Cytokinetics, Incorporated CYTK announced that the late-stage COMET-HF study on pipeline candidate, omecamtiv mecarbil, has started.

COMET-HF (Confirmation of Omecamtiv Mecarbil Efficacy Trial in Heart Failure) is a confirmatory phase III study of omecamtiv mecarbil in patients with symptomatic heart failure (HF) with severely reduced ejection fraction.

Year to date, Cytokinetics’ shares have lost 38.3% compared with the industry’s 8.3% decline.

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More on CYTK’s COMET-HF Study

Omecamtiv mecarbil is a novel investigational selective cardiac myosin activator in development for the potential treatment of HF with severely reduced ejection fraction.

The phase III COMET-HF study is being conducted in collaboration with Duke Clinical Research Institute, a leading academic research organization. The study is open to enrollment.

The multi-center, double-blind, randomized, placebo-controlled study is designed to assess the efficacy and safety of omecamtiv mecarbil in patients with symptomatic HF with severely reduced ejection fraction.

The primary endpoint of COMET-HF is the time to first event in the primary composite endpoint of cardiovascular death, first heart failure event, left ventricular assist device (LVAD) implantation or cardiac transplantation, or stroke.

Secondary endpoints will evaluate the risk of individual components, including heart failure hospitalization, cardiovascular death, and stroke, as well as the risk of irreversible morbidity/mortality based on the composite endpoint of cardiovascular death, LVAD or cardiac implantation, or stroke.

The study is expected to randomize approximately 1,800 patients in two arms equally to receive omecamtiv mecarbil or placebo.

Eligible patients will enter a two-week run-in period, following which all patients will undergo a two-week washout period before being randomized to receive omecamtiv mecarbil, up to a maximum dose of 50 mg twice daily based on the plasma concentration of omecamtiv mecarbil during the run-in period, or placebo. Patients will continue to receive omecamtiv mecarbil or placebo twice daily until at least 850 primary composite endpoint events have occurred in the trial.

However, patients who are intolerant to omecamtiv mecarbil, are non-adherent, or have either undetectable or excessive plasma concentrations of omecamtiv mecarbil will not be eligible for randomization.

CYTK’s Pipeline Progress

Cytokinetics recently announced that the FDA has accepted the company’s new drug application (NDA) for lead pipeline candidate, aficamten.

Aficamten is a next-in-class cardiac myosin inhibitor. The NDA is seeking approval for the candidate for the treatment of obstructive hypertrophic cardiomyopathy.

The regulatory body assigned the NDA a standard review and set a target action date of Sept. 26, 2025.

The FDA also informed the company that it is not planning to hold an advisory committee meeting to discuss the application.

A potential approval and the successful development of the candidate should be a significant boost for this late-stage, specialty cardiovascular biopharmaceutical company, CYTK, as it currently does not have any approved product in its portfolio.

Pharma giant Bayer AG BAYRY recently announced that it will acquire rights to aficamten in Japan. Per the financial terms of the agreement, Cytokinetics will receive an upfront payment of €50 million and an additional €90 million upon achieving milestones through commercial launch, including €20 million, which are near-term. In addition, Cytokinetics is eligible to receive up to €490 million in commercial milestone payments upon achieving certain sales milestones by Bayer and tiered royalties on net sales of aficamten in Japan.

CYTK’s Zacks Rank and Stocks to Consider

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

A couple of better-ranked stocks in the biotech sector are Spero Therapeutics SPRO and Castle Biosciences, Inc. CSTL, both carrying a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

In the past 60 days, estimates for Spero Therapeutics’ 2024 loss per share have narrowed from $1.59 to $1.29. Estimates for 2025 loss per share have narrowed from $1.54 to 79 cents.

Spero Therapeutics’ earnings beat estimates in two of the trailing four quarters and missed the mark on the other two occasions, delivering an average surprise of 94.42%.

In the past 60 days, estimates for Castle Biosciences’ 2024 loss per share have narrowed from 58 cents to 8 cents. Loss per share estimates for 2025 have narrowed from $2.13 to $1.88 during the same time frame. Year to date, shares of CSTL have surged 42.6%.

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

 

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