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MyoKardia has commenced the Phase 3 VALOR-HCM clinical trial, dosing the first patient to assess the efficacy of mavacamten for obstructive hypertrophic cardiomyopathy (HCM) patients refusing existing therapies. The trial aims to provide evidence that mavacamten can reduce the need for invasive septal reduction therapy (SRT). With approximately 100 patients expected to enroll, the study includes a 16-week placebo-controlled phase and a long-term extension period. Previous trials have shown mavacamten's potential in alleviating symptoms and improving cardiac function.
MyoKardia, Inc. (Nasdaq: MYOK) announced that the FDA granted Breakthrough Therapy Designation to mavacamten for treating symptomatic, obstructive hypertrophic cardiomyopathy (HCM). This designation aims to expedite the development of drugs that show potential for substantial improvement over existing therapies. Mavacamten demonstrated a strong safety profile and significant treatment benefits in clinical trials, leading to plans for an NDA submission in early 2021. HCM is a serious condition impacting about 1 in 500 people, with no targeted therapies currently available.
MyoKardia and Fulcrum Therapeutics have formed a strategic collaboration to develop targeted therapies for genetic cardiomyopathies. MyoKardia will utilize Fulcrum's proprietary target discovery engine to identify therapeutics that address key genetic drivers. The agreement involves an upfront payment of $12.5 million, with potential milestone payments up to $302.5 million for the first product, and additional payments if more targets are pursued. MyoKardia aims to leverage its research capabilities to advance drug development and meet the needs of patients with cardiovascular diseases.
MyoKardia, Inc. (Nasdaq: MYOK) has appointed Denelle Waynick as the new General Counsel and Corporate Secretary, effective immediately. With over 25 years of experience in legal and business roles, Waynick previously served at UCB and Actavis. She succeeds Cynthia Ladd, who will retire this year after leading the legal department since January 2018. CEO Tassos Gianakakos praised Waynick for her leadership and relevant experience in advancing the company’s precision cardiovascular medicines as they approach commercialization.
MyoKardia announced positive results from its Phase 2a clinical trial of danicamtiv (formerly MYK-491) for chronic heart failure with reduced ejection fraction (HFrEF). The trial demonstrated that danicamtiv was well tolerated and led to significant improvements in left ventricular contractility and left atrial function. Specifically, the treatment resulted in notable increases in left ventricular stroke volume while maintaining diastolic function. MyoKardia plans to initiate two Phase 2 trials targeting genetic dilated cardiomyopathy and HFrEF patients with atrial fibrillation.
MyoKardia, Inc. (Nasdaq: MYOK) announced the presentation of data from its Phase 2a study of danicamtiv, a treatment for chronic heart failure with reduced ejection fraction (HFrEF), at the European Society of Cardiology's HFA Discoveries event. Scheduled for June 19, 2020, the session includes insights on danicamtiv’s mechanism of action. A conference call on June 22, 2020, will discuss study results, accessible via phone and webcast. MyoKardia specializes in precision medicine for cardiovascular diseases, aiming to innovate therapies targeting cardiac muscle contraction.
MyoKardia, a biopharmaceutical firm, has priced a public offering of 5,250,000 shares at $105.00 each, with an option for underwriters to buy an additional 787,500 shares. The offering is set to close around May 15, 2020, pending customary conditions. Proceeds will fund regulatory processes and clinical trials for its drug mavacamten, aimed at treating obstructive hypertrophic cardiomyopathy, along with other clinical studies and general corporate needs. The company emphasizes its targeted therapy approach for cardiovascular diseases.
MyoKardia, a biopharmaceutical company, announced a proposed public offering of $450 million in common stock, with a potential $67.5 million option for underwriters. Proceeds will support regulatory processes and potential launches of mavacamten for obstructive hypertrophic cardiomyopathy and ongoing studies for other treatments. The offering is subject to market conditions, with no assurance on completion or terms. Major banks are involved as joint bookrunning managers, and final terms will be disclosed in a future prospectus.
MyoKardia announced positive topline results from the Phase 3 EXPLORER-HCM trial for mavacamten, a treatment for symptomatic obstructive hypertrophic cardiomyopathy. The trial met primary and secondary endpoints with high statistical significance (p≤0.0006). Mavacamten showed significant improvements in symptoms, quality of life, and cardiac function compared to placebo. Notably, 98% of participants completed the study, indicating good tolerability. A New Drug Application is planned for early 2021, marking a crucial step in providing targeted therapy for HCM.
