Cytokinetics Inc. - CYTK STOCK NEWS

Cytokinetics, Incorporated (NASDAQ: CYTK) announced the discontinuation of the Phase 3 COURAGE-ALS clinical trial for reldesemtiv due to recommendations from the Data Monitoring Committee (DMC). After an interim analysis showed no effect on the primary or key secondary endpoints, the study will conclude, affecting approximately 460 patients who participated. Cytokinetics plans to cease all treatments with reldesemtiv and will notify regulatory agencies about the findings. The company expressed disappointment over the trial's outcome and will evaluate future steps for its neuromuscular development programs.

Cytokinetics, Incorporated (Nasdaq: CYTK) has released its inaugural Corporate Responsibility Report, emphasizing its commitment to patient centricity, sustainability, ethics, and diversity. CEO Robert I. Blum highlighted the importance of aligning corporate goals with community well-being. The report focuses on three key pillars: keeping patients at the center, advancing a diverse culture, and supporting sustainable communities. It aims to enhance transparency and accountability, with plans for annual updates on progress. Cytokinetics, a biopharmaceutical company, specializes in developing therapies for muscle-related diseases.

Cytokinetics, Incorporated (Nasdaq: CYTK) announced its participation in three key investor conferences. CEO Robert I. Blum will present virtually at the Oppenheimer 33rd Annual Healthcare Conference on March 13, 2023. He will also engage in a fireside chat at the Barclays Global Healthcare Conference on March 15, 2023, in Miami Beach, FL. Additionally, management will conduct one-on-one meetings at the Jefferies 2023 Biotech on the Bay Summit on March 16, 2023, also in Miami Beach. Interested parties can access live webcasts of these events through Cytokinetics' website, with replays available for 90 days.

Cytokinetics announced positive results from its Phase 2 clinical trial, REDWOOD-HCM, for aficamten in patients with non-obstructive hypertrophic cardiomyopathy (nHCM). The trial demonstrated significant improvements in heart failure symptoms and cardiac biomarkers. Key findings include a 66% average decrease in NT-proBNP at 10 weeks, with 54% of patients experiencing an improvement in NYHA Functional Class. The treatment was well-tolerated, with the majority of patients achieving optimal doses without serious adverse events. Following these results, Cytokinetics plans to advance aficamten into a pivotal Phase 3 trial. An investor event will take place on March 6, 2023.

Cytokinetics announced the grant of stock options for 21,450 shares to five new employees as material inducements to their employment. The stock options have an exercise price of $43.36 per share, equal to the closing price on February 28, 2023. Vesting occurs over four years, with 25% on the one-year anniversary and the rest monthly thereafter. Each option has a 10-year term under the company's 2004 Equity Incentive Plan. Cytokinetics focuses on developing therapies for muscle-related diseases, including heart failure and amyotrophic lateral sclerosis (ALS), emphasizing its innovation in muscle biology.

Cytokinetics, Incorporated (CYTK) reported a net loss of $137.4 million or $1.45 per share for Q4 2022, compared to $30.6 million or $0.36 per share in Q4 2021. For the full year 2022, the net loss totaled $389.0 million or $4.33 per share. Cash and investments were $829.3 million as of December 31, 2022, providing over two years of cash runway. The FDA issued a Complete Response Letter regarding the NDA for omecamtiv mecarbil, indicating insufficient evidence of effectiveness. The company also anticipates revenue of up to $5 million in 2023 and a $50 million milestone payment from Royalty Pharma.

Cytokinetics announced that the FDA issued a Complete Response Letter (CRL) regarding the NDA for omecamtiv mecarbil, a treatment for heart failure with reduced ejection fraction. The FDA determined that the GALACTIC-HF trial results do not provide sufficient evidence of effectiveness for reducing heart failure events or cardiovascular deaths, necessitating additional clinical trials. Cytokinetics plans to meet with the FDA to discuss potential next steps but has no plans for further trials of omecamtiv mecarbil. The company's focus continues on aficamten, a cardiac myosin inhibitor, which is in a Phase 3 trial.

Cytokinetics has announced three poster presentations at the upcoming American College of Cardiology 72^nd Annual Scientific Session (ACC.23) in New Orleans, occurring from March 4-6, 2023. The presentations highlight the company's innovative drug candidates, including Aficamten and Omecamtiv Mecarbil. Notable sessions include:

• Aficamten in symptomatic non-obstructive hypertrophic cardiomyopathy presented by Dr. Ahmad Masri on March 5.
• Long-term efficacy and safety of Aficamten for symptomatic obstructive hypertrophic cardiomyopathy by Dr. Sara Saberi on March 5.
• Applicability of the GALACTIC-HF trial for hospitalized heart failure patients presented by Dr. Josephine Harrington on March 4.

Cytokinetics (Nasdaq: CYTK) is participating in Rare Disease Day on February 28, 2023, alongside EURORDIS and NORD to raise awareness for over 300 million individuals affected by rare diseases. CEO Robert I. Blum emphasized the company's commitment to enhancing access to diagnosis, treatment, and care for these patients. Cytokinetics is developing aficamten, a cardiac myosin inhibitor for hypertrophic cardiomyopathy (HCM), currently in a Phase 3 trial, SEQUOIA-HCM. Additionally, reldesemtiv, aimed at treating amyotrophic lateral sclerosis (ALS), is under evaluation in COURAGE-ALS, also a Phase 3 trial. Both drug candidates have received Orphan Drug Designation from the FDA.