Cytokinetics Inc Stock Price, News & Analysis

Cytokinetics announced the completion of patient enrollment in the Phase 3 METEORIC-HF trial, evaluating omecamtiv mecarbil in patients with heart failure with reduced ejection fraction (HFrEF). This trial aims to assess the drug's impact on exercise capacity. Following positive results from the GALACTIC-HF trial, a New Drug Application (NDA) is planned for submission in the second half of 2021. Topline results from METEORIC-HF are expected in early 2022, potentially providing further insights into treatment effectiveness.

Cytokinetics, Incorporated (Nasdaq: CYTK) announced CEO Robert I. Blum will participate in three virtual investor conferences. These include the 42nd Annual Goldman Sachs Healthcare Conference on June 9, 2021, JMP Securities Life Sciences Conference on June 16, 2021, and Raymond James Human Health Innovation Conference on June 21, 2021. Webcasts will be available on the company’s website and archived for 90 days. Cytokinetics focuses on muscle activators and inhibitors, with ongoing Phase 3 trials for omecamtiv mecarbil and CK-274.

Cytokinetics (Nasdaq: CYTK) announced the grant of stock options for 49,500 shares to eight new employees as a material inducement to their employment, approved by its Compensation and Talent Committee. The options have an exercise price of $21.83 per share, equal to the May 28, 2021 closing price, and will vest over four years. This initiative aligns with Nasdaq Listing Rule 5635(c)(4). Cytokinetics focuses on developing therapies targeting muscle performance, including omecamtiv mecarbil and CK-274, both of which are in advanced clinical stages.

Cytokinetics (CYTK) has renewed its partnership with The ALS Association to advance awareness and support for ALS care. This collaboration includes sponsorship of the 2021 ALS Roundtables and funding initiatives in the Bay Area. Cytokinetics plans to initiate the COURAGE-ALS Phase 3 trial for reldesemtiv in ALS patients later in 2021. The company continues to engage in educational programs and local fundraising events, demonstrating its commitment to improving the lives of individuals affected by ALS.

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.