Cytokinetics Q1 Earnings Beat, Aficamten Target Action Date Extended

Cytokinetics, Incorporated CYTK reported a net loss of $1.36 per share for the first quarter of 2025, narrower than the Zacks Consensus Estimate of a loss of $1.41. In the year-ago quarter, the company reported a net loss of $1.33 per share. (Find the latest EPS estimates and surprises on Zacks Earnings Calendar.)The year-over-year deterioration was due to higher operating expenses.Cytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing and commercializing muscle biology-directed drug candidates as potential treatments for debilitating diseases in which cardiac muscle performance is compromised.Collaboration revenues totaled $1.6 million, which missed the Zacks Consensus Estimate of $2 million. The top line was up from $0.8 million recorded in the year-ago quarter. Since the company does not have any approved product in its portfolio yet, it does not generate drug sales.Shares are up in pre-market trading.Cytokinetics’ shares have lost 27.8% year to date compared with the industry’s 2.3% decline.Image Source: Zacks Investment ResearchCYTK’s Q1 Results in DetailR&D expenses amounted to $99.8 million, up 22.4% year over year due to the advancement of clinical trials and higher personnel-related costs.General and administrative expenses surged 26.1% to $57.4 million due to investments in the commercial readiness of lead pipeline candidate aficamten and personnel-related expenses.As of March 31, 2025, the company had approximately $1.1 billion in cash, cash equivalents, and investments compared with $1.2 billion as of Dec. 31, 2024.Cytokinetics, Incorporated Price, Consensus and EPS Surprise Cytokinetics, Incorporated price-consensus-eps-surprise-chart | Cytokinetics, Incorporated QuoteCYTK’s Updates on AficamtenAficamten is a next-in-class cardiac myosin inhibitor for the treatment of obstructive hypertrophic cardiomyopathy (HCM).The FDA had earlier accepted CYTK’s new drug application (NDA) for lead pipeline candidate aficamten and assigned a standard review to the candidate with a target action date of Sept. 26, 2025.However, the regulatory body extended the target action date for the NDA to Dec. 26, 2025. Cytokinetics submitted the NDA for aficamten in obstructive HCM without an accompanying REMS, and the FDA accepted the same following pre-NDA discussions (wherein safety and risk mitigation were discussed).During the NDA review, the FDA requested that Cytokinetics submit a REMS consistent with the inherent characteristics of aficamten, which the company provided. The submission of a REMS has now been determined by the FDA to be a major amendment to the NDA, resulting in a standard three-month extension to the original target action date. Nonetheless, no additional clinical data or studies have been requested by the FDA.The regulatory body does not plan to convene an Advisory Committee meeting to review the NDA for aficamten. CYTK will participate in a late-cycle meeting with the FDA in June.CYTK received the Day 120 List of Questions from the Committee for Medicinal Products for Human Use of the European Medicines Agency regarding the Marketing Authorization Application for aficamten for the treatment of obstructive HCM.CYTK earlier entered into a collaboration and license agreement with Bayer BAYRY for the exclusive development and commercialization of aficamten in Japan for the treatment of patients with obstructive and non-obstructive HCM.The deal included an upfront payment of €50 million and milestone payments of €90 million. Cytokinetics is also eligible to receive up to €490 million in commercial milestone payments upon Bayer's achievement of certain sales milestones and tiered royalties on net sales of aficamten in Japan.Pharma giant Sanofi SNY has acquired the exclusive rights to develop and commercialize aficamten for the treatment of patients with obstructive and non-obstructive HCM in Greater China.Cytokinetics remains eligible to receive up to $150 million in development and commercial milestone payments from Sanofi as well as royalties in the low-to-high teens on future sales of aficamten in Greater China.Aficamten is also currently being evaluated in MAPLE-HCM, a phase III study of aficamten as monotherapy compared to metoprolol as monotherapy in patients with obstructive HCM and ACACIA-HCM, a phase III study of aficamten in patients with non-obstructive HCM. Enrollment is completed in the primary cohort of ACACIA-HCM and top-line results are expected in the first half of 2026.Other studies include CEDAR-HCM, a clinical trial of aficamten in a pediatric population with obstructive HCM. Enrollment is ongoing.CYTK’s Other Pipeline CandidatesOther pipeline candidates include omecamtiv mecarbil, a cardiac muscle activator, in patients with heart failure. CYTK is enrolling in the confirmatory phase III multi-center, double-blind, randomized, placebo-controlled trial, COMET-HF, to assess the efficacy and safety of omecamtiv mecarbil in patients with symptomatic heart failure with severely reduced ejection fraction.Additionally, Cytokinetics initiated AMBER-HFpEF, a phase II randomized, placebo-controlled, double-blind, multi-center, dose-finding clinical trial on CK-586 in patients with symptomatic heart failure with preserved ejection fraction (with left ventricular ejection fraction [LVEF] ≥ 60%). CYTK expects to complete patient enrollment of the first two cohorts in the second half of 2025.CYTK conducted the initial single ascending dose cohorts of the phase I randomized, double-blind, placebo-controlled clinical study of CK-4015089 (CK-089) in healthy human participants.CYTK’s Zacks RankCytokinetics currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here. 5 Stocks Set to DoubleEach was handpicked by a Zacks expert as the #1 favorite stock to gain +100% or more in 2024. While not all picks can be winners, previous recommendations have soared +143.0%, +175.9%, +498.3% and +673.0%.Most of the stocks in this report are flying under Wall Street radar, which provides a great opportunity to get in on the ground floor.Today, See These 5 Potential Home Runs >>Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Sanofi (SNY): Free Stock Analysis Report Bayer Aktiengesellschaft (BAYRY): Free Stock Analysis Report Cytokinetics, Incorporated (CYTK): Free Stock Analysis ReportThis article originally published on Zacks Investment Research (zacks.com).Zacks Investment ResearchWeiter zum vollständigen Artikel bei Zacks Weiter zum vollständigen Artikel bei Zacks