Cytokinetics, Incorporated
63.06+1.07 (+1.73%)
Oct 30, 10:24:28 AM EDT · NasdaqGS · CYTK · USD
Key Stats
Market Cap
7.55BP/E (TTM)
-Basic EPS (TTM)
-5.12Dividend Yield
0%Recent Filings
8-K
Aficamten NDA progresses
Cytokinetics advanced its NDA for aficamten in oHCM through a Late Cycle Meeting with the FDA on September 15, 2025, discussing REMS and post-marketing requirements while expecting a differentiated label if approved. All GCP inspections passed without observations, and no GMP inspections are scheduled, keeping the PDUFA date at December 26, 2025. The company plans to draw the full $100.0 million Tranche 5 loan from Royalty Pharma around October 1, 2025. Yet regulatory reviews carry risks of delays or denials.
8-K
Aficamten data boosts HCM prospects
Cytokinetics unveiled fresh data on aficamten at the European Society of Cardiology Congress 2025, revealing its edge over metoprolol in enhancing cardiac structure and function in obstructive hypertrophic cardiomyopathy patients from the MAPLE-HCM trial, with simultaneous publications in JACC and Heart Rhythm. Long-term analysis from FOREST-HCM showed a mere 1.5% annual atrial fibrillation incidence, aligning with HCM prediction models, while integrated safety data across trials confirmed tolerability akin to placebo. Aficamten awaits FDA approval by December 26, 2025. Risks persist in regulatory outcomes.
8-K
Aficamten beats metoprolol in HCM trial
Cytokinetics announced positive primary results from the MAPLE-HCM Phase 3 trial on August 30, 2025, showing aficamten superior to metoprolol in improving exercise capacity for patients with symptomatic obstructive hypertrophic cardiomyopathy. Aficamten boosted peak oxygen uptake by 1.1 mL/kg/min after 24 weeks, versus a 1.2 mL/kg/min drop with metoprolol, with consistent benefits across subgroups and superiority in five of six secondary endpoints like NYHA class and symptoms. Aficamten shines brighter. Safety profiles were comparable, though aficamten saw fewer dose reductions; the FDA's PDUFA date looms December 26, 2025.
8-K
Board appoints independent director
Cytokinetics appointed James M. Daly to its Board on August 19, 2025, filling a vacant Class III seat through the 2028 annual meeting and adding him to the Compliance Committee. Deemed independent under SEC and Nasdaq rules, Daly receives standard non-employee compensation, including a $50,000 annual retainer, $7,500 for committee service, and an initial stock option grant for 27,450 shares valued at $700,000 vesting over three years. This bolsters governance expertise. No related transactions disclosed.
8-K
Q2 loss widens on aficamten prep
Cytokinetics reported Q2 2025 financials, posting a $134.4 million net loss amid ramped-up R&D and G&A expenses for aficamten's commercial push, yet revenues jumped to $66.8 million from Bayer milestones and licensing. Regulatory reviews advance, with FDA PDUFA set for December 26, 2025, and positive MAPLE-HCM results slated for August's ESC Congress. Cash stands at $1.0 billion. Approvals remain uncertain.
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