Cytokinetics Gains 11.4% in a Week: Is There More Room for Growth?

Shares of Cytokinetics, Incorporated CYTK have gained 11.4% in a week compared with the industry’s growth of 4.6%. In fact, the stock hit a new 52-week high of $66.98 on Nov. 12, 2025.

Last week, the company reported a narrower-than-expected loss for the third quarter of 2025. Adjusted loss per share (excluding debt conversion expense) of $1.54 was narrower than the Zacks Consensus Estimate of a loss of $1.59.

Investor optimism around a potential approval of its lead candidate, aficamten, for the treatment of patients with obstructive hypertrophic cardiomyopathy (HCM) in the United States is likely fueling the share price.

Will CYTK Get FDA Approval for HCM Drug?

Aficamten is an investigational selective, small molecule cardiac myosin inhibitor.

In May 2025, CYTK announced that the FDA has extended the target action date for the new drug application (NDA) seeking approval of aficamten for oHCM to Dec. 26, 2025.

The FDA had earlier set a target action date of Sept. 26, 2025.

In September, CYTK participated in a late-cycle meeting with the FDA regarding the NDA for aficamten, wherein the company discussed its proposed Risk Evaluation and Mitigation Strategy (“REMS”) program, including Elements to Assure Safe Use (“ETASU”) and anticipated post-marketing requirements.

Based on CYTK’s discussions and communications with the FDA to date, the company continues to expect a differentiated label and risk mitigation profile for aficamten, if approved by the FDA.

CYTK has submitted responses to the Day 120 List of Questions from the CHMP of the EMA related to the review of its marketing authorization application (MAA) for aficamten for obstructive HCM in the EU. It has now received the Day 180 List of Questions. CYTK expects a potential EMA decision regarding the MAA in the first half of 2026.

Positive Data on Aficamten Increases Chances of Approval

In August, Cytokinetics presented primary results from the late-stage MAPLE-HCM study in a Hot Line Session at the European Society of Cardiology Congress 2025 in Madrid, Spain.

Results demonstrated the superiority of aficamten to the standard-of-care beta-blocker metoprolol on all clinically relevant efficacy endpoints. Aficamten also showed superiority to metoprolol in five of six secondary endpoints. It had a larger effect on measures of symptoms, functional class, and left ventricular outflow tract gradients as compared to first-line standard-of-care metoprolol. Aficamten substantially improved functional class and reduced patient symptom burden.

These results raised hopes for a plausible FDA approval.

Road Ahead For CYTK

A possible approval of aficamten for obstructive HCM will be a significant boost for CYTK, given the market potential.

CYTK has a sound cash position, too, which increases the chances of successful commercialization. As of Sept. 30, 2025, the company had approximately $1.25 billion in cash, cash equivalents and investments.

Upon approval, aficamten will face competition from Camzyos (mavacamten), a first-in-class cardiac myosin inhibitor marketed by Bristol Myers Squibb BMY.

BMY obtained FDA approval of the drug in 2022 for the treatment of adults with symptomatic New York Heart Association class II-III obstructive HCM to improve functional capacity and symptoms.

Camzyos has put up a stellar performance. BMY also has a promising candidate, milvexian, in its cardiovascular pipeline.

CYTK’s Zacks Rank & Key Picks

Cytokinetics currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector are Alkermes ALKS and Amicus Therapeutics FOLD, each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

Alkermes’ EPS estimates for 2025 have increased to $1.96 from $1.82, while those for 2026 have risen from $1.70 to $1.77 in the past 30 days. The stock has gained nearly 9,2% year to date.

Alkermes’ earnings beat estimates in three of the trailing four quarters and missed the mark in one, delivering an average surprise of 4.58%.

In the past 60 days, estimates for Amicus Therapeutics’ 2025 EPS have increased to 34 cents from 31 cents. During the same time, EPS estimates for 2026 have decreased to 67 cents from 69 cents. Year to date, shares of FOLD have gained 1%.

 

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