Cytokinetics Inc. - CYTK STOCK NEWS

Cytokinetics (Nasdaq: CYTK) will report its fourth quarter results on February 24, 2022, at 4:00 PM ET. Following this, a conference call with senior management is scheduled for 4:30 PM ET to discuss the operational and financial outcomes, along with future outlooks. Investors can access the call via Cytokinetics' website or by phone. An archived replay will be available until March 10, 2022. The company continues to focus on developing muscle activators and inhibitors, including products in late-stage clinical trials for conditions like heart failure and hypertrophic cardiomyopathy.

Cytokinetics announces the FDA's acceptance of its New Drug Application (NDA) for omecamtiv mecarbil, aimed at treating heart failure with reduced ejection fraction (HFrEF). The NDA has a PDUFA target action date of November 30, 2022, with a standard review process in place. Notably, the FDA does not plan to hold an advisory committee meeting on this application. This follows positive results from the GALACTIC-HF trial, which demonstrated a significant reduction in the risk of cardiovascular death or heart failure events compared to placebo. Cytokinetics is poised for a potential commercial launch of this treatment.

Cytokinetics (Nasdaq: CYTK) announced on January 31, 2022, the grant of stock options for 200,700 shares to 15 new employees as a material inducement for their employment. The options have an exercise price of $33.19 per share, matching the January 31 closing price, and will vest over four years. This grant complies with Nasdaq Listing Rule 5635(c)(4). Cytokinetics focuses on developing innovative treatments for muscle-related diseases, with ongoing clinical trials for drugs such as omecamtiv mecarbil and aficamten.

Cytokinetics announced positive results from Cohort 3 of the REDWOOD-HCM trial for aficamten, aimed at treating hypertrophic cardiomyopathy (HCM). The trial involved patients on disopyramide, showing significant reductions in left ventricular outflow tract gradients while maintaining ejection fractions above 50%. All 13 participants completed the study without serious adverse events. The findings support including this patient group in the upcoming SEQUOIA-HCM Phase 3 trial. Results are set for presentation at the American College of Cardiology Annual Session in April.

Cytokinetics announced the award of $100,000 in grants to five nonprofit organizations to enhance communications and outreach in heart failure, hypertrophic cardiomyopathy (HCM), and amyotrophic lateral sclerosis (ALS) communities. Each organization received $20,000 to support initiatives aimed at increasing reach and education for underserved populations. The 2022 Fellowship Program aims to bolster resources for patient advocacy organizations, enhancing awareness and support for patients. The call for proposals for the next program will be announced in Fall 2022.

Cytokinetics (CYTK) announced the grant of stock options for 90,000 shares to 9 new employees as an inducement for their employment, effective December 31, 2021. The options have an exercise price of $45.58 per share, matching the closing stock price on the grant date, and will vest over four years with a 10-year term. This move complies with the Nasdaq Listing Rule 5635(c)(4) and aligns with the company’s strategic focus on recruiting talent as it advances its muscle biology therapies, including the cardiac muscle activator omecamtiv mecarbil.

Cytokinetics has secured $300 million from Royalty Pharma to support the potential launch of omecamtiv mecarbil and the development of aficamten. The funding, structured in five tranches, includes an initial $50 million upon closing, followed by payments tied to clinical milestones. Royalty Pharma also acquired 4.5% to 3.5% royalties on aficamten's future sales. This capital enables Cytokinetics to maintain a cash runway for at least two years, supporting its commercialization and development efforts in the cardiovascular sector.

Cytokinetics announced that Robert I. Blum, CEO, will present virtually at the 40th Annual J.P. Morgan Healthcare Conference on January 11, 2022, at 4:30 pm ET. The presentation will be accessible via the Investors & Media section of the Cytokinetics website. A replay of the webcast will be available for 30 days post-event. Cytokinetics focuses on developing innovative muscle activators and inhibitors aimed at treating diseases affecting muscle performance. Their key candidates include omecamtiv mecarbil and aficamten, currently in advanced clinical trials.

Cytokinetics (Nasdaq: CYTK) and Ji Xing Pharmaceuticals have expanded their collaboration to develop omecamtiv mecarbil for heart failure treatment in Greater China. Cytokinetics will receive $70 million in committed capital, including $50 million from Ji Xing and $20 million from RTW Investments through common stock sales. Additionally, Cytokinetics could earn up to $330 million in milestone payments and royalties. This partnership aims to enhance patient access to innovative therapies for heart failure in a significant cardiovascular market.