Cytokinetics Incorporated filed SEC Form 8-K: Regulation FD Disclosure
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Item 7.01 Regulation FD Disclosure.
At upcoming investor conferences, Cytokinetics, Incorporated (the “Company”) will be providing, and is hereby furnishing, a brief regulatory update regarding its new drug application for aficamten. During these investor conferences, representatives of the company will make statements consistent with the following:
1. Cytokinetics has completed its midcycle review with the Food and Drug Administration (“FDA”) with respect to the New Drug Application (“NDA”) for aficamten for the treatment of obstructive hypertrophic cardiomyopathy.
2. FDA has informed Cytokinetics that it does not plan to convene an advisory committee meeting to review the Company’s NDA for aficamten.
3. We expect the Late Cycle meeting with FDA to occur in June 2025.
We maintain our expectation for a differentiated label and risk mitigation profile for aficamten, if approved by FDA.
As previously stated, the Company does not plan to share detailed updates on its communications with the FDA.
This Form 8-K contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the “Act”). Examples of such forward looking statements include statements regarding FDA’s decision on whether to hold an Advisory Committee regarding our NDA for aficamten, the timing of further interactions with FDA, and the potential nature of the label or risk mitigation profile of aficamten, if approved. Cytokinetics claims the protection of the Act’s Safe Harbor for forward-looking statements. For further information regarding risks related to the company’s statements in this Form 8-K, investors should consult our filings with the Securities and Exchange Commission, particularly under the caption “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2024. 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 press release.
The information furnished under this Item 7.01 shall not be considered “filed” under the Securities Exchange Act of 1934, as amended, nor shall it be incorporated by reference into any future filing under the Securities Act of 1933, as amended, or under the Securities Exchange Act of 1934, as amended, unless the Registrant expressly sets forth in such future filing that such information is to be considered “filed” or incorporated by reference therein.
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.
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CYTOKINETICS, INCORPORATED |
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Date: |
March 10, 2025 |
By: |
/s/ John O. Faurescu |
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John O. Faurescu, Secretary |