The shares of biotechnology firm Cytokinetics are approaching what may be one of the most consequential weeks in the company’s recent timeline. Investor attention is intensely focused on an imminent regulatory verdict from the U.S. Food and Drug Administration (FDA) for its cardiac drug, aficamten (MYQORZO). This comes fresh on the heels of a significant regulatory advance in Europe.
The U.S. Deadline Takes Center Stage
The primary catalyst for current stock volatility is the pending FDA decision. The agency is reviewing the New Drug Application for aficamten, with a Prescription Drug User Fee Act (PDUFA) action date set for December 26, 2025. Market participants widely acknowledge that securing U.S. approval would fundamentally alter the commercial prospects for both the drug and the company. As of recent trading, the stock has been fluctuating between $60.45 and $63.80, currently quoted at approximately $63.00.
In a related development, Grabar Law Office has initiated an inquiry into the company’s disclosures concerning the FDA review process, adding another layer for investors to monitor.
European Regulators Endorse Aficamten
Providing a tailwind for the company, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency issued a positive opinion on December 12, 2025, recommending marketing authorization for MYQORZO. The therapy is intended for treating symptomatic obstructive hypertrophic cardiomyopathy (oHCM) in adults. This recommendation paves the way for a final decision from the European Commission, anticipated in the first quarter of 2026.
Should investors sell immediately? Or is it worth buying Cytokinetics?
Compelling Clinical Trial Evidence
The favorable European assessment is grounded in data from the Phase 3 SEQUOIA-HCM clinical study. Results demonstrated that patients receiving aficamten achieved an average improvement in peak oxygen uptake (pVO2) of 1.8 ml/kg/min. This contrasted with a change of 0.0 ml/kg/min observed in the placebo group. The difference was statistically highly significant, with a p-value of 0.000002.
This robust data has also garnered positive analyst commentary. On December 12, Serge Belanger of Needham reaffirmed a “Buy” rating for Cytokinetics stock, setting a price target of $72.00. Belanger highlighted potential advantages of the drug candidate over competing therapies, specifically noting a shorter half-life that could allow for more flexible dosing regimens.
The coming days will determine whether the momentum from Europe translates into a landmark approval in the critical U.S. market.
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