MyoKardia is developing mavacamten for the treatment of HCM. Mavacamten was specifically developed to correct the abnormal mechanics of the HCM heart by normalizing the number of myosin-actin cross-bridges that drive the excessive contractility, left ventricular hypertrophy and reduced compliance characteristic of HCM.

MyoKardia’s Phase 2 MAVERICK-HCM study of mavacamten was the first study to examine quantitative levels of activity in a non-obstructive HCM patient population. As part of the MAVERICK-HCM study, patients were asked to wear ActiGraph GT9X Link wrist-worn monitors for up to 14 days between screening and day 1 and between weeks 12 and 16 to record daily activity.

Bristol Myers Squibb Completes Acquisition of MyoKardia, Strengthening Company’s Leading Cardiovascular Franchise. November 17, 2020 MyoKardia Presents Cardiac Imaging Data from 30-Week EXPLORER-HCM Study of Mavacamten. November 15, 2020 2021-03-19 · On top of mavacamten, BMS is developing MyoKardia’s pipeline of novel compounds, which comprises two clinical-stage therapeutics, danicamtiv and MYK-224, as well as two pre-clinical assets, ACT-1 and LUS-1. The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date for a decision on mavacamten in oHCM on 28 January 2022. MyoKardia’s Phase 2 MAVERICK-HCM study of mavacamten was the first study to examine quantitative levels of activity in a non-obstructive HCM patient population. As part of the MAVERICK-HCM study, patients were asked to wear ActiGraph GT9X Link wrist-worn monitors for up to 14 days between screening and day 1 and between weeks 12 and 16 to record daily activity.

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MyoKardia’s mission is to change the world for people with serious cardiovascular disease through bold and innovative science. Bristol Myers Squibb to Acquire MyoKardia for $13.1 Billion in Cash Mavacamten Is a Potential First-in-Class Medicine with Compelling Data in the Treatment of Patients with Symptomatic Obstructive Hypertrophic Cardiomyopathy Mavacamten Will Be a Medium- and Long-Term Growth Driver Presenting a Significant Commercial Opportunity upon Approval MyoKardia is developing mavacamten for the treatment of conditions in which excessive cardiac contractility and impaired diastolic filling of the heart are the underlying cause. Mavacamten is Analyst Says Mavacamten Worth $3B: Myokardia is focused on developing precision medicines for genetic heart disease, with its lead myosin modulator mavacamten awaiting regulatory filing in MyoKardia is developing mavacamten for the treatment of conditions in which excessive cardiac contractility and impaired diastolic filling of the heart are the underlying cause. Mavacamten is initially being developed for the treatment of symptomatic, obstructive hypertrophic cardiomyopathy (HCM). Through the transaction with MyoKardia, Bristol Myers Squibb gains mavacamten, a potential first-in-class cardiovascular medicine for the treatment of obstructive hypertrophic cardiomyopathy (“HCM”), a chronic heart disease with high morbidity and patient impact. Mavacamten, formerly known as MYK-461 is a recently discovered novel small-molecule modulator of cardiac myosin that targets the underlying sarcomere hypercontractility of hypertrophic cardiomyopathy, one of the most prevalent heritable cardiovascular disorders.

Bristol Myers Squibb Completes Acquisition of MyoKardia, Strengthening Company’s Leading Cardiovascular Franchise. November 17, 2020 MyoKardia Presents Cardiac Imaging Data from 30-Week EXPLORER-HCM Study of Mavacamten. November 15, 2020

Mavacamten is Analyst Says Mavacamten Worth $3B: Myokardia is focused on developing precision medicines for genetic heart disease, with its lead myosin modulator mavacamten awaiting regulatory filing in MyoKardia is developing mavacamten for the treatment of conditions in which excessive cardiac contractility and impaired diastolic filling of the heart are the underlying cause. Mavacamten is initially being developed for the treatment of symptomatic, obstructive hypertrophic cardiomyopathy (HCM). Through the transaction with MyoKardia, Bristol Myers Squibb gains mavacamten, a potential first-in-class cardiovascular medicine for the treatment of obstructive hypertrophic cardiomyopathy (“HCM”), a chronic heart disease with high morbidity and patient impact. Mavacamten, formerly known as MYK-461 is a recently discovered novel small-molecule modulator of cardiac myosin that targets the underlying sarcomere hypercontractility of hypertrophic cardiomyopathy, one of the most prevalent heritable cardiovascular disorders.

Bristol Myers Squibb to Acquire MyoKardia for $13.1 Billion in Cash Mavacamten Is a Potential First-in-Class Medicine with Compelling Data in the Treatment of Patients with Symptomatic Obstructive Hypertrophic Cardiomyopathy Mavacamten Will Be a Medium- and Long-Term Growth Driver Presenting a Significant Commercial Opportunity upon Approval

The company recently regained rights to the drug from ex-partner Sanofi, and is 2020-07-24 · MyoKardia announced that the FDA has granted breakthrough therapy designation to mavacamten for the treatment of patients with symptomatic, obstructive hypertrophic cardiomyopathy.Mavacamten is a MyoKardia is currently preparing a New Drug Application (NDA) for mavacamten, with plans to submit to the FDA in the first quarter of 2021. About HCM Hypertrophic cardiomyopathy (HCM) is a chronic, progressive disease in which excessive contraction of the heart muscle and reduced ability of the left ventricle to fill can lead to the development of debilitating symptoms and cardiac dysfunction. MyoKardia’s Phase 2 MAVERICK-HCM study of mavacamten was the first study to examine quantitative levels of activity in a non-obstructive HCM patient population.

