Shares of Cytokinetics CYTK gained 2.2% on Wednesday after the company began enrolling patients in its mid-stage study of CK-4021586 (CK-586), a cardiac myosin inhibitor, for treating heart failure patients. The intended patient population includes those with symptomatic heart failure with preserved ejection fraction (HFpEF) with left ventricular ejection fraction (LVEF) ≥60%.   

The primary goal of the phase II AMBER-HFpEF study is to evaluate the safety and tolerability profile of CK-586 compared to placebo in HFpEF patients. As secondary objectives, the study will also assess the effect of CK-586 on LVEF and NT-proBNP, and determine the candidate’s pharmacokinetics and pharmacokinetic/pharmacodynamic relationship. Other exploratory endpoints of the study include evaluating the effect of CK-586 on patient function, symptoms and measures of cardiac function.

Cytokinetics plans to enroll approximately 60 HFpEF patients in the phase II AMBER-HFpEF study who will receive CK-586 or placebo in three dose escalation cohorts. In the past three months, CYTK shares have lost 10.6% compared with the industry’s 8.7% decline. 

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CYTK’s Other Pipeline Developmental Programs

Cytokinetics is developing its lead investigational candidate, aficamten, a novel, oral and small-molecule cardiac myosin inhibitor, to reduce the hypercontractility associated with hypertrophic cardiomyopathy (HCM). A regulatory filing for aficamten to treat obstructive HCM is currently under review by the FDA. A final decision from the regulatory body is expected on Sept. 26, 2025. The FDA also informed the company that it is not planning to hold an advisory committee meeting to discuss the application.

Similar regulatory filings seeking approval for aficamten to treat obstructive HCM are also currently under review in other geographies, including the EU.

Cytokinetics is also evaluating aficamten monotherapy in its phase III MAPLE-HCM study compared to metoprolol monotherapy in patients with obstructive HCM (enrollment completed) and ACACIA-HCM, a phase III study of aficamten in patients with non-obstructive HCM (enrolment ongoing). Other studies include CEDAR-HCM, a clinical study of aficamten in a pediatric population with obstructive HCM. Enrollment is ongoing in CEDAR-HCM.

Another pipeline candidate is omecamtiv mecarbil, a cardiac muscle activator, which is being developed for patients with heart failure. Last month, Cytokinetics initiated COMET-HF, a confirmatory phase III study to assess the efficacy and safety of the candidate in patients with symptomatic heart failure with severely reduced ejection fraction.

Cytokinetics, Incorporated Price and Consensus

Cytokinetics, Incorporated price-consensus-chart | Cytokinetics, Incorporated Quote

CYTK’ Zacks Rank & Stocks to Consider

Cytokinetics currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks from the sector are Castle Biosciences CSTL, BioMarin Pharmaceutical BMRN and CytomX Therapeutics CTMX. While CSTL and BMRN currently sport a Zacks Rank #1 (Strong Buy) each, CTMX carries a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

In the past 30 days, Castle Biosciences’ earnings estimates for 2024 have increased from 34 cents to 39 cents per share. During the same timeframe, loss per share for 2025 has remained constant at $1.84. In the past three months, shares of Castle Biosciences have plunged 16.3%.

CSTL’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 172.72%.

In the past 30 days, estimates for BioMarin Pharmaceutical’s 2024 earnings per share have Improved from $3.28 to $3.29. Estimates for 2025 earnings per share have decreased from $4.05 to $4.02 during the same timeframe. In the past three months, BioMarin Pharmaceutical shares have lost 11.9%.

BMRN’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 28.7%.

In the past 30 days, estimates for CytomX Therapeutics’ 2024 loss per share have remained constant at 5 cents. Estimates for 2025 loss per share have remained constant at 35 cents during the same timeframe. In the past three months, shares of CytomX Therapeutics have lost 22.4%.

CTMX’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 115.70%.

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