Cytokinetics Inc. - CYTK STOCK NEWS

Cytokinetics (Nasdaq: CYTK) announces its participation in Rare Disease Day®, in collaboration with EURORDIS and NORD, aimed at raising awareness for over 300 million individuals with rare diseases. CEO Robert I. Blum emphasizes ongoing commitment through two Phase 3 clinical trials: SEQUOIA-HCM for aficamten targeting hypertrophic cardiomyopathy, and COURAGE-ALS for reldesemtiv aiming at amyotrophic lateral sclerosis. Both drug candidates hold Orphan Drug and Breakthrough Therapy Designations from the FDA, underscoring Cytokinetics’ focus on impactful, rare disease therapies.

Cytokinetics (CYTK) reported a net loss of $30.6 million in Q4 2021 and $215.3 million for the year, compared to a loss of $43.9 million and $127.3 million respectively in 2020. The company's revenue surged to $55.6 million in Q4 2021, driven by a licensing agreement with Ji Xing. With cash reserves of $623.7 million and additional capital from Royalty Pharma, it projects a cash runway exceeding two years. The FDA accepted the NDA for omecamtiv mecarbil, with a PDUFA date set for November 30, 2022, while enrollment for aficamten's SEQUOIA-HCM trial is now open.

Cytokinetics announced the initiation of the SEQUOIA-HCM Phase 3 clinical trial for aficamten, targeting symptomatic obstructive hypertrophic cardiomyopathy (HCM). This trial is designed to evaluate aficamten's efficacy in improving exercise capacity, heart failure symptoms, and functional class over 24 weeks. Following positive Phase 2 results showing significant reductions in left ventricular outflow tract pressure gradient, the trial will enroll 270 patients. Aficamten has received Breakthrough Therapy Designation from the FDA, highlighting its potential in HCM treatment.

Cytokinetics has announced a three-year collaboration with the American Heart Association (AHA) Bay Area to enhance education and awareness of heart disease. The partnership includes funding for initiatives like the Research Roundtable and support for local Heart Walks. Cytokinetics aims to elevate patient voices through new video content. The collaboration aligns with the company's commitment to addressing unmet needs in heart diseases. Heart disease remains a leading cause of death in the U.S., responsible for 659,000 deaths annually and an economic burden of $363 billion.

Cytokinetics (CYTK) announced topline results from the METEORIC-HF Phase 3 trial, which showed no effect of omecamtiv mecarbil on exercise capacity in patients with heart failure with reduced ejection fraction (HFrEF). The primary endpoint, change in peak oxygen uptake (pVO₂), did not differ from placebo after 20 weeks. However, the FDA has accepted the New Drug Application for omecamtiv mecarbil, supported by positive findings from the GALACTIC-HF trial, which indicated a significant reduction in cardiovascular events. Results will be presented at the upcoming American College of Cardiology’s annual meeting.

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.