Cytokinetics Inc. - CYTK STOCK NEWS

The FDA has posted briefing documents for a meeting of the Cardiovascular and Renal Drugs Advisory Committee on December 13, 2022, to review Cytokinetics' New Drug Application (NDA) for omecamtiv mecarbil, a cardiac myosin activator aimed at treating heart failure with reduced ejection fraction (HFrEF). The NDA is based on promising results from the Phase 3 GALACTIC-HF trial, showing a significant reduction in cardiovascular death or heart failure events. The PDUFA target action date for the NDA is set for February 28, 2023.

Cytokinetics announced findings from the FORTITUDE-ALS trial at the 33rd International Symposium on ALS/MND that the predicted survival risk score demonstrates a strong correlation with the decline in ALSFRS-R. This analysis supports the ongoing COURAGE-ALS Phase 3 trial, with inclusion criteria aimed at enriching enrollment for faster progressors of ALS. COURAGE-ALS is expected to enroll around 555 patients, with a primary endpoint assessing changes in ALSFRS-R over 24 weeks. Continued research in this area responds to the urgent need for new therapies for ALS patients.

Cytokinetics announced the initiation of a Phase 1 clinical trial for CK-3828136 (CK-136), a cardiac troponin activator, aimed at treating heart failure with reduced ejection fraction (HFrEF). The trial includes randomization and double-blinding, assessing safety, tolerability, and pharmacokinetics in healthy participants. CK-136 is designed to enhance myocardial contractility through an allosteric mechanism, potentially differentiating its effects on heart failure. Cytokinetics is expanding its cardiovascular portfolio, following promising developments in earlier studies.

Cytokinetics, incorporated (Nasdaq: CYTK), announced on December 2, 2022, that it granted stock options to purchase 146,100 shares of common stock to 14 new employees as an inducement for their employment effective November 2022. The options have an exercise price of $42.50 per share, which matches the closing price on the grant date, and will vest over four years. These options are consistent with Nasdaq Listing Rule 5635(c)(4) and are part of the company’s ongoing commitment to attract talent while preparing for the potential commercialization of its cardiac muscle activator, omecamtiv mecarbil.

Cytokinetics (Nasdaq: CYTK) announced a poster presentation for the FORTITUDE-ALS Phase 2 clinical trial of reldesemtiv, focusing on ALS survival predictions. This session will occur during the Virtual 33rd International Symposium on ALS/MND from December 6-9, 2022. Dr. Tyrell Simkins will present the ENCALS Predictive Survival Model on December 8, 2022, from 5:00-6:30 PM GMT. Cytokinetics specializes in muscle performance therapies and is advancing several clinical candidates, notably omecamtiv mecarbil and aficamten, targeting significant heart conditions and diseases.

Cytokinetics announced new data from the GALACTIC-HF trial, presented at the American Heart Association Scientific Sessions 2022. The trial revealed that treatment with omecamtiv mecarbil significantly reduced heart failure hospitalizations and associated costs, averaging a 26.9% cost reduction over three years. Analysis showed omecamtiv mecarbil reduced cardiovascular death and heart failure events in North American patients with EF ≤30%. The treatment's efficacy showed no significant gender differences despite worse quality of life for women at baseline.

Cytokinetics (CYTK) reported a net loss of $142.3 million ($1.52/share) in Q3 2022, up from $76.1 million ($0.95/share) in Q3 2021. Despite the loss, cash and equivalents stood at $896.2 million. Revenue for Q3 was $2.5 million, with a significant nine-month increase to $92.6 million, primarily due to $87 million from mavacamten royalties. The company is preparing for the potential U.S. launch of omecamtiv mecarbil and advancing various clinical trials, including aficamten and COURAGE-ALS, with results expected in 1H 2023.

Cytokinetics, Inc. (Nasdaq: CYTK) announced the grant of stock options for 202,500 shares to 20 new employees as an inducement to their employment, effective October 31, 2022. The options have an exercise price of $43.66 per share and will vest over four years. A quarter of the options will vest after one year, with the remainder vesting monthly over the following 36 months. This grant complies with Nasdaq Listing Rule 5635(c)(4) and aims to attract and retain talent critical to the company's growth in developing muscle performance treatments.

Cytokinetics announces three poster presentations at the American Heart Association Scientific Sessions 2022, from November 5 to 7, 2022, in Chicago, IL. Presentations will cover: 1) Heart failure patient profiles from the Get With The Guidelines®-Heart Failure Registry, 2) Healthcare resource use and cost analysis for North American patients likely to benefit from omecamtiv mecarbil, and 3) Analysis of sex differences in the GALACTIC-HF trial. Key presenters include experts from Duke University Medical Center and Yale School of Medicine.