VALOR-HCM Designed to Generate Direct Evidence of Improved Outcomes for People with HCM by Reducing the Need for Invasive Septal Reduction Therapy BRISBANE, Calif., Aug. 03, 2020 (GLOBE NEWSWIRE) — In a release issued under the same headline on Monday, August 3rd by MyoKardia, Inc. (Nasdaq: MYOK), please note that the second quote by Jeffrey B. Geske, M.D. has changed. The […]
Tag: Myokardia
MyoKardia Announces Receipt of Breakthrough Therapy Designation from FDA for Mavacamten for the Treatment of Symptomatic, Obstructive Hypertrophic Cardiomyopathy
BRISBANE, Calif., July 23, 2020 (GLOBE NEWSWIRE) — MyoKardia, Inc. (Nasdaq: MYOK) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to mavacamten, a novel, oral, allosteric modulator of cardiac myosin, for the treatment of symptomatic, obstructive hypertrophic cardiomyopathy (HCM). The FDA’s Breakthrough Therapy Designation is intended to expedite […]
MyoKardia and Fulcrum Therapeutics Announce Multi-Target Collaboration to Discover Novel Targeted Therapies for Genetic Cardiomyopathies
Collaboration will Combine MyoKardia’s Leading Precision Cardiovascular R&D Platform with Fulcrum’s Proprietary Product Engine to Identify Targets that Modulate Gene Expression BRISBANE, Calif. and CAMBRIDGE, Mass., July 21, 2020 (GLOBE NEWSWIRE) — MyoKardia, Inc. (Nasdaq: MYOK), a clinical-stage biopharmaceutical company discovering and developing targeted therapies for the treatment of serious cardiovascular diseases and Fulcrum Therapeutics, […]
MyoKardia Announces Appointment of Denelle J. Waynick as General Counsel and Corporate Secretary
BRISBANE, Calif., July 06, 2020 (GLOBE NEWSWIRE) — MyoKardia, Inc. (Nasdaq: MYOK) today announced the appointment of Denelle Waynick as General Counsel and Corporate Secretary. Ms. Waynick joins MyoKardia from UCB, Inc., bringing more than 25 years of domestic and international legal and business expertise in the healthcare and life-science industry. Cynthia Ladd, who has […]
MyoKardia Announces Positive Data from Phase 2a Clinical Trial of Danicamtiv Presented at ESC’s HFA Discoveries with Simultaneous Publication in European Journal of Heart Failure
Danicamtiv was Well Tolerated; Demonstrated Improvements in Cardiac Contractility and Preserved Diastolic Function in Patients with Stable Heart Failure with Reduced Ejection Fraction New Observations Show Improvements in Left Atrial Volume and Function, Key Prognostic Indicators of Atrial Fibrillation Additional Nonclinical Studies Also Presented Demonstrating Danicamtiv’s Differentiated Mechanistic Profile Including Direct Activation of the Left Atrium […]
MyoKardia Announces Primary and All Secondary Endpoints Met in Phase 3 EXPLORER Clinical Trial of Mavacamten for the Treatment of Obstructive Hypertrophic Cardiomyopathy
Highly Statistically Significant Improvements in NYHA Classification, Peak VO2, and LVOT Gradient Observed vs. Placebo Mavacamten Well Tolerated; Safety Results Comparable to Placebo U.S. Regulatory Submission Planned for Early 2021 MyoKardia to Host Conference Call at 8:00 a.m. ET BRISBANE, Calif., May 11, 2020 (GLOBE NEWSWIRE) — MyoKardia, Inc. (Nasdaq: MYOK) today announced positive topline data […]
MyoKardia Announces Proposed Public Offering of Common Stock
BRISBANE, Calif., May 11, 2020 (GLOBE NEWSWIRE) — MyoKardia, Inc. (Nasdaq: MYOK), a clinical-stage biopharmaceutical company discovering and developing targeted therapies for the treatment of serious cardiovascular diseases, today announced that it has commenced a proposed underwritten public offering to sell $450.0 million in shares of its common stock. MyoKardia expects to grant the underwriters […]
MyoKardia Reports First Quarter 2020 Financial Results
BRISBANE, Calif., May 06, 2020 (GLOBE NEWSWIRE) — MyoKardia, Inc. (Nasdaq: MYOK), today reported financial results for the first quarter ended March 31, 2020. “Our team has continued to drive toward our mission, despite the extraordinary personal and professional disruptions introduced by the COVID-19 pandemic. The progress made has been exciting and inspiring, and I […]
MyoKardia Announces Mavacamten Treatment Well Tolerated and Significantly Reduced Biomarkers of Cardiac Injury and Wall Stress in Non-Obstructive Hypertrophic Cardiomyopathy Patients
MAVERICK-HCM Phase 2 Clinical Trial Results Consistent with Tolerability Observations from Prior Studies of Mavacamten Improvement in NT-proBNP and Troponin Levels Support Future Development in Non-Obstructive HCM and Heart Failure with Preserved Ejection Fraction (HFpEF) MyoKardia to Host Webcast Conference Call at 4:30 p.m. EDT BRISBANE, Calif., March 30, 2020 (GLOBE NEWSWIRE) — MyoKardia, Inc. […]
MyoKardia Provides Clinical Trial Update in the Context of the COVID-19 Pandemic
Reaffirms Second Quarter 2020 Expected Timing for Topline Data from Phase 3 EXPLORER-HCM Clinical Trial of Mavacamten and Phase 2a Danicamtiv Study BRISBANE, Calif., March 26, 2020 (GLOBE NEWSWIRE) — MyoKardia, Inc. (Nasdaq: MYOK) today provided an update to the status of its clinical programs in the context of the COVID-19 (coronavirus) pandemic given the impact […]