Cytokinetics

Cytokinetics, Inc. is a biopharmaceutical company, which is focused on discovering, developing, and commercializing muscle activators and muscle inhibitors as potential treatments for people with debilitating diseases in which muscle performance is compromised and/or declining. The firm is developing small molecule drug candidates specifically engineered to impact muscle function and contractility. Its clinical-stage drug candidates include omecamtiv mecarbil, a novel cardiac myosin activator, CK-136, a novel cardiac troponin activator, reldesemtiv, a novel fast skeletal muscle troponin activator, aficamten, a novel cardiac myosin inhibitor, and CK-3772271, a novel cardiac myosin inhibitor. The company was founded by Ronald D. Vale, Lawrence S. B. Goldstein, James H. Sabry, and James A. Spudich in 1997 and is headquartered in South San Francisco, CA.

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Cytokinetics focuses on aficamten development post-FDA action, eyes international growth

Cytokinetics is navigating challenges post-CRL for omecamtiv mecarbil while focusing on aficamten's development.
Financially, the company is balancing increased expenses with revenue growth and strategic investments in R&D.
Key milestones for 2023 include FDA meetings for omecamtiv mecarbil and data expectations for aficamten.
The company's emphasis on aficamten's differentiation and clinical progress signals a strategic shift in focus.

Cytokinetics shifts focus to cardiovascular pipeline, optimistic outlook ahead

Cytokinetics focusing on cardiovascular pipeline progress, redirecting resources.
Optimistic outlook for aficamten and other cardiovascular drug candidates.
Financially stable with cash reserves and strategic cost-saving measures.

Cytokinetics reports strong Q2 progress, eyes market expansion opportunities

Cytokinetics made significant strides in Q2 2023, advancing key studies and reducing operating spending to enhance financial stability.
Positive data and progress in cardiovascular therapies showcase the company's potential in treating HCM and positioning in the market.
While facing challenges in stock performance and data disclosures, Cytokinetics remains poised for growth with opportunities in novel therapies and market expansion.

Cytokinetics excels in Q3 with aficamten progress and commercial readiness

Cytokinetics demonstrated strong operational and financial performance in Q3 2023, with a focus on advancing the aficamten program and preparing for potential commercialization.
While facing challenges related to data interpretation complexities and real-world beta blocker usage, the company remains well-positioned with compelling clinical aspects of aficamten.
Opportunities lie in potential partnerships for capital access, broad market potential across regions, and upcoming data disclosures driving market differentiation.

Cytokinetics excels with positive aficamten trial results and strategic focus

Cytokinetics' Q4 2023 marked a significant milestone with positive aficamten trial results, strong financial standing, and strategic focus on regulatory advancements and market expansion.
The company's strengths lie in aficamten's efficacy, financial stability, and potential for differentiated labeling, while challenges include adoption transitions and data analysis complexities.
Opportunities abound in accelerating NDA submission, expanding patient reach, engaging with payors, and leveraging data insights for enhanced patient outcomes and market positioning.
Overall, Cytokinetics is poised for growth and impact in 2024, with a clear roadmap for success in advancing aficamten and maximizing its therapeutic potential in the HCM market.

Cytokinetics advances aficamten for HCM treatment amid financial strength

Cytokinetics is making significant strides in advancing aficamten for HCM treatment, supported by positive results and regulatory engagements.
The company's financial strength and strategic focus on commercial readiness position it well for future growth and market penetration.
Challenges lie in addressing unmet needs in pediatric HCM, enrollment completion for ongoing trials, and establishing treatment credibility.
Opportunities exist in expanding diagnosis potential, developing competitive treatment options, and enhancing regulatory alignment for global market access.

Cytokinetics advances obstructive HCM treatment with strong financials and strategic focus

Cytokinetics is poised for growth with FDA submission for aficamten and strong financial position.
Strategic focus on commercial preparations and clinical trials signals a commitment to future success.
Challenges in market competition and education require targeted efforts for successful product launch.
Emphasis on patient-centric approach and category expansion positions the company for market leadership.

