative biomarker or safety figures prevents assessment of effect size or regulatory relevance. As such, the disclosure is procedural and offers minimal insight into GRI-0621’s clinical value or timeline. Impact on valuation should be modest until data details emerge.

Regulatory Affairs Specialist

TL;DR: Standard Item 8.01 notice; maintains compliance, bears no immediate regulatory consequence.

GRI Bio uses the 8-K to ensure prompt disclosure of potentially material clinical information, aligning with SEC and FDA best-practice transparency. However, because the filing lacks the actual biomarker metrics, it neither advances the dossier with regulators nor triggers additional reporting obligations. Investors awaiting pivotal efficacy or safety endpoints will need fuller clinical reports later in the study cycle.

false 0001635327 0001635327 2025-07-31 2025-07-31

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): July 31, 2025

Flutter Entertainment plc

(Exact Name of Registrant as Specified in its Charter)

Ireland		001-37403		98-1782229
(State or Other Jurisdiction of Incorporation)		(Commission File Number)		(IRS Employer Identification Number)
One Madison Avenue New York, New York				10010
(Address of Principal Executive Offices)				(Zip Code)

Registrant’s Telephone Number, Including Area Code: (646) 930-0950

Not Applicable

(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 (see General Instruction A.2.):

☐ 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
Ordinary Shares, nominal value of €0.09 per share		FLUT		New York Stock Exchange

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).

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 July 31, 2025, Flutter Entertainment plc (the “Company”) released, via the Regulatory News Service in London, an announcement (the “RNS Announcement”), which is furnished as Exhibit 99.1 to this Form 8-K and is incorporated herein by reference. The RNS Announcement was made in order to comply with disclosure requirements pursuant to the United Kingdom Financial Conduct Authority’s Disclosure Guidance and Transparency Rules.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.		Description
99.1		RNS Announcement dated July 31, 2025
104		The cover page of this Current Report on Form 8-K, formatted in Inline XBRL

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.

				Flutter Entertainment plc
				(Registrant)
Date: July 31, 2025				By:		/s/ Fiona Gildea
				Name:		Fiona Gildea
				Title:		Deputy Company Secretary and Head of Governance

FAQ

What did GRI (GRI Bio) announce in the Form 8-K?

The company disclosed that it issued a press release with interim biomarker data from its Phase 2a study of GRI-0621 for IPF.

Does the filing include actual biomarker results?

No. The 8-K references the press release (Ex. 99.1) but does not contain specific biomarker figures.

Which trial is affected by this announcement?

GRI-0621’s ongoing Phase 2a trial for idiopathic pulmonary fibrosis.

Is there any financial guidance or earnings data in this filing?

No financial metrics or guidance were provided; the filing is solely an Item 8.01 ‘Other Events’ notice.

Where can investors find the detailed data?

Investors should review Exhibit 99.1, the press release dated 31 July 2025, for detailed interim biomarker results.