Key Takeaways Cytokinetics' aficamten beat metoprolol on all key efficacy measures in phase III MAPLE-HCM study.Aficamten improved exercise capacity, symptoms, and LVOT gradients in patients with obstructive HCM.FDA review of aficamten is underway with a target decision date now set for Dec. 26, 2025.Cytokinetics, Incorporated's ((CYTK) shares surged 40.4% on Sept. 2, driven by positive results from a phase III study on cardiovascular candidate aficamten.On Aug. 30, Cytokinetics presented primary results fr ...

Cytokinetics (CYTK) Update / Briefing September 02, 2025 08:30 AM ET Company ParticipantsDiane Weiser - SVP - Corporate AffairsFady Malik - EVP - R&DPablo Garcia-Pavia - CardiologistCarolyn Ho - Medical Director - Cardiovascular Genetics CenterAhmad Masri - Head - Cardiomyopathy SectionDaniel Jacoby - VP - Clinical ResearchAnjali Owens - Cardiovascular FellowRobert I. Blum - CEO, President & DirectorDiane WeiserWelcome, everyone, and thanks for joining. I'm Diane Weiser, SVP, corporate affairs. We're please ...

Cytokinetics (CYTK) Update Summary Company Overview - **Company**: Cytokinetics (CYTK) - **Focus**: Development of aficamtan for the treatment of obstructive hypertrophic cardiomyopathy (OHCM) Key Industry Insights - **Industry**: Cardiovascular Medicine - **Event**: European Society of Cardiology (ESC) Conference Core Findings from the Call 1. **Presentation of Data**: Cytokinetics presented four oral presentations and one poster on aficamtan, with three publications in leading cardiac journals, emphasizing its potential as a treatment for OHCM [7][8][27] 2. **MAPLE HCM Study**: The Phase III trial compared aficamtan to metoprolol, showing aficamtan's superiority in improving exercise capacity and reducing symptoms [8][26] 3. **Efficacy Results**: - Aficamtan showed a mean increase in peak VO2 of 1.1 mL/kg/min, while metoprolol showed a mean decrease of 1.2 mL/kg/min, with a statistically significant difference of 2.3 mL/kg/min (p < 0.001) [21][26] - Aficamtan improved NT proBNP levels by 81% compared to baseline, while metoprolol's levels increased [24][26] 4. **Safety Profile**: Aficamtan was well tolerated with a low incidence of adverse events, contrasting with metoprolol, which had a higher rate of dose reductions due to side effects [25][26] 5. **Long-term Data**: Data from FORWEST HCM indicated sustained hemodynamic benefits and low incidence of new onset atrial fibrillation over a mean follow-up of 62 weeks [11][12] Implications for Treatment 1. **Shift in Treatment Paradigm**: The results challenge the long-standing use of beta blockers as first-line therapy for symptomatic obstructive HCM, suggesting aficamtan as a more effective alternative [8][31] 2. **Guideline Updates**: Anticipation of updates to clinical guidelines to incorporate findings from MAPLE HCM and other studies, with a focus on aficamtan as a first-line therapy [77][79] Additional Insights 1. **Expert Perspectives**: Panelists highlighted the importance of randomized clinical trials in reshaping treatment approaches and the surprising underperformance of beta blockers in the study [33][36] 2. **Future Studies**: Ongoing studies, including Acacia HCM, are expected to provide further insights into the efficacy of aficamtan in different patient populations [82] 3. **Regulatory Pathway**: Cytokinetics is preparing a supplemental NDA to include MAPLE HCM results in labeling following the potential approval of aficamtan [81][82] Conclusion - The data presented at the ESC conference significantly bolster the case for aficamtan as a first-line treatment for obstructive HCM, potentially leading to a paradigm shift in clinical practice and future treatment guidelines [26][31][81]