Cytokinetics Inc. - CYTK STOCK NEWS

Cytokinetics plans to offer $450 million in convertible senior notes due 2027 in a private offering, with an option for an additional $90 million. The notes will be senior, unsecured obligations accruing interest semi-annually and maturing on July 1, 2027. Proceeds will fund clinical development for aficamten in hypertrophic cardiomyopathy and support commercial capabilities for omecamtiv mecarbil and aficamten. A part of the proceeds will also repurchase existing convertible notes due 2026. The offering is subject to market conditions and will not be registered under the Securities Act.

Cytokinetics announced that the FDA will review its New Drug Application for omecamtiv mecarbil during a meeting on December 13, 2022. This investigational drug aims to treat heart failure with reduced ejection fraction (HFrEF). The FDA's PDUFA target action date is set for February 28, 2023. The drug has shown positive results in the GALACTIC-HF clinical trial, significantly reducing cardiovascular deaths and heart failure events. Cytokinetics is preparing for potential commercialization following this approval process.

Cytokinetics has announced an extension of the PDUFA date for its new drug application (NDA) for omecamtiv mecarbil by three months to February 28, 2023, in response to a request from the FDA for additional pharmacokinetic analyses. The drug aims to treat worsening heart failure and has shown positive results in the GALACTIC-HF trial. The company remains committed to bringing this first-in-class cardiac myosin activator to market.

Cytokinetics has announced the initiation of COURAGE-ALS OLE, an open-label extension study for the investigational drug reldesemtiv, aimed at assessing long-term safety in ALS patients. Participants from the previous COURAGE-ALS trial are eligible, continuing with a dosage of 300 mg twice daily for 48 weeks. The primary focus will be on adverse event incidence and secondary endpoints including respiratory insufficiency and survival time. Additionally, a Managed Access Program will be launched for earlier trial participants later this year.

Cytokinetics presented new echocardiographic data at the ASE Annual Scientific Sessions, highlighting the positive effects of aficamten in treating obstructive hypertrophic cardiomyopathy (HCM). In a study involving 41 patients, significant improvements were observed in cardiac structure and function after 10 weeks of treatment. Key findings include a reduction in left atrial volume index (p<0.01) and improved mitral valve dynamics, with the proportion of patients experiencing systolic anterior motion (SAM) decreasing from 85.7% to 35.7% (p=0.038). The findings suggest notable early signs of enhanced cardiac health.

Cytokinetics, Incorporated (Nasdaq: CYTK) announced that results from the REDWOOD-HCM analysis of aficamten will be presented at the ASE 33rd Annual Scientific Sessions from June 10-13, 2022. The presentation, titled "Early Cardiac Structural and Functional Reverse Remodeling in Obstructive Hypertrophic Cardiomyopathy After 10 Weeks of Aficamten Therapy," will be delivered by Dr. Theodore Abraham on June 11, 2022. A recording will be available on-demand starting July 11, 2022.

Cytokinetics (Nasdaq: CYTK) announced that CEO Robert I. Blum will participate in three upcoming investor conferences:

• Jefferies Healthcare Conference on June 9, 2022, at 10:00 AM ET in New York City.
• Goldman Sachs 43rd Annual Healthcare Conference on June 13, 2022, at 2:40 PM PT in Rancho Palos Verdes.
• JMP Securities Life Sciences Conference on June 15, 2022, at 3:00 PM ET in New York City.

Live webcasts will be available on Cytokinetics' website, with replays accessible for 90 days post-event.

Cytokinetics, a biopharmaceutical company, announced the granting of stock options for 179,100 shares to 23 new employees on May 31, 2022. The options, aimed as material inducements, have an exercise price of $39.90 per share, equal to its closing stock price on that date. The options will vest over four years, with 25% vesting after one year and the remainder monthly over three years. These grants comply with Nasdaq Listing Rule 5635(c)(4) and reflect the company's ongoing commitment to attracting talent as it advances its product pipeline focused on muscle performance.

Cytokinetics, Incorporated (CYTK) announced positive results from recent analyses involving investigational drugs aficamten and omecamtiv mecarbil, presented at Heart Failure 2022. Aficamten showed substantial reductions in left ventricular outflow tract (LVOT) gradients after up to 6 months of treatment, with favorable safety and tolerability. Meanwhile, omecamtiv mecarbil demonstrated increased treatment effects in patients with low blood pressure and maintained safety profiles. Both drugs target heart failure, with aficamten focusing on hypertrophic cardiomyopathy and omecamtiv mecarbil on heart failure with reduced ejection fraction.