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Top-line Results from GALACTIC-HF Now Expected in Q4 2020; Commercial Readiness Underway

Cytokinetics Announces Vision 2025 and Outlines 2020 Corporate Milestones

Next-Generation Cardiac Myosin Inhibitor Advances In Clinical Trial Designed to Assess Effects Using Two-Week Dose Titration Schedule Next-Generation Cardiac Myosin Inhibitor Advances In Clinical Trial Designed to Assess Effects Using Two-Week Dose Titration Schedule

Cytokinetics Announces Start of Redwood-HCM, a Phase 2 Clinical Trial of CK-3773274

SOUTH SAN FRANCISCO, Calif., Dec.  18, 2019  (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to reldesemtiv for the treatment of amyotrophic lateral sclerosis (ALS). Previously reldesemtiv was granted orphan drug designation for the treatment of spinal muscular atrophy (SMA) by the FDA and by the European Medicines Agency. In collaboration with Astellas, Cytokinetics is developing reldesemtiv, a fast skeletal muscle troponin activator (FSTA), as a potential treatment for people with ALS, SMA and certain other debilitating diseases and conditions associated with skeletal muscle weakness and/or fatigue.

Cytokinetics Granted Orphan Drug Designation for Reldesemtiv for the Treatment of Amyotrophic Lateral Sclerosis

Subgroup Analyses of FORTITUDE-ALS on Effects of Reldesemtiv with and without Concomitant Radicava® (edaravone) or Rilutek® (riluzole) Subgroup Analyses of FORTITUDE-ALS on Effects of Reldesemtiv with and without Concomitant Radicava® (edaravone) or Rilutek® (riluzole)

Cytokinetics Announces New Results Presented at the International Symposium on ALS/MND

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SOUTH SAN FRANCISCO, Calif., Nov.  11, 2019  (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq:CYTK) today announced that additional results from COSMIC-HF (Chronic Oral Study of Myosin Activation to Increase Contractility in Heart Failure), a Phase 2 trial evaluating omecamtiv mecarbil in patients with chronic heart failure, will be presented in an Abstract Rapid Fire Oral presentation at the American Heart Association Scientific Sessions 2019 in Philadelphia on November 18, 2019. 

Cytokinetics Announces Additional Results From COSMIC-HF to be Presented at the American Heart Association Scientific Sessions 2019

SOUTH SAN FRANCISCO, Calif., Nov.  08, 2019  (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that it has agreed to sell an aggregate of $120.0 million principal amount of its 4.00% convertible senior notes due 2026, or the notes, in an underwritten public offering. Cytokinetics has granted the underwriters a 30-day option to purchase up to an additional $18.0 million aggregate principal amount of the notes in connection with the offering, solely to cover over-allotments. The aggregate principal amount of the offering was increased from the previously announced offering size of $100.0 million. The offering is expected to close on November 13, 2019, subject to customary closing conditions.

Cytokinetics Announces Pricing of Public Offering of Convertible Senior Notes

News of a public debt offering didn't go over well with investors.

Here's Why Cytokinetics Stock Tanked on Thursday

SOUTH SAN FRANCISCO, Calif., Nov.  06, 2019  (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that it expects to sell, subject to market and other conditions, an aggregate of $100.0 million principal amount of its convertible senior notes due 2026, or the notes, in an underwritten public offering. Cytokinetics expects to grant the underwriters a 30-day option to purchase up to an additional $15.0 million aggregate principal amount of the notes in connection with the offering, solely to cover over-allotments. All of the notes will be sold by Cytokinetics.

