mavacamten

Look out BMS, Cytokinetics has its eye on mavacamten’s turf

Shares in Cytokinetics surged after it reported positive mid-stage results for CK-274, a drug for hypertrophic cardiomyopathy (HCM) that could tread on the toes of Bristol-Myers Squibb’s mavacamten – acquired as part of its $13.1 billion takeover of MyoKardia last October. In HCM, the heart muscle become thickened and in some patients can obstruct blood …

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BMS Presents Results of Mavacamten in P-III Study for Obstructive Hypertrophic Cardiomyopathy at ACC 2021

Shots: The P-III EXPLORER-HCM study involves assessing Mavacamten vs PBO in 251 patients in a ratio (1:1) with symptomatic oHCM (LVOT gradient ≥50 mmHg and NYHA Class II-III) for 30wks, followed by an 8-week washout Results: @30wks. change in KCCQ OSS in greater than PBO arm; KCCQ OSS ≥20 points (36% vs 15%); a greater …

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BMS Presents Clinical and RWE Data of Mavacamten for Obstructive Hypertrophic Cardiomyopathy at ACC 2021

Shots: The company presented new analysis data from the P-III EXPLORER-HCM trial assessing mavacamten in patients with oHCM that tested the impact of the therapy on patients’ health status i.e symptoms, function, and QoL The company unveils the interim results from MAVA-LTE, 5yrs. extension study of the EXPLORER-HCM. The study demonstrated improvement in LVOT gradients, …

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Insights+: Breakthrough Therapy Designation by the US FDA in 2020

Breakthrough Therapy (BT) Designation is an expedited review program introduced in Section 902 of the Food and Drug Safety and Innovation Act of 2012 The Breakthrough Designation is granted to the drug candidates as monotherapy or in combination with other drugs intended to treat serious or life-threatening diseases and has shown substantial improvement over available …

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BMS acquires MyoKardia, maker of drugs for cardiovascular disease, for $13.1B

The companies expect the deal to close in the fourth quarter. MyoKardia’s lead drug candidate is mavacamten, which it is developing for hypertrophic cardiomyopathy and plans to submit to the FDA in the first quarter of next year.