Cytokinetics Wins FDA Approval for Cardiovascular Drug, Stock up

Cytokinetics, Incorporated CYTK announced that the FDA approved its lead pipeline candidate, aficamten, for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) to improve functional capacity and symptoms.This marks the company’s first FDA-approved product, transforming Cytokinetics from a development-stage biotech into a commercial-stage company.The candidate was approved under the brand name Myqorzo.Shares are up in pre-market trading. Cytokinetics’ shares have surged 92.2% in the last six months compared with the industry’s 25.7% gain.Image Source: Zacks Investment ResearchMore on CYTK’s Cardiovascular DrugMyqorzo is an allosteric, reversible inhibitor of cardiac myosin motor activity. It is designed to address the underlying pathophysiology of oHCM. By reducing cardiac contractility, the drug lowers left ventricular outflow tract (LVOT) obstruction, a primary driver of symptoms such as shortness of breath, chest pain and exercise intolerance.The FDA approval was supported by robust results from the pivotal phase III study SEQUOIA-HCM. Myqorzo demonstrated statistically significant and clinically meaningful improvements in exercise capacity, increasing peak oxygen uptake (pVO???) by 1.8 mL/kg/min at 24 weeks, compared to baseline in patients treated with Myqorzo versus 0.0 mL/kg/min in patients treated with placebo.Benefits were consistent across all prespecified subgroups, including patients on background beta-blocker therapy.From a safety perspective, Myqorzo was generally well tolerated. Treatment-emergentt serious adverse events occurred in 5.6% of patients on Myqorzo and 9.3% of patients on placebo.However, the label includes a boxed warning for heart failure risk and requires echocardiographic monitoring under a REMS program.What Does the Approval Mean for CYTK?The approval of Myqorzo is a significant boost for CYTK, given the market potential for oHCM market.The oHCM market represents a meaningful commercial opportunity, with a substantial population of symptomatic patients who have historically had limited pharmacologic options beyond beta-blockers, calcium channel blockers, or invasive procedures. The approval positions Cytokinetics as a key player in this growing specialty cardiology segment.Hypertrophic cardiomyopathy (HCM) is the most prevalent monogenic inherited cardiovascular disease, with more than 300,000 patients diagnosed in the United States. However, an estimated 400,000 to 800,000 additional individuals remain undiagnosed. Approximately half of all HCM patients have oHCM, while the remaining half have non-obstructive HCM (nHCM).The drug is expected to be available in the United States in the second half of January 2026, setting the stage for near-term revenue generation.The drug was approved in China earlier in the month. The Committee for Medicinal Products for Human Use of the European Medicines Agency has also adopted a positive opinion recommending marketing authorization in the European Union for Myqorzo. A decision is expected in the first quarter of 2026.However, successful commercialization of the drug holds the key.Myqorzo 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 since approval.CYTK’s Zacks Rank & Key PicksCytokinetics currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the pharma/biotech sector are CorMedix CRMD and Amicus Therapeutics FOLD, each 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 CorMedix’s 2025 EPS have increased from $1.85 to $2.87. EPS estimates for 2026 have moved up from $2.49 to $2.88 during the same period. CRMD stock has risen 48.3% year to date. CorMedix’s earnings beat estimates in each of the trailing four quarters, with an average surprise of 27.04%.In the past 60 days, estimates for Amicus Therapeutics’ 2025 EPS have increased to 36 cents from 31 cents. During the same time, EPS estimates for 2026 have decreased to 67 cents from 70 cents. Year to date, shares of FOLD have gained 50.6%. 5 Stocks Set to DoubleEach was handpicked by a Zacks expert as the favorite stock to gain +100% or more in the months ahead. They includeStock #1: A Disruptive Force with Notable Growth and ResilienceStock #2: Bullish Signs Signaling to Buy the DipStock #3: One of the Most Compelling Investments in the MarketStock #4: Leader In a Red-Hot Industry Poised for GrowthStock #5: Modern Omni-Channel Platform Coiled to SpringMost of the stocks in this report are flying under Wall Street radar, which provides a great opportunity to get in on the ground floor. While not all picks can be winners, previous recommendations have soared +171%, +209% and +232%.Download Atomic Opportunity: Nuclear Energy's Comeback free today.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 Bristol Myers Squibb Company (BMY): Free Stock Analysis Report Amicus Therapeutics, Inc. (FOLD): Free Stock Analysis Report Cytokinetics, Incorporated (CYTK): Free Stock Analysis Report CorMedix Inc (CRMD): 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