Hot Line Presentation of MAPLE-HCM to Elaborate on Positive Topline Results in Patients with Obstructive Hypertrophic Cardiomyopathy Late Breaking Clinical Science Session to Present Incidence and Impact of Atrial Fibrillation Across Three Clinical Trials of Aficamten in Obstructive Hypertrophic Cardiomyopathy SOUTH SAN FRANCISCO, Calif., July 10, 2025 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced five presentations related to aficamten at the European Society of Cardiology C ...

Cytokinetics (CYTK) Conference Call Summary Company Overview - **Company**: Cytokinetics (CYTK) - **Event**: 2025 Conference on May 21, 2025 - **Key Speakers**: CEO Robert and CFO Sung Key Industry and Company Insights Regulatory Updates on Aficamten - Cytokinetics has engaged in multiple discussions with the FDA regarding aficamten, particularly after the SEQUOIA HCM pivotal clinical study results [3][4] - The FDA accepted the NDA submission without a Risk Evaluation and Mitigation Strategy (REMS) initially, but later determined that a REMS is necessary [5][4] - The company believes that aficamten will have a differentiated risk mitigation profile despite the REMS requirement [5][6] Market Positioning and Competitive Landscape - The cardiac myosin inhibitors category, including aficamten and mavacamten, is expected to grow, with a significant portion of eligible patients currently untreated [10][11] - Mavacamten is projected to generate over $1 billion in sales for BMS this year, with a concentrated prescription base among about 600 physicians [10] - Cytokinetics aims to differentiate aficamten through its dosing regimen, drug-drug interaction (DDI) profile, and overall convenience [6][11] Clinical Evidence and Ongoing Studies - Positive results from the MAPLE HCM study comparing aficamten to metoprolol were announced, which could enhance the drug's positioning in the market [12][13] - Ongoing studies like MAPLE and Acacia are expected to provide further evidence supporting aficamten's efficacy and safety [13][30] - The Acacia study has been modified to harmonize endpoints across regulatory jurisdictions, with increased enrollment to enhance statistical power [27][28] Commercial Strategy - Cytokinetics has been preparing for aficamten's launch, focusing on market analytics, segmentation, and omnichannel planning [18][19] - The company plans to target both new patients and those switching from other therapies, with a tailored approach for physicians and payers [18][24] - The launch strategy will be informed by lessons learned from the mavacamten launch, with a focus on driving category penetration beyond centers of excellence [20][24] Financial Position - As of Q1, Cytokinetics reported $1.1 billion in cash and investments, with access to an additional $425 million from partner Royalty Pharma [40][41] - This financial strength positions the company well for the launch of aficamten and advancement of its pipeline [41] Future Outlook - The PDUFA date for aficamten is set for the end of 2025, with expectations for market entry in 2026 [18] - The company is optimistic about the potential for omecamtiv and CK-586, with ongoing studies expected to yield significant insights [31][39] Additional Important Points - The company emphasizes the importance of ongoing clinical evidence and studies to support aficamten's market uptake beyond regulatory approvals [12][13] - There is a growing patient population with non-obstructive hypertrophic cardiomyopathy (NHCM), which could enhance aficamten's commercial profile if the Acacia study is positive [30] - Cytokinetics is focused on creating a patient hub to enhance the patient experience and drive demand for aficamten [26]

Trial Demonstrates Superiority of Aficamten to Standard of Care Beta Blocker in Improving Peak Exercise Capacity in Patients with Obstructive Hypertrophic Cardiomyopathy SOUTH SAN FRANCISCO, Calif., May 13, 2025 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced positive topline results from MAPLE-HCM (Metoprolol vs Aficamten in Patients with LVOT Obstruction on Exercise Capacity in HCM), a Phase 3 clinical trial comparing aficamten as monotherapy to the standard of care beta bloc ...

Cytokinetics (CYTK) 2025 Conference May 07, 2025 10:00 AM ET Speaker0 So I'm excited to be joined next at the Citizens Life Science Conference by Cytokinetics. Cytokinetics is a special specialty cardiology company with a focus on muscle biology. Really exciting time for the company with, Aficampton, PDUFA date. It's just several months away now. Obviously, lots of discussion over the last week about the the PDUFA extension, so we'll jump into that. But Robert and team just welcome and maybe I'll just ask y ...