Cytokinetics Announces Proposed Public Offering of  Convertible Senior Notes

Cytokinetics, Incorporated (CYTK) CEO Robert Blum on Q3 2019 Results - Earnings Call Transcript

Faster Progressing Patients Who Received Reldesemtiv in the Trial Demonstrated Statistically Significant Differences in the Decline in ALSFRS-R Total Score Faster Progressing Patients Who Received Reldesemtiv in the Trial Demonstrated Statistically Significant Differences in the Decline in ALSFRS-R Total Score

Cytokinetics Announces Presentation of Additional Analyses From FORTITUDE-ALS at the 18th Annual NEALS Meeting

SOUTH SAN FRANCISCO, Calif., Sept.  26, 2019  (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that additional results from FORTITUDE-ALS (Functional Outcomes in a Randomized Trial of Investigational Treatment with CK-2127107 to Understand Decline in Endpoints – in ALS), the Phase 2 clinical trial of reldesemtiv in patients with amyotrophic lateral sclerosis (ALS), will be presented in a poster session at the 18th Annual Northeast Amyotrophic Lateral Sclerosis (NEALS) Meeting at the Opal Sands Resort in Clearwater Beach, FL.

Cytokinetics Announces Additional Results From FORTITUDE-ALS to be Presented at the 18th Annual NEALS Meeting

SOUTH SAN FRANCISCO, Calif., Sept.  26, 2019  (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that Robert I. Blum, President and Chief Executive Officer, is scheduled to present a corporate update at the Cantor Fitzgerald Global Healthcare Conference on Thursday, October 3, 2019 at 10:40 AM ET at the InterContinental New York Barclay Hotel in New York City.

Cytokinetics to Present at the Cantor Fitzgerald Global Healthcare Conference

Grants Support Community Engagement for Patient Advocacy Organizations Focused on Cardiovascular or Neuromuscular Diseases

Cytokinetics Announces Second Annual Communications Fellowship Program Call for Proposals

Pharmacokinetic/Pharmacodynamic Relationship in Humans Similar to Preclinical Findings

Cytokinetics Announces Data From Phase 1 Study of CK-3773274 at the HFSA 23ʳᵈ Annual Scientific Meeting

SOUTH SAN FRANCISCO, Calif., Sept.  06, 2019  (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced two poster presentations at the 23rd Annual Heart Failure Society of America (HFSA) Scientific Meeting in Philadelphia. The posters will be presented on September 13, 2019 and September 14, 2019, and will include the design of METEORIC-HF (Multicenter Exercise Tolerance Evaluation of  O  mecamtiv Mecarbil  Related to Increased Contractility in Heart Failure), the second Phase 3 clinical trial of omecamtiv mecarbil, and data from the Phase 1 study of CK-3773274 (CK-274), a novel cardiac myosin inhibitor, discovered by company scientists, in development for the potential treatment of HCM which may result from increased cardiac contractility.

Cytokinetics Announces Presentations at  the 23rd Annual HFSA Scientific Meeting

SOUTH SAN FRANCISCO, Calif., Sept.  03, 2019  (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that Robert I. Blum, President and Chief Executive Officer, is scheduled to present a corporate update at the following investor conferences:

Cytokinetics to Present at September Investor Conferences

Cytokinetics, Incorporated (CYTK) CEO Robert Blum on Q2 2019 - Earnings Call Transcript

Cytokinetics, Incorporated. (CYTK) CEO Robert Blum on Q1 2019 Results - Earnings Call Transcript

Cytokinetics announced that the phase 2 study treating patients with ALS failed to meet the primary endpoint; however, it believes the program can still be advanced to a phase 3 study.

Cytokinetics Suffers Trial Setback, But It Is Brushed Off By The Market

Shares of biotech Cytokinetics Inc. plunged 19% in premarket trade Monday.

Cytokinetics plunges 19% after Phase 2 trial of ALS drug fails to meet endpoints

Cytokinetics Inc. shares took a step back on Monday after the firm announced that its midstage trial for amyotrophic lateral sclerosis (ALS) failed to meet expectations.

What Cytokinetics New Study Means for ALS Patients

Cytokinetics (CYTK) doesn't possess the right combination of the two key ingredients for a likely earnings beat in its upcoming report. Get prepared with the key expectations.

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