SEC Form 8-K filed by Cytokinetics Incorporated
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SECURITIES AND EXCHANGE COMMISSION
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Item 8.01 Other Events.
Regulatory Updates
On September 15, 2025, Cytokinetics, Incorporated (the “Company”) participated in a Late Cycle Meeting with the United States Food and Drug Administration (“FDA”) in connection with the Company’s New Drug Application (“NDA”) for aficamten in obstructive hypertrophic cardiomyopathy (“oHCM”). In that meeting, the Company discussed its proposed REMS program, including Elements to Assure Safe Use (“ETASU”) and anticipated post-marketing requirements with respect to aficamten. Prior to the Late Cycle Meeting, the Company received FDA’s response to the Company’s proposed REMS and label for aficamten. Based on the Company’s discussions and communications with FDA to date, the Company continues to expect a differentiated label and risk mitigation profile for aficamten, if approved by the FDA. As previously announced, the Company completed all Good Clinical Practice (“GCP”) inspections for aficamten and received communications from FDA that no observations were noted. There have been no Good Manufacturing Practice (“GMP”) inspections for aficamten scheduled. The Prescription Drug User Fee Act (“PDUFA”) target action date for the NDA for aficamten remains December 26, 2025. In addition, the Company recently submitted responses to Day 120 List of Questions from the Committee for Medicinal Products for Human Use (“CHMP”) from European Medicines Agency (“EMA”) with respect to the potential approval of aficamten in the European Union.
Royalty Pharma Development Funding Loan Agreement
As previously disclosed, the Company is entitled to draw up to $100.0 million of Tranche 5 term loans at any time prior to November 25, 2025 under the Development Funding Loan Agreement (the “Loan Agreement”) with Royalty Pharma Development Funding, LLC and the other parties thereto. The Company intends to draw the full $100.0 million of the Tranche 5 term loans on or about October 1, 2025.
Forward-Looking Statements
This Current Report on Form 8-K includes forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934, as amended, including statements regarding: receipt of regulatory approval by FDA, EMA or any other regulatory authority to enable our commercialization of aficamten in the United States or any other jurisdiction by the target PDUFA date or any other date, if ever, the Company’s expectation that aficamten will be approved with a differentiated label and risk mitigation profile and the timing and amount of funds drawn under the Loan Agreement. Forward-looking statements represent the Company’s current expectations regarding future events and are subject to known and unknown risks and uncertainties that could cause actual results to differ materially from those implied by the forward-looking statements. Among those risks and uncertainties are risks related to FDA’s on-going review of our NDA for aficamten in oHCM, including the timing of any approval (if ever), the final labeling, terms of any REMs program or other limitations or obligations imposed by FDA or foreign regulatory authorities, the impact of any such limitations or obligations on commercial success of aficamten, the Company’s ability to draw down funds under the Loan Agreement and comply with the terms and conditions of such Loan Agreement, and such other risks and uncertainties described under the caption “Risk Factors” and elsewhere in the Company’s filings with the SEC, including in its Quarterly Report on Form 10-Q for the period ended June 30, 2025, filed with the SEC on August 7, 2025, and the future quarterly and current reports that the Company files with the SEC. The forward-looking statements included in this Current Report on Form 8-K speak only as of the date of this Current Report on Form 8-K, and the Company does not undertake to update the statements included in this Current Report on Form 8-K for subsequent developments, except as may be required by law.
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the Company has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| CYTOKINETICS, INCORPORATED | ||||||
| Date: September 16, 2025 | By: | /s/ Sung Lee | ||||
| Sung H. Lee | ||||||
| Executive Vice President, Chief Financial Officer | ||||||