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On Wednesday, Citi analysts adjusted their stance on Cytokinetics (NASDAQ:CYTK), reducing the price target from the previous $86.00 to $80.00, while still advocating a Buy rating for the stock. The stock, which has fallen over 20% in the past week and is trading near its 52-week low of $32.74, faces headwinds following its recent earnings report for the first quarter of 2025, where management discussed a regulatory hurdle encountered—a three-month postponement of the PDUFA date for its drug candidate, aficamten. According to InvestingPro data, analyst consensus remains bullish with price targets ranging from $41 to $120.
The management team at Cytokinetics acknowledged the risk taken by opting not to include a Risk Evaluation and Mitigation Strategy (REMS) proposal with its New Drug Application (NDA) earlier in the year. This decision was based on previous discussions with the FDA and advice from consultants. Analysts interpret this move as an attempt by the company to secure approval without the constraints of a stringent REMS program. InvestingPro subscribers can access 8 additional key insights about CYTK’s regulatory developments and market position through exclusive ProTips.
Despite the delay and investor frustration, analysts emphasize that the three-month wait is likely the sole setback, with no expected impact on the drug’s market success. They anticipate that aficamten, once approved, will be subject to a more lenient REMS program compared to its competitor, Camzyos.
Additionally, Cytokinetics reported accelerated enrollment in the Phase 3 ACACIA trial for aficamten in non-hypertrophic cardiomyopathy (nHCM), potentially shortening the timeline by six months. With Camzyos no longer in development for nHCM, a positive outcome from the ACACIA trial in the first half of 2026 could significantly benefit the company.
In other recent news, Cytokinetics announced its financial results for the first quarter of 2025, reporting a net loss of $161.4 million or $1.36 per share. The company’s revenue was $1.6 million, missing the forecasted $3.6 million. Despite the revenue shortfall, earnings per share slightly exceeded expectations, with analysts predicting a loss of $1.37 per share. JMP Securities maintained its Market Outperform rating for Cytokinetics, reaffirming a $78 price target, and expressed confidence in the company’s drug aficamten despite the FDA’s decision to extend the PDUFA date by three months to December 26, 2025. The extension allows the FDA more time to review the New Drug Application for aficamten, submitted without a REMS plan. JMP Securities anticipates that aficamten will be approved with a differentiated REMS, potentially offering less stringent monitoring requirements. Additionally, Cytokinetics has been advancing its regulatory activities in Europe and China, with potential market entries anticipated in 2026. The company is also preparing for the commercial launch of aficamten in the United States, pending FDA approval.
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