Cytokinetics Inc Stock Price, News & Analysis

Cytokinetics announced the termination of the sublicense agreement for omecamtiv mecarbil with Amgen and Servier, effective March 18, 2021. All rights revert to Cytokinetics after this date. The investigational drug, designed for treating heart failure, recently showed positive results in the GALACTIC-HF Phase 3 trial, demonstrating a statistically significant reduction in cardiovascular events. The company plans regulatory interactions in 2021 to discuss these results and evaluate strategic options for co-commercialization and licensing.

Cytokinetics has announced new data from the FORTITUDE-ALS Phase 2 clinical trial of reldesemtiv, indicating stronger treatment effects in faster progressing ALS patients. The company previewed the design of the upcoming COURAGE-ALS Phase 3 trial, which aims to enroll around 555 patients to evaluate reldesemtiv's efficacy over 24 weeks. The trial will measure changes in the ALS Functional Rating Scale-Revised (ALSFRS-R). The data presented may impact CYTK investors' outlook and reflects Cytokinetics' ongoing commitment to ALS treatment advancements.

Cytokinetics has revealed promising interim results from its REDWOOD-HCM trial, demonstrating substantial reductions in left ventricular outflow tract gradient (LVOT-G) in patients with obstructive hypertrophic cardiomyopathy after treatment with CK-274. No dose interruptions occurred due to left ventricular ejection fraction dropping below 50%. The trial is progressing to Cohort 2, with enrollment expected to complete by Q1 2021, and full results anticipated mid-2021. The next-generation cardiac myosin inhibitor CK-274 shows potential as a treatment for HCM, targeting hypercontractility and improving patient outcomes.

Cytokinetics, Incorporated (Nasdaq: CYTK) announced additional results from the GALACTIC-HF clinical trial, highlighting the efficacy of omecamtiv mecarbil in patients with advanced heart failure and a low left ventricular ejection fraction (LVEF ≤28%). After a median follow-up of 21.8 months involving 8,256 patients, results showed a hazard ratio of 0.84 for the primary composite endpoint, indicating a significant reduction in heart failure events compared to placebo. These findings suggest omecamtiv mecarbil could offer a new treatment option for this high-risk population.

Cytokinetics (Nasdaq: CYTK) announced three poster presentations at the 31st International Symposium on ALS/MND, scheduled from December 9-11, 2020. Highlights include a Phase 3 trial design for reldesemtiv targeting ALS, and insights from previous trials regarding patient characteristics and drug development input from ALS patients and caregivers. The company is advancing its drug candidates, including omecamtiv mecarbil for heart failure and CK-274 for hypertrophic cardiomyopathies, indicating potential growth opportunities.

Cytokinetics (Nasdaq: CYTK) announced on November 30, 2020, the grant of stock options for 62,850 shares to six new employees as an inducement to join the company. The options have an exercise price of $16.80 per share, equal to the closing stock price on that day. Vested over four years, the options will vest 25% annually, with the remainder vesting monthly. This grant complies with Nasdaq Listing Rule 5635(c)(4). Cytokinetics focuses on developing treatments for muscle performance issues, including ongoing Phase 3 and 2 clinical trials for its drug candidates.

Cytokinetics announced that results from the Phase 3 GALACTIC-HF trial of omecamtiv mecarbil will be presented at the Global Cardiovascular Clinical Trialists Forum on December 6, 2020. This trial aims to enhance cardiac contractility in heart failure patients. The presentation will be led by John Teerlink, M.D. Following positive outcomes from GALACTIC-HF, Cytokinetics is preparing for discussions with regulatory bodies regarding omecamtiv mecarbil and is concurrently conducting the METEORIC-HF trial.

Cytokinetics (Nasdaq: CYTK) announced Amgen's termination of their collaboration on omecamtiv mecarbil, effective May 20, 2021. This move allows Cytokinetics to regain development and commercialization rights for the heart failure drug after positive results from the GALACTIC-HF trial, which demonstrated significant efficacy in reducing cardiovascular death or heart failure events. The company is now preparing for regulatory discussions and market research while evaluating potential partnerships. An upcoming conference call will provide further details on this transition.

Cytokinetics has appointed Nancy Wysenski to its Board of Directors, strengthening its commercial and market access expertise as the company advances its drug pipeline. Wysenski brings over 25 years of experience in biopharmaceuticals, having previously held senior roles at Vertex Pharmaceuticals and Endo Pharmaceuticals. Her expertise in commercialization and organizational leadership is expected to play a crucial role as Cytokinetics navigates regulatory processes and prepares for potential marketing authorizations for its key products, including omecamtiv mecarbil and reldesemtiv.