Biomea Fusion sets BMF-650 Phase I data for Oct 2026

Biomea Fusion, Inc. (BMEA) reports an update to the anticipated timing of topline results from its ongoing Phase I GLP-131 trial of BMF-650 in obese, otherwise healthy volunteers.

Available on EDGAR 09/22/2026 - 04:02 PM EDT Accepted by SEC EDGAR 09/22/2026 - 04:01 PM EDT Learn about SEC filing dates

Rhea-AI Filing Summary

Biomea Fusion, Inc. (BMEA) reports an update to the anticipated timing of topline results from its ongoing Phase I GLP-131 trial of BMF-650 in obese, otherwise healthy volunteers. The topline data are now expected in October 2026, adjusting the company’s prior expectations for when initial results will be available.

8-K Event Classification

Item 8.01 — Other Events

1 item

Item 8.01 Other Events Other

Voluntary disclosure of events the company deems important to shareholders but not covered by other items.

Key Figures

Updated topline data timing: October 2026 Update date: September 22, 2026

2 metrics

Updated topline data timing October 2026 Expected timing for topline results from the Phase I GLP-131 trial of BMF-650

Update date September 22, 2026 Date Biomea Fusion updated the anticipated timing for topline trial results

Key Terms

topline results, Phase I, obese, otherwise healthy volunteers

3 terms

topline results medical

"updated the anticipated timing for topline results from the Company’s ongoing Phase I"

Topline results are the initial, high-level summary of the most important outcomes from an event such as a clinical trial or a company reporting period — for a drug study this means whether the main goals were met and basic safety info, and for a company it often means headline revenue and profit figures. Investors care because these summaries act like a headline that quickly signals whether prospects have improved or worsened, often driving immediate market reactions before the full details are released.

Phase I medical

"from the Company’s ongoing Phase I GLP-131 trial for BMF-650 in obese"

A Phase I clinical trial is the first stage of testing a new drug or treatment in humans, focused mainly on safety and finding an appropriate dose by studying a small group of volunteers or patients. Investors watch Phase I results because they reveal early signs of safety, tolerability and how the body handles the treatment—information that helps gauge development risk and the likelihood and timing of later, larger trials that drive a drug’s value, much like a test drive reveals whether a prototype is worth further investment.

obese, otherwise healthy volunteers medical

"GLP-131 trial for BMF-650 in obese, otherwise healthy volunteers, which are now"

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Biomea Fusion (BMEA) announce about the BMF-650 GLP-131 trial timing?

Biomea Fusion announced that topline results from its ongoing Phase I GLP-131 trial of BMF-650 in obese, otherwise healthy volunteers are now expected in October 2026, updating the previously anticipated timing for when these initial data will be available.

What stage is Biomea Fusion’s (BMEA) BMF-650 GLP-131 study in?

The BMF-650 GLP-131 study described by Biomea Fusion is in Phase I, evaluating the drug candidate in obese, otherwise healthy volunteers as part of its early-stage clinical development.

Which patient population is enrolled in Biomea Fusion’s (BMEA) GLP-131 BMF-650 trial?

The GLP-131 trial for BMF-650 is being conducted in obese, otherwise healthy volunteers, indicating participants have obesity but no other significant health issues as specified in the disclosure.

When did Biomea Fusion (BMEA) update the timing for BMF-650 topline results?

Biomea Fusion updated the anticipated timing for BMF-650 topline results on September 22, 2026, stating that topline Phase I GLP-131 trial data are now expected in October 2026.

Does Biomea Fusion’s (BMEA) disclosure mention any financial impact from the BMF-650 trial update?

No financial impact is described. The disclosure focuses on the timing update for topline results from the Phase I GLP-131 trial of BMF-650, now expected in October 2026, without stating related financial effects.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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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): September 22, 2026

Biomea Fusion, Inc.

(Exact name of registrant as specified in its charter)

Delaware			001-40335	82-2520134
(State or other jurisdiction of incorporation)			(Commission File Number)	(IRS Employer Identification No.)
1599 Industrial Road
San Carlos, California				94070
(Address of principal executive offices)				(Zip Code)

Registrant’s telephone number, including area code: 650 980-9099

Not Applicable

(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, $0.0001 par value		BMEA		The Nasdaq Global Select 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 8.01. Other Events.

On September 22, 2026, Biomea Fusion, Inc. (the “Company”) updated the anticipated timing for topline results from the Company’s ongoing Phase I GLP-131 trial for BMF-650 in obese, otherwise healthy volunteers, which are now expected in October 2026.

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 thereunto duly authorized.

			Biomea Fusion, Inc.
Date:	September 22, 2026	By:	/s/ Michael J.M. Hitchcock
			Michael J.M. Hitchcock Interim Chief Executive Officer, Director (Principal Executive Officer)

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