Cytokinetics (NASDAQ: CYTK) gains CHMP backing for MYQORZO in EU HCM patients

Rhea-AI Filing Summary

Cytokinetics, Incorporated reported that the European Medicines Agency’s Committee for Medicinal Products for Human Use adopted a positive opinion recommending marketing authorization in the European Union for MYQORZO® (aficamten). The medicine is a cardiac myosin inhibitor intended to treat symptomatic New York Heart Association (NYHA) class II–III obstructive hypertrophic cardiomyopathy in adult patients.

The company stated that a final decision from the European Commission on this marketing application is anticipated in the first quarter of 2026. It also highlighted that statements about potential approval are forward-looking and that actual outcomes may differ from these expectations.

Positive

• CHMP issued a positive opinion recommending EU marketing authorization for MYQORZO® (aficamten) to treat symptomatic NYHA class II–III obstructive hypertrophic cardiomyopathy in adult patients, with a final European Commission decision anticipated in the first quarter of 2026.

Negative

• None.

Insights

Biotech regulatory analyst

CHMP’s positive opinion on MYQORZO marks a favorable EU regulatory step for Cytokinetics.

Cytokinetics disclosed that the EMA Committee for Medicinal Products for Human Use adopted a positive opinion recommending EU marketing authorization for MYQORZO® (aficamten). The product is aimed at adult patients with symptomatic NYHA class II–III obstructive hypertrophic cardiomyopathy, which is a clearly defined patient group within cardiology.

The company also noted that a final decision from the European Commission is anticipated in the first quarter of 2026. Until that decision is made, MYQORZO is not yet authorized in the EU, and the outcome remains subject to regulatory review. The forward-looking statement language underscores that the eventual result may differ from current expectations.

If the European Commission grants marketing authorization, MYQORZO would be available in the EU for the specified obstructive hypertrophic cardiomyopathy population. For now, the key next milestone is the anticipated European Commission decision in Q1 2026, which will determine whether this positive opinion translates into actual approval.

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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): December 12, 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.

On December 12, 2025, Cytokinetics, Incorporated ("Cytokinetics" or the "Company") announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion recommending marketing authorization in the European Union for MYQORZO® (aficamten), a cardiac myosin inhibitor, for the treatment of symptomatic (New York Heart Association, NYHA, class II-III) obstructive hypertrophic cardiomyopathy in adult patients. A final decision is anticipated from the European Commission in the first quarter of 2026.

Forward Looking Statements

This Current Report on Form 8-K contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the “Act”). Cytokinetics disclaims any intent or obligation to update these forward-looking statements and claims the protection of the Act’s Safe Harbor for forward-looking statements. Examples of such statements include, but are not limited to, statements relating to the potential approval of MYQORZO® (aficamten) by the European Commission or any other instrumentality or regulatory agency as a treatment for obstructive hypertrophic cardiomyopathy or any other indication. Forward-looking statements are not guarantees of future performance, and actual results may differ materially from the forward-looking statements contained in this Current Report on Form 8-K. Any forward-looking statements that Cytokinetics makes in this Current Report on Form 8-K speak only as of the date of this report. Cytokinetics assumes no obligation to update its forward-looking statements whether as a result of new information, future events or otherwise, after the date of this report.

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:	December 12, 2025	By:	/s/ John O. Faurescu
			John O. Faurescu SVP, Deputy General Counsel & Secretary

FAQ

What did Cytokinetics (CYTK) announce about MYQORZO in Europe?

Cytokinetics announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use adopted a positive opinion recommending marketing authorization in the European Union for MYQORZO® (aficamten).

What condition is MYQORZO (aficamten) intended to treat?

MYQORZO® (aficamten) is intended to treat symptomatic New York Heart Association (NYHA) class II–III obstructive hypertrophic cardiomyopathy in adult patients.

Is MYQORZO already approved in the European Union?

No final decision has been made yet. Cytokinetics stated that a final European Commission decision on marketing authorization is anticipated in the first quarter of 2026.

When is the European Commission decision on MYQORZO expected?

The company expects the European Commission to issue a final decision on the MYQORZO® (aficamten) marketing application in the first quarter of 2026.

What forward-looking statement cautions did Cytokinetics include?

Cytokinetics noted that statements about the potential approval of MYQORZO® (aficamten) are forward-looking, are not guarantees of future performance, and that actual results may differ materially, with no obligation to update such statements after the date of the report.