Exhibit 99.1

 

News Release

 

 

 

MyoKardia Reports Fourth Quarter and
Full Year 2019 Financial Results

 

Brisbane, Calif., Feb. 27, 2020

-- MyoKardia, Inc. (Nasdaq: MYOK), today reported financial results for the fourth quarter and full year ended December 31, 2019.

 

“MyoKardia achieved significant progress in 2019, advancing our pipeline and regaining global rights to our entire portfolio. There were important data readouts across our clinical programs, including one-year safety and efficacy data from our PIONEER-OLE study of mavacamten in obstructive HCM; encouraging results from our Phase 2 MAVERICK study in non-obstructive HCM pointing to mavacamten’s ability to favorably impact diastolic relaxation; positive interim data from our Phase 2a study of danicamtiv in patients enabling us to move forward in a genetic DCM population; and the initiation of our Phase 1 study of MYK-224 in HCM,” said Tassos Gianakakos, MyoKardia’s Chief Executive Officer. “These accomplishments position us for a transformational year as we look ahead to topline results from our pivotal Phase 3 EXPLORER study of mavacamten, which we expect to report in just a few months, moving us ever closer toward our goal of leadership in targeted cardiovascular therapeutic development.”

 

2020 Anticipated Milestones

Mavacamten

 

Present complete results from the Phase 2 MAVERICK-HCM clinical trial of mavacamten in patients with non-obstructive hypertrophic cardiomyopathy (HCM) at the upcoming American College of Cardiology/World Cardiology Congress joint meeting in March 2020

 

Announce topline data from the Phase 3 EXPLORER-HCM clinical trial of mavacamten for the treatment of obstructive HCM in the second quarter of 2020

 

o

Present complete results from the EXPLORER-HCM trial before year-end

 

Initiate a Phase 2 clinical trial of mavacamten in a targeted population of patients with heart failure with preserved ejection fraction (HFpEF) in the second quarter of 2020

 

Initiate VALOR-HCM, the Phase 3 study of mavacamten as a possible alternative to septal reduction therapy (SRT) in mid-2020

 

Begin late-stage study of mavacamten in non-obstructive HCM before year-end

 

o

Provide update from regulatory interactions in the first half of 2020

 

Danicamtiv (formerly MYK-491)

 

Present complete results from the Phase 2a study of danicamtiv in patients with stable heart failure

 

Initiate a Phase 2 study of danicamtiv in patients with genetic dilated cardiomyopathy (DCM) in the second quarter of 2020

 

MYK-224

 

Share results from the Phase 1 clinical trial of MYK-224 in healthy volunteers in the third quarter of 2020

 

Initiate a Phase 2 study of MYK-224 by year end

 

Recent Clinical Program Highlights

 

Mavacamten for Hypertrophic Cardiomyopathy

 

 

Presented 48-week Data from the PIONEER-OLE Study of Mavacamten: At the American Heart Association Scientific Sessions, 48-week data from the PIONEER open-label extension study of 12 patients with obstructive HCM were presented. Consistent with data reported at 12, 24 and 36 weeks, treatment with mavacamten was generally well-tolerated, and patients continue to experience sustained clinical benefit, including reductions in left ventricular outflow tract (LVOT) gradient, improvements in NYHA functional class and improvement of multiple biomarkers toward

Driven by the Heart

 

 

 

1000 Sierra Point Parkway, Brisbane, CA 94005 / 650-741-0900 / myokardia.com

 

 
The following information was filed by Myokardia Inc (MYOK) on Thursday, February 27, 2020 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-K Annual Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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