Cytokinetics Files 8-K

TL;DR

Cytokinetics filed a routine 8-K, no major news yet.

AI Summary

Cytokinetics, Inc. filed an 8-K on May 8, 2024, reporting an "Other Event." The filing does not contain specific details about the event itself, but it confirms the company's reporting obligations under the Securities Exchange Act of 1934. The company is incorporated in Delaware and headquartered in South San Francisco, California.

Why It Matters

This filing indicates that Cytokinetics, Inc. is fulfilling its regulatory reporting requirements with the SEC, which is standard practice for publicly traded companies.

Risk Assessment

Risk Level: low — This is a standard regulatory filing with no new material information disclosed.

Key Numbers

• 000-50633 — Commission File Number (Identifies the company's SEC filing history)
• 94-3291317 — IRS Employer Identification No. (Company's tax identification number)

Key Players & Entities

• Cytokinetics, Inc. (company) — Registrant
• May 08, 2024 (date) — Date of earliest event reported
• 350 Oyster Point Boulevard (location) — Principal Executive Offices
• South San Francisco, California (location) — Principal Executive Offices
• 94080 (location) — Zip Code

FAQ

Key Financial Figures

• $0.001 — nge on which registered Common Stock, $0.001 par value CYTK The Nasdaq Global Se

Filing Documents

• cytk-20240508.htm (8-K) — 45KB
• 0000950170-24-055054.txt ( ) — 158KB
• cytk-20240508.xsd (EX-101.SCH) — 24KB
• cytk-20240508_htm.xml (XML) — 5KB

01 Other Events

Item 8.01 Other Events. On May 8, 2024, Cytokinetics, Incorporated (the "Company") announced that CEDAR-HCM ( C linical E valuation of D osing with A ficamten to R educe Obstruction in a Pediatric Population in HCM) , a clinical trial of aficamten in a pediatric population with symptomatic obstructive hypertrophic cardiomyopathy (HCM), is open to enrollment. Aficamten is a next-in-class cardiac myosin inhibitor in development for the potential treatment of HCM. CEDAR-HCM: Clinical Trial Design CEDAR-HCM is a multi-center, randomized, double-blind, placebo-controlled and open-label extension clinical trial to evaluate the efficacy, pharmacokinetics (PK) and safety of aficamten in a pediatric population with symptomatic obstructive HCM. The primary endpoint is the change in Valsalva left ventricular outflow tract gradient (LVOT-G) from baseline to Week 12. Secondary endpoints include the change from baseline to Week 12 in resting LVOT-G, New York Heart Association (NYHA) Functional Class, pharmacokinetics and cardiac biomarkers including NT-proBNP and hs-cTnI. CEDAR-HCM is expected to enroll two cohorts, beginning with an initial cohort of approximately 40 adolescent patients aged 12 to 17. Adolescent patients enrolled in CEDAR-HCM must have LVEF 60%, Valsalva LVOT-G 50 mmHg and NYHA Functional Class II. Patients will be randomized on a 2:1 basis to receive aficamten or placebo, and those receiving aficamten will begin with 5 mg dosed once daily. At weeks 2, 4 and 6 patients will receive an echocardiogram to determine if they will be up-titrated to escalating doses of 10, 15 or 20 mg. Dose escalation will occur only if a patient has a Valsalva LVOT-G 30 mmHg and an LVEF 55%. Safety, efficacy and PK data obtained from at least 20 adolescent patients who have completed 12 weeks of double-blind treatment will support the decision to open enrollment in a second cohort of approximately 8 to 10 younger patients (aged 6 to 11). The protocol will be amended to include

Forward-Looking Statements

Forward-Looking Statements This filing 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 express or implied relating to the properties or potential benefits of aficamten or any of our other drug candidates and our ability to fully enroll CEDAR-HCM. Such statements are based on management's current expectations, but actual results may differ materially due to various risks and uncertainties, including, but not limited to the risks related to Cytokinetics' business outlines in Cytokinetics' filings with the Securities and Exchange Commission. Forward-looking statements are not guarantees of future performance, and Cytokinetics' actual results of operations, financial condition and liquidity, and the development of the industry in which it operates, may differ materially from the forward-looking statements contained in this press release. Any forward-looking statements that Cytokinetics makes in this press release speak only as of the date of this press release. 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.

SIGNATURES

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: May 8, 2024 By: /s/ John O. Faurescu John O. Faurescu, Esq., Associate General Counsel & Secretary

View Full Filing

View this 8-K filing on SEC EDGAR