Cytokinetics Inc Stock Price, News & Analysis

Cytokinetics announced results from the GALACTIC-HF trial indicating that treatment with omecamtiv mecarbil improves clinical outcomes in heart failure patients, particularly those with lower ejection fractions. Findings presented at the American College of Cardiology showed a 15% and 17% relative risk reduction in heart failure events for patients with EF ≤28%. No adverse effects on heart rate or renal function were reported. These results support advancing towards a NDA submission in the second half of 2021.

Cytokinetics (Nasdaq: CYTK) presented new findings on heart failure (HF) and hypertrophic cardiomyopathy (HCM) at ACC.21. The analysis highlighted a staggering $27 billion in Medicare spending for HF care over three years, emphasizing the economic burden of hospitalization and readmission. Additionally, a study on obstructive HCM showed increased cardiovascular comorbidities and medication use over two years. These results underscore the need for innovative therapies to improve patient outcomes in these conditions.

Cytokinetics announced three presentations at the American College of Cardiology's 70th Annual Scientific Session scheduled from May 15-17, 2021. A highlight will be a secondary analysis of omecamtiv mecarbil from the GALACTIC-HF trial, focusing on its effects related to patient ejection fraction. Presented by Dr. John Teerlink, the analysis will take place during the Late Breaking Clinical Trial session on May 17 at 9:00 AM ET. Additional poster presentations will cover topics related to heart failure and patient care costs following hospitalization.

Cytokinetics reported a Q1 2021 net loss of $47.1 million ($0.66/share), up from a $39.4 million loss in Q1 2020. Revenue rose to $6.5 million, compared to $3.8 million last year, attributed to increased R&D from collaborations. Cash and investments totaled $460.2 million as of March 31, 2021. The company plans to submit a New Drug Application for omecamtiv mecarbil in the second half of 2021 following positive discussions with the FDA. Additionally, results from the REDWOOD-HCM study are anticipated mid-year as Cytokinetics expands its clinical development programs.

Cytokinetics (CYTK) has initiated patient enrollment in REDWOOD-HCM OLE, an open-label extension study aimed at evaluating the long-term safety and tolerability of CK-274 in patients with symptomatic obstructive hypertrophic cardiomyopathy (oHCM). This follows the completion of the REDWOOD-HCM Phase 2 trial. The study's primary endpoint will focus on adverse events and left ventricular ejection fraction (<50%). CK-274, a next-in-class cardiac myosin inhibitor, aims to improve the quality of life for oHCM patients, an area with limited treatment options.

Cytokinetics, Incorporated (Nasdaq: CYTK) will hold its Annual Meeting of Stockholders on May 12, 2021, at 10:30 AM PT at its headquarters in South San Francisco. Stockholders of record as of March 22, 2021, can vote in person or via proxy. The meeting will feature a presentation from CEO Robert I. Blum on the company's performance. Due to COVID-19, health precautions including masks and temperature checks will be enforced. A live webcast will be available on the company's website, with an archived replay accessible until May 26, 2021.

Cytokinetics has commenced enrollment in Cohort 3 of its Phase 2 clinical trial, REDWOOD-HCM, evaluating CK-274 for hypertrophic cardiomyopathy (HCM) patients on disopyramide. This cohort aims to assess safety, tolerability, and pharmacokinetics of CK-274. Preliminary findings from earlier cohorts indicated significant reductions in left ventricular outflow tract gradients without major safety concerns. Results from Cohorts 1 and 2 are anticipated mid-2021. CK-274 has been developed to target hypercontractility in HCM, with no FDA-approved treatments currently available.

Cytokinetics granted stock options to purchase 69,800 shares to six new employees as an inducement for employment, effective April 30, 2021. The options have an exercise price of $25.44 per share, equal to the closing stock price on that date. Vesting occurs over four years, with the first quarter vesting after one year and the remainder monthly thereafter. This grant was sanctioned by the Compensation and Talent Committee and complies with Nasdaq rules. The company focuses on muscle-related drug development and prepares for regulatory action on its cardiac muscle activator, omecamtiv mecarbil.

Cytokinetics (Nasdaq: CYTK) will report its first quarter results on May 6, 2021, at 4:00 PM Eastern Time, followed by a conference call at 4:30 PM. This call will discuss operational and financial results and the company's future outlook. Investors can access the call via the company's website or by dialing designated numbers. An archived replay will be available until May 20, 2021. Cytokinetics specializes in muscle activators and inhibitors for treating diseases affecting muscle performance, with ongoing clinical trials for its drug candidates.