As part of the MAVERICK-HCM study, patients were asked to wear ActiGraph GT9X Link wrist-worn monitors for up to 14 days between screening and day 1 and between weeks 12 and 16 to record daily activity. At the same time, mavacamten was generally well tolerated, with similar rates of serious side effects. MyoKardia said the Explorer-HCM data will form the basis of its submission to the FDA, slated RELATED: ESC: MyoKardia's mavacamten boosts heart function in phase 3, teeing up 2021 filing With an estimated $2 billion in 2026 worldwide sales, mavacamten ranks third on EvaluatePharma’s Analyst Says Mavacamten Worth $3B: Myokardia is focused on developing precision medicines for genetic heart disease, with its lead myosin modulator mavacamten awaiting regulatory filing in Following the positive results, California-based MyoKardia said it is eying early 2021 to file its first New Drug Application for mavacamten, an allosteric modulator of cardiac myosin. In the Phase III EXPLORER-HCM clinical trial, mavacamten demonstrated a robust treatment effect and met all primary and secondary endpoints.
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MyoKardia plans to submit a New Drug Application for mavacamten to the U.S. Food and Drug Administration (FDA) in the first quarter of 2021. About EXPLORER-HCM The EXPLORER-HCM Phase 3 trial enrolled a total of 251 patients with symptomatic (NYHA Class II or III), obstructive hypertrophic cardiomyopathy. About Mavacamten (MYK-461) MyoKardia is developing mavacamten, a first-in-class, oral, allosteric modulator of cardiac myosin, for the treatment of conditions in which excessive cardiac contractility and impaired diastolic filling of the heart are the underlying cause.

2020-08-30 · According to Florence, Italy’s Dr. Iacopo Olivotto, who presented the results to ESC’s virtual audience, mavacamten was generally well tolerated and did not appear to have serious side effects. MyoKardia said the Explorer-HCM data will form the basis of its submission to the FDA which is planned for the first quarter of 2021. --MyoKardia, Inc. today announced that the U.S. Food and Drug Administration has granted Breakthrough Therapy Designation to mavacamten, a novel, oral, allosteric modulator of cardiac myosin, for MyoKardia also shared its analyses of the effect of mavacamten treatment on two subgroups of patients with advanced disease: one comprising 19 of the 59 enrolled patients (32%) with elevated 2020-11-02 · BRISBANE, Calif., Nov. 02, 2020 (GLOBE NEWSWIRE) -- MyoKardia, Inc. (Nasdaq: MYOK) today announced the upcoming presentation of clinical and non-clinical data related to mavacamten, MyoKardia’s 2020-11-05 · EXPLORER-HCM Data Presented at the European Society of Cardiology 2020 Virtual Congress and Published in The Lancet: Results from MyoKardia’s Phase 3 clinical study of mavacamten for the 2020-05-11 · MyoKardia said patients tolerated its drug comparatively well. Between 8% and 9% of patients in both the mavacamten and placebo groups experienced serious adverse events.
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2020-10-05 · Bristol Myers is paying $225 per share for MyoKardia, a roughly 61% premium to the biotech's $139.60 closing price on Friday. The acquisition gives the larger drugmaker rights to mavacamten, a treatment for a chronic heart condition known as obstructive hypertrophic cardiomyopathy that could be headed for a regulatory review by next year.

As part of the MAVERICK-HCM study, patients were asked to wear ActiGraph GT9X Link wrist-worn monitors for up to 14 days between screening and day 1 and between weeks 12 and 16 to record daily activity. 2020-08-03 Bristol Myers Squibb expects to explore the full potential of mavacamten in additional indications, including non-obstructive HCM, as well as develop MyoKardia’s promising pipeline of novel compounds, including two clinical-stage therapeutics: danicamtiv (formerly MYK-491) and MYK-224. Through the transaction with MyoKardia, Bristol Myers Squibb gains mavacamten, a potential first-in-class cardiovascular medicine for the treatment of obstructive hypertrophic cardiomyopathy (“HCM”), a chronic heart disease with high morbidity and patient impact. Among its discoveries are three clinical-stage therapeutics: mavacamten (formerly MYK-461); danicamtiv (formerly MYK-491) and MYK-224.

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Studies on isolated cells and muscle …. Mavacamten, formerly known as MYK-461 is a 2020-10-07 · Consensus sales estimates for mavacamten as a treatment for the underserved HCM community suggest Bristol Myers Squibb shareholders can expect annual sales of the drug to reach $1.9 billion in 2026. Bristol Myers Squibb Completes Acquisition of MyoKardia, Strengthening Company’s Leading Cardiovascular Franchise. November 17, 2020 MyoKardia Presents Cardiac Imaging Data from 30-Week EXPLORER-HCM Study of Mavacamten. November 15, 2020 2021-03-19 · On top of mavacamten, BMS is developing MyoKardia’s pipeline of novel compounds, which comprises two clinical-stage therapeutics, danicamtiv and MYK-224, as well as two pre-clinical assets, ACT-1 and LUS-1. The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date for a decision on mavacamten in oHCM on 28 January 2022.