Tag: Bristol-Myers Squibb

U.S. Food and Drug Administration Approves Camzyos™ (mavacamten) for the Treatment of Adults With Symptomatic New York Heart Association Class II-III Obstructive Hypertrophic Cardiomyopathy (HCM) to Improve Functional Capacity and Symptoms

Camzyos is the first and only FDA-approved cardiac myosin inhibitor that specifically targets the source of obstructive HCM Approval based on groundbreaking Phase 3 EXPLORER-HCM trial demonstrating benefit in patients receiving Camzyos versus placebo PRINCETON, N.J.–(BUSINESS WIRE)–Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) […]

Bristol Myers Squibb Announces Data from EXPLORER-LTE Demonstrating Sustained Improvements in Clinically Meaningful Cardiovascular Outcomes at Weeks 48 and 84 in Patients with Symptomatic Obstructive Hypertrophic Cardiomyopathy Receiving Mavacamten

Treatment with mavacamten showed sustained improvement in left ventricular outflow tract (LVOT) gradients, New York Heart Association (NYHA) Class and N-terminal pro brain natriuretic peptide (NT-proBNP) levels At 48 and 84 Weeks, Mavacamten safety was consistent with that seen in the EXPLORER-HCM study Interim results were presented as a late-breaking […]

Bristol Myers Squibb Announces New PDUFA Date for Mavacamten

PRINCETON, N.J.–(BUSINESS WIRE)–Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has extended the review of the New Drug Application (NDA) for mavacamten for the treatment of patients with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) to April 28, 2022. The FDA notified Bristol Myers Squibb on […]

Bristol Myers Squibb Launches Could It Be HCM? Campaign to Increase Awareness of Hypertrophic Cardiomyopathy (HCM), the Most Common Inherited Heart Disease

The reported prevalence of HCM ranges from 1 in 200* to 1 in 500† people in the general population, however it is estimated that many patients remain undiagnosed, underscoring need for increased awareness and education Jared Butler, professional basketball player living with HCM, to partner on education campaign and share his […]

Bristol Myers Squibb Reports Third Quarter Financial Results for 2021

Reports Third Quarter Revenues of $11.6 Billion, an Increase of 10% YoY Posts Third Quarter Earnings Per Share of $0.69 and Non-GAAP EPS of $2.00 Advances Product Pipeline with Significant Regulatory and Clinical Milestones Achieves FDA Priority Review for Third Distinct Checkpoint Inhibitor, Relatlimab and Nivolumab Fixed-Dose Combination, as Treatment for […]

Bristol Myers Squibb Presents Late-Breaking Phase 3 Data Demonstrating Health Status Benefits of Mavacamten in Patients with Obstructive Hypertrophic Cardiomyopathy at American College of Cardiology’s 70th Annual Scientific Session

Mavacamten, a potential first-in-class cardiac myosin inhibitor for patients with symptomatic obstructive hypertrophic cardiomyopathy (oHCM), showed improvement in health status compared to placebo at 30 weeks in EXPLORER-HCM trial Findings of new analysis published simultaneously in The Lancet PRINCETON, N.J.–(BUSINESS WIRE)–Bristol Myers Squibb (NYSE: BMY) today announced a new analysis of data […]

U.S. Food and Drug Administration (FDA) Accepts Bristol Myers Squibb’s Application for Mavacamten in Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM)

U.S. FDA has assigned a target action date of January 28, 2022 Application based on results from the Phase 3 EXPLORER-HCM trial PRINCETON, N.J.–(BUSINESS WIRE)–Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for mavacamten, an investigational, novel, […]

Bristol Myers Squibb Completes Acquisition of MyoKardia, Strengthening Company’s Leading Cardiovascular Franchise

NEW YORK–(BUSINESS WIRE)–Bristol Myers Squibb (NYSE:BMY) announced today that it has successfully completed its acquisition of MyoKardia, Inc. in an all cash transaction for approximately $13.1 billion. With the completion of the acquisition, MyoKardia shares have ceased trading on the NASDAQ Global Select Market and MyoKardia is now a wholly-owned subsidiary […]