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Cytokinetics Reports Fourth Quarter 2024 Financial Results and Provides Business Update
CYTKCytokinetics(CYTK) GlobeNewswire·2025-02-27 21:00

Core Insights - Cytokinetics is preparing for the commercial launch of aficamten, a cardiac myosin inhibitor, with regulatory submissions under review in the U.S., Europe, and China, targeting a PDUFA date of September 26, 2025 [1][3][10] - The company reported significant progress in clinical trials and financial guidance for 2025, indicating a strong balance sheet with approximately 1.2billionincashandinvestmentsasofDecember31,2024[1][14][21]RegulatoryandClinicalDevelopments−TheFDAacceptedtheNewDrugApplication(NDA)foraficamten,whichisintendedforthetreatmentofobstructivehypertrophiccardiomyopathy(HCM),withastandardreviewprocessunderway[3][10]−TheEuropeanMedicinesAgency(EMA)validatedtheMarketingAuthorizationApplication(MAA)foraficamten,andtheChinaNationalMedicalProductsAdministration(NMPA)acceptedtheNDAforpriorityreview[3][10]−OngoingclinicaltrialsincludeMAPLE−HCM,ACACIA−HCM,andCEDAR−HCM,withtoplineresultsfromMAPLE−HCMexpectedinQ22025[3][9][10]FinancialPerformance−TotalrevenuesforQ42024were1.2 billion in cash and investments as of December 31, 2024 [1][14][21] Regulatory and Clinical Developments - The FDA accepted the New Drug Application (NDA) for aficamten, which is intended for the treatment of obstructive hypertrophic cardiomyopathy (HCM), with a standard review process underway [3][10] - The European Medicines Agency (EMA) validated the Marketing Authorization Application (MAA) for aficamten, and the China National Medical Products Administration (NMPA) accepted the NDA for priority review [3][10] - Ongoing clinical trials include MAPLE-HCM, ACACIA-HCM, and CEDAR-HCM, with topline results from MAPLE-HCM expected in Q2 2025 [3][9][10] Financial Performance - Total revenues for Q4 2024 were 16.9 million, a significant increase from 1.7millioninQ42023,drivenbya1.7 million in Q4 2023, driven by a 15 million upfront payment from Bayer for aficamten's development rights in Japan [15][20] - R&D expenses for Q4 2024 were 93.6 million, reflecting increased investment in clinical trials, while G&A expenses rose to 62.3 million due to commercial readiness efforts [18][19] - The net loss for Q4 2024 was 150million,or150 million, or (1.26) per share, compared to a net loss of 136.9million,or136.9 million, or (1.38) per share, in Q4 2023 [20][32] Strategic Initiatives - The company aims to advance its go-to-market strategies for aficamten in the U.S. and Europe, with plans to coordinate with Sanofi for potential approval in China [16][21] - Cytokinetics has outlined its Vision 2030 strategic objectives to enhance its position as a leading muscle-focused biopharmaceutical company [16][25] - The company is also developing additional drug candidates, including omecamtiv mecarbil and CK-586, targeting various heart failure conditions [25]