Cytokinetics Inc. - CYTK STOCK NEWS

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.

Cytokinetics, Incorporated (Nasdaq: CYTK) will report its fourth quarter results on March 1, 2023, at 4:00 PM Eastern Time. Following this, senior management will host a conference call at 4:30 PM to discuss financial results and future outlook. The call will be webcasted and accessible through Cytokinetics' website. The company specializes in muscle activators and inhibitors for treating diseases affecting muscle performance, with ongoing Phase 3 clinical trials for its drug candidates, omecamtiv mecarbil and aficamten. In 2023, Cytokinetics honors 25 years of innovation in muscle biology.

Cytokinetics (Nasdaq: CYTK) announced the grant of stock options for 87,600 shares to 13 new employees as a material inducement for their employment, effective January 31, 2023. The exercise price is set at $42.48, equivalent to the stock's closing price on the same day. The options will vest over four years, with a quarter vesting on the one-year anniversary and the remainder vesting monthly thereafter. This action complies with Nasdaq Listing Rule 5635(c)(4). Cytokinetics focuses on developing innovative muscle activators and inhibitors, with key products in late-stage clinical trials.

Cytokinetics has awarded a total of $100,000 in its fifth annual Communications Grant Program to five patient advocacy organizations focused on heart failure, hypertrophic cardiomyopathy (HCM), and amyotrophic lateral sclerosis (ALS). Each organization will receive $20,000 to support projects aimed at enhancing community outreach and education. The funded initiatives include increasing awareness, developing digital resources, and expanding access to healthcare services for underserved populations. The program reflects Cytokinetics’ commitment to addressing the unmet needs of these patient communities.

Cytokinetics (Nasdaq: CYTK) announced the granting of stock options for 130,000 shares to 6 new employees as an inducement for their employment. The options have an exercise price of $45.82 per share, equal to the closing stock price on December 30, 2022. The options will vest over four years, with one-fourth vesting on the one-year anniversary and the rest vesting monthly over the following 36 months. This grant complies with Nasdaq Listing Rule 5635(c)(4), emphasizing Cytokinetics’ commitment to attracting talent in its muscle biology research.

Cytokinetics (Nasdaq: CYTK) has announced that Robert I. Blum, President and CEO, will present at the 41st Annual J.P. Morgan Healthcare Conference on January 9, 2023, at 9:00 AM PT. The event will take place at the Westin St. Francis in San Francisco. Interested parties can access the live webcast on the Cytokinetics website, with a replay available for 30 days post-event. Cytokinetics focuses on developing muscle activators and inhibitors for conditions impacting muscle performance, including drugs like omecamtiv mecarbil and aficamten.

Cytokinetics announced that the FDA's Cardiovascular and Renal Drugs Advisory Committee voted 8 to 3 against the benefit-risk profile of omecamtiv mecarbil for heart failure with reduced ejection fraction (HFrEF). Despite this setback, Cytokinetics remains confident in the drug's potential, citing evidence from the Phase 3 GALACTIC-HF trial, which showed a statistically significant reduction in cardiovascular death and heart failure events. The FDA's decision on the new drug application (NDA) is expected by February 28, 2023.