Cytokinetics Files 8-K: Other Events Reported

TL;DR

Cytokinetics filed an 8-K for 'Other Events' on 4/5/24 - details TBD.

AI Summary

Cytokinetics, Incorporated filed an 8-K on April 5, 2024, to report other events. The filing does not contain specific details about the nature of these events, dollar amounts, or definitive dates beyond the filing date itself.

Why It Matters

This 8-K filing indicates that Cytokinetics has reported an event requiring public disclosure, though the specifics are not detailed in the provided text.

Risk Assessment

Risk Level: low — The filing is a standard 8-K for 'Other Events' and does not contain specific financial or operational disclosures that would immediately indicate high risk.

Key Players & Entities

• Cytokinetics, Incorporated (company) — Registrant
• 350 Oyster Point Boulevard (location) — Principal Executive Offices
• South San Francisco, California (location) — Principal Executive Offices
• April 05, 2024 (date) — Date of Report

FAQ

Key Financial Figures

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

Filing Documents

• cytk-20240405.htm (8-K) — 46KB
• 0000950170-24-042057.txt ( ) — 158KB
• cytk-20240405.xsd (EX-101.SCH) — 24KB
• cytk-20240405_htm.xml (XML) — 5KB

01 Other Events

Item 8.01 Other Events. On April 5, 2024, Cytokinetics, Incorporated (the "Company" or the "Registrant") announced additional 48-week data from FOREST-HCM ( F ollow-up, O pen-Label, R esearch E valuation of S ustained T reatment with Aficamten in HCM ), the open label extension clinical study of aficamten in patients with hypertrophic cardiomyopathy (HCM), at the 73 rd Annual American College of Cardiology (ACC) Scientific Session taking place from April 6, 2024 –April 8, 2024 in Atlanta, GA. FOREST-HCM enrolled 213 patients with obstructive HCM from May 28, 2021 through October 31, 2023. Previously presented data from 17 patients who had been enrolled through 48 weeks in FOREST-HCM showed that prolonged treatment with aficamten was associated with significant and sustained reductions in left ventricle outflow tract gradient (LVOT-G), and improvements in symptoms and cardiac biomarkers. The updated data set presented at ACC in Atlanta focuses on 46 patients from FOREST-HCM that had completed 48 weeks of follow-up at the time of the current interim analysis. At Week 48, 75% of these patients were receiving the 15 mg or 20 mg dose of aficamten . Treatment with aficamten for 48 weeks resulted in substantial and sustained reductions in average resting LVOT-G (mean change from baseline (SD) = -39.6 mmHg (34), p<0.0001) and Valsalva LVOT-G (mean change from baseline (SD) = -53.2 mmHg (38.6), p<0.0001). Statistically significant improvements in New York Heart Association (NYHA) Functional Class from baseline were observed, with 82.2% of patients improving by 1 NYHA class with no instances of worsening NYHA class. Additionally, there were significant improvements in NT-proBNP, a biomarker of cardiac wall stress, with an average decrease of 63% from baseline to week 48 (p<0.001). Treatment with aficamten also resulted in statistically significant improvements in measures of cardiac structure and function including decreases in maximum wall thickness (mean change from b

Forward-Looking Statements

Forward-Looking Statements This press release 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 obtain regulatory approval for aficamten for the treatment of obstructive hypertrophic cardiomyopathy or any other indication from FDA or any other regulatory body in the United States or abroad. 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: April 5, 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