MAPLE-HCM trial results presented by Cytokinetics (NASDAQ: CYTK) at ESC 2025

Rhea-AI Filing Summary

Cytokinetics, Incorporated filed a report to highlight a key clinical milestone. The company announced that the primary results from its MAPLE-HCM study, which compares metoprolol with aficamten in patients with left ventricular outflow tract (LVOT) obstruction and hypertrophic cardiomyopathy (HCM), were presented in a Hot Line Session at the European Society of Cardiology Congress 2025 in Madrid, Spain. At the same time, these results were published in The New England Journal of Medicine, underscoring the scientific importance of the data. A full press release describing this announcement is included as Exhibit 99.1, giving more detail on the study and its findings.

Insights

Biotech and clinical trial specialist

Cytokinetics reports primary MAPLE-HCM results shared at a major cardiology meeting and in a top journal.

The disclosure centers on primary results from MAPLE-HCM, a study comparing metoprolol and aficamten in patients with hypertrophic cardiomyopathy and LVOT obstruction. These results were presented in a Hot Line Session at the European Society of Cardiology Congress 2025, a setting typically used for higher-profile cardiovascular trials, and were simultaneously published in The New England Journal of Medicine, which signals scientific relevance.

The filing itself does not describe whether outcomes favored either treatment or provide numerical efficacy or safety data, so the direction of impact on the business cannot be assessed from this text alone. The inclusion of a detailed press release as Exhibit 99.1 indicates that more granular trial information and context are available there, and future company communications and filings are likely to rely on those disclosed clinical results.

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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): August 30, 2025

Cytokinetics, Incorporated

(Exact name of Registrant as Specified in Its Charter)

Delaware			000-50633	94-3291317
(State or Other Jurisdiction of Incorporation)			(Commission File Number)	(IRS Employer Identification No.)
350 Oyster Point Boulevard
South San Francisco, California				94080
(Address of Principal Executive Offices)				(Zip Code)

Registrant’s Telephone Number, Including Area Code: (650) 624-3000

n/a

(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, $0.001 par value		CYTK		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.

Cytokinetics, Incorporated announced that the primary results of MAPLE-HCM (Metoprolol vs Aficamten in Patients with LVOT Obstruction on Exercise Capacity in HCM) were presented in a Hot Line Session at the European Society of Cardiology Congress 2025 in Madrid, Spain, and simultaneously published in The New England Journal of Medicine. The full text of the press release issued in connection with this announcement is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

Item 9.01 Financial Statements and Exhibits.

99.1 Press Release dated August 30, 2025

104 The cover page of this report has been 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.

			CYTOKINETICS, INCORPORATED
Date:	September 2, 2025	By:	/s/ John Faurescu
			SVP, Deputy General Counsel & Secretary

FAQ

What did Cytokinetics (CYTK) announce in this 8-K filing?

Cytokinetics announced that the primary results of its MAPLE-HCM trial were presented in a Hot Line Session at the European Society of Cardiology Congress 2025 and simultaneously published in The New England Journal of Medicine.

What is the MAPLE-HCM study mentioned by Cytokinetics (CYTK)?

MAPLE-HCM is a study titled “Metoprolol vs Aficamten in Patients with LVOT Obstruction on Exercise Capacity in HCM,” comparing metoprolol with aficamten in patients with hypertrophic cardiomyopathy and left ventricular outflow tract obstruction.

Where were the MAPLE-HCM primary results from Cytokinetics presented?

The primary results from MAPLE-HCM were presented in a Hot Line Session at the European Society of Cardiology Congress 2025 in Madrid, Spain.

Were the Cytokinetics MAPLE-HCM results published in a medical journal?

Yes. Cytokinetics stated that the primary MAPLE-HCM results were simultaneously published in The New England Journal of Medicine at the time of the congress presentation.

What is Exhibit 99.1 in Cytokinetics’ 8-K about MAPLE-HCM?

Exhibit 99.1 is a press release dated August 30, 2025, that provides the full text of Cytokinetics’ announcement regarding the MAPLE-HCM primary results and their presentation and publication.

Does this Cytokinetics (CYTK) 8-K include new financial statements?

No. The 8-K describes an “Other Events” item focused on the MAPLE-HCM clinical results and lists a related press release as an exhibit; it does not provide new financial statements.