Business
Cytokinetics Reports Second Quarter 2024 Financial Results
Type B Meeting Held with FDA Related to Potential Risk Mitigation Strategies for Aficamten;Company Has Initiated Rolling NDA Submission FDA Cleared Protocol
About this update from Cytokinetics, Incorporated
[{"type":"text","content":"Type B Meeting Held with FDA Related to Potential Risk Mitigation Strategies for Aficamten;Company Has Initiated Rolling NDA Submission FDA Cleared Protocol Amendment for FOREST-HCM Reducing Frequency ofEchocardiographic Monitoring Required During Maintenance Treatment ~$1.4 Billion in Cash, Cash Equivalents and Investments as of June 30, 2024 SOUTH SAN FRANCISCO, Calif., Aug. 08, 2024 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) reported a management update and financial results for the second quarter of 2024. “Cytokinetics made substantial progress during the second quarter across our pipeline and aligned to near-term goals as well as our longer-term vision to build a sustainable specialty cardiology business. In May, we secured contingent access to more than $1 billion in funding to support the potential global launch of aficamten as well as to continue conduct of label-expanding clinical trials of aficamten worldwide and to advance our later-stage pipeline including omecamtiv mecarbil and CK-586,” said Robert I. Blum, Cytokinetics’ President and Chief Executive Officer. “These three programs, anchored in our pioneering science of myosin modulation, provide synergistic opportunities in adjacent specialty cardiology indications that we believe will unlock shareholder value while making good on our promise to patients.” Q2 and Recent Highlights Cardiac Muscle Programs aficamten (cardiac myosin inhibitor) Presented primary results from SEQUOIA-HCM (Safety, Efficacy, and Quantitative Understanding of Obstruction Impact of Aficamten in HCM) at the European Society of Cardiology Heart Failure 2024 Congress, demonstrating statistically significant and clinically meaningful improvements in the primary efficacy endpoint of peak oxygen uptake (pVO2) and all secondary endpoints with results consistent across all prespecified subgroups. Additional results presented from SEQUOIA-HCM showed that treatment with aficamten resulted in predictable dosing with no dose interruptions or associated heart failure due to left ventricular ejection fraction (LVEF) 55%. Participated in meetings with the European Medicines Agency (EMA) and National Agencies in the EU during which the company confirmed plans to submit a Marketing Authorization Application (MAA) for aficamten in Q4 2024 and discussed the content of the expected filing. Co...