Cytokinetics, Incorporated (CYTK) announced that the FDA has accepted the company’s new drug application (NDA) for lead pipeline candidate, aficamten.Aficamten is a next-in-class cardiac myosin inhibitor. The NDA is seeking approval of the candidate for the treatment of obstructive hypertrophic cardiomyopathy (HCM).Year to date, Cytokinetics’ shares have lost 39.5% compared with the industry’s 7% decline.Image Source: Zacks Investment ResearchCYTK’s NDA AcceptanceThe regulatory body assigned a standard revi ...

SOUTH SAN FRANCISCO, Calif., Dec. 03, 2024 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that COMET-HF (Confirmation of Omecamtiv Mecarbil Efficacy Trial in Heart Failure), a confirmatory Phase 3 clinical trial of omecamtiv mecarbil in patients with symptomatic heart failure (HF) with severely reduced ejection fraction, is open to enrollment. Omecamtiv mecarbil is a novel investigational selective cardiac myosin activator in development for the potential treatment of heart fa ...

SOUTH SAN FRANCISCO, Calif., Dec. 02, 2024 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that the Company is scheduled to participate in the following December investor conferences: 7th Annual Evercore ISI HealthconX Conference: Cytokinetics will participate in a fireside chat on Tuesday, December 3, 2024 at 9:35 AM Eastern Time at the Loews Coral Gables Hotel in Coral Gables, FL.36th Annual Piper Sandler Healthcare Conference: Cytokinetics will participate in a fireside chat ...

PDUFA Target Action Date Set for September 26, 2025 SOUTH SAN FRANCISCO, Calif., Dec. 02, 2024 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that the U.S. Food & Drug Administration (FDA) has accepted the company’s New Drug Application (NDA) for aficamten, a next-in-class cardiac myosin inhibitor, for the treatment of obstructive hypertrophic cardiomyopathy (HCM). The FDA assigned the NDA a standard review with a Prescription Drug User Fee Act (PDUFA) target action date of Se ...

Approximately €70 Million in Upfront and Near-term Payments to Cytokinetics Up to €490 Million in Commercial Milestone Payments, withTiered Royalties on Future Sales SOUTH SAN FRANCISCO, Calif. and BERLIN, Nov. 19, 2024 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) and Bayer today announced they have entered into a collaboration and license agreement for the exclusive development and commercialization of aficamten in Japan for the treatment of patients with obstructive and non-obstructive hy ...

Two New Analyses from SEQUOIA-HCM Demonstrate Treatment with Aficamten Improves Post-Exercise Oxygen Uptake Recovery and Quality of Life New Data from FOREST-HCM Demonstrate Aficamten Durably Reduces the Proportion of Patients Guideline Eligible for Septal Reduction Therapy Analyses of Real-World Data Reveal Cost of Care Differences in HCM Across Gender, Age and Race/Ethnicity SOUTH SAN FRANCISCO, Calif., Nov. 16, 2024 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced new data re ...

SOUTH SAN FRANCISCO, Calif., Nov. 16, 2024 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced new data from post-hoc analyses of GALACTIC-HF (Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure), the Phase 3 cardiovascular outcomes clinical trial of omecamtiv mecarbil were presented at the American Heart Association Scientific Sessions 2024 in Chicago, IL. “These analyses reinforce the potential treatment benefit of omecamtiv mecar ...

Advancement of Fast Skeletal Muscle Troponin Activator Expands Pipeline of Muscle-Directed Drug Candidates SOUTH SAN FRANCISCO, Calif., Nov. 11, 2024 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that the first participants have been dosed in a Phase 1 randomized, double-blind, placebo-controlled, multi-part, single and multiple ascending dose clinical study of CK-4015089 (CK-089) in healthy human participants. CK-089 is a fast skeletal muscle troponin activator (FSTA) with p ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to | --- | --- | --- | |-----------------------------------------------------------------------------------------------------------|---- ...

Financial Data and Key Metrics Changes - The company reported total revenues of $0.5 million for Q3 2024, an increase from $0.4 million in the same period of 2023 [48] - R&D expenses rose to $84.6 million in Q3 2024 from $82.5 million in Q3 2023, driven by higher personnel-related expenses [48] - G&A expenses increased to $56.7 million in Q3 2024 compared to $40.1 million in Q3 2023, primarily due to investments in commercial readiness [49] - The net loss for Q3 2024 was $160.5 million, or $1.36 per share, compared to a net loss of $129.4 million, or $1.35 per share, in Q3 2023 [50] - Cash, cash equivalents, and investments decreased to approximately $1.3 billion at the end of Q3 2024 from $1.4 billion at the end of Q2 2024 [47] Business Line Data and Key Metrics Changes - The company is advancing its clinical development programs, particularly for aficamten, with significant progress reported in the third quarter [6][10] - Aficamten's clinical data presented at various medical congresses showed improvements in exercise capacity, cardiac structure, and function [14][16] - The company is preparing to initiate two new clinical trials: COMET-HF for omecamtiv mecarbil and AMBER-HFpEF for CK-586 [11][39] Market Data and Key Metrics Changes - The company is executing pre-launch activities for aficamten, including a disease awareness campaign for healthcare professionals [27][28] - The commercial readiness activities in Europe are being prioritized, with plans to launch aficamten first in Germany [35] Company Strategy and Development Direction - The company aims to build momentum across its pipeline, focusing on multiple muscle-directed drug candidates to address diseases of high unmet need [13] - The strategic focus remains on specialty cardiology, with aficamten as a key product for obstructive HCM, followed by omecamtiv mecarbil and CK-586 [56] - The company is committed to prudent capital deployment to realize the full potential of its muscle biology platform [13][51] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming milestones for aficamten, including the expected launch in the U.S. in 2025, pending FDA approval [59] - The company is well-funded and positioned for future successes, with a focus on expanding its specialty cardiology franchise [55][56] Other Important Information - The company has strengthened its executive leadership team with the addition of a new Chief Legal Officer [54] - The company is preparing for potential global launches of aficamten, with a submission planned for the EMA in Q4 2024 [59] Q&A Session Summary Question: What is the confidence level in the MAPLE-HCM trial results? - Management believes the MAPLE-HCM trial will play an important role in the adoption of aficamten, with a conservative power analysis for the trial [68][70] Question: What is the expected timeline for guideline updates based on MAPLE results? - Management indicated that guidelines are updated regularly, and they aim to publish results quickly to influence treatment guidelines [76][78] Question: How does the company view the competitive position of omecamtiv mecarbil? - Management believes omecamtiv mecarbil fills an unmet need in the heart failure market, particularly for patients with severely reduced ejection fraction [112]