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MyoKardia, Inc. (MYOK) Create: Alert

All | News | Filings
Date FiledTypeDescription
11/05/2020 8-K Quarterly results
Docs: "MyoKardia Reports Third Quarter 2020 Financial Results Acquisition of MyoKardia by Bristol-Myers Squibb Expected to Close During 4th Quarter of 2020"
08/04/2020 8-K Quarterly results
05/06/2020 8-K Quarterly results
02/27/2020 8-K Quarterly results
08/07/2019 8-K Quarterly results
05/09/2019 8-K Quarterly results
Docs: "Presented 12- and 24-week data from PIONEER Open-Label Extension Study of Mavacamten in Obstructive HCM : At the American College of Cardiology 68th Annual Scientific Session in March 2019, MyoKardia presented positive twenty-four week safety and efficacy data from the PIONEER-OLE study. Mavacamten treatment improved patient symptoms as measured by NYHA classification and reduced or eliminated obstruction of the left ventricular outflow tract to levels below the guideline-based thresholds for diagnosis and for invasive intervention in all patients, without reducing left ventricular ejection fraction below normal. Mavacamten was well tolerated with no cardiac-related adverse events. These data reflect the longest duration of mavacamten treatment reported to date. o Thirty-six-week data from..."
02/28/2019 8-K Quarterly results
11/07/2018 8-K Quarterly results
Docs: "Dosed first patient in MAVA Long-Term Extension Study of Mavacamten in HCM: The MAVA-LTE study will assess long-term safety of mavacamten, as well as its effects on hypertrophic cardiomyopathy symptoms and cardiac function in patients who successfully complete either MyoKardia’s MAVERICK-HCM or EXPLORER-HCM clinical trials of mavacamten. Data from the MAVA-LTE clinical trial, along with results of the pivotal Phase 3 EXPLORER-HCM trial, are intended to support the registration submission for mavacamten for the treatment of obstructive HCM . - Reported encouraging initial data from PIONEER Open-Label Extension Study: Twelve of twenty patients with oHCM who previously completed MyoKardia’s Phase 2 PIONEER-HCM study of mavacamten for the treatment of symptomatic oHCM have enrolled in the PION..."
08/08/2018 8-K Quarterly results
Docs: "Dosed First Patient in Phase 3 EXPLORER-HCM Clinical Trial of Mavacamten in oHCM: The pivotal EXPLORER-HCM trial will enroll 220 patients with obstructive hypertrophic cardiomyopathy , randomized to receive individualized doses of mavacamten or placebo. The primary endpoint for the study will be clinical response. Clinical response can be achieved by meeting either of two definitions: 1) an improvement of at least 1.5 mL/kg/min in peak VO 2 accompanied by a reduction from baseline of at least one New York Heart Association functional class, or 2) an improvement from baseline of 3.0 mL/kg/min or greater in peak VO 2 without worsening in NYHA functional class. MyoKardia expects to report topline results from the Phase 3 trial in the second half of 2020. o A long-term extension study of patie..."
05/08/2018 8-K Quarterly results
Docs: "Phase 3 EXPLORER-HCM Trial Preparations Underway: MyoKardia remains on track to dose the first patient in the pivotal Phase 3 EXPLORER-HCM clinical trial of mavacamten for the treatment of symptomatic, obstructive hypertrophic cardiomyopathy during the second quarter of 2018. o MyoKardia plans to announce the final design of the Phase 3 EXPLORER trial in the coming weeks pending the receipt of written feedback from the U.S. Food and Drug Administration following a recent Type C meeting. o A long-term extension study of patients who complete the Phase 3 EXPLORER-HCM or the Phase 2 MAVERICK-HCM trial is expected to begin by year-end. As previously announced, this LTE study is part of the overall mavacamten registration package agreed to by the FDA. - Initiated Phase 2 MAVERICK-HCM Clinical T..."
03/08/2018 8-K Quarterly results
Docs: "Mavacamten Met Primary Endpoint and Key Secondary Endpoints of PIONEER-HCM Study in Both Study Cohorts: In the PIONEER-HCM Phase 2 clinical trial of 21 symptomatic obstructive HCM patients, mavacamten achieved the primary endpoint of reduction in post-exercise left ventricular outflow tract gradient from baseline to week 12 with statistical significance across both cohorts tested. Improvements in peak VO 2 , New York Heart Association classification and dyspnea rating scores were also observed. Mavacamten was generally well-tolerated. - Mavacamten Activity was Persistent and Safety was not Discernably Impacted by Use of Background Beta Blockers: Benefits were observed across endpoints among those taking once-daily 2mg and 5mg doses of mavacamten who remained on background beta blocker ther..."
11/02/2017 8-K Quarterly results
Docs: "End-of-Phase 2 Meeting with FDA for oHCM. In consultation with the FDA, MyoKardia has established the key elements of the registration program for mavacamten in symptomatic oHCM, including the Phase 3 EXPLORER-HCM clinical trial and a planned long-term extension study. The primary endpoint of the EXPLORER-HCM trial will be an improvement in exercise capacity as measured by the change in peak oxygen consumption from baseline. The Phase 3 clinical study is designed to enroll between 200-250 patients with symptomatic oHCM. MyoKardia expects to begin patient dosing of the Phase 3 trial in the second quarter of 2018. ▪ Lower-Dose Cohort of PIONEER-HCM Trial Enrollment Complete. In August 2017, MyoKardia announced that enrollment had completed in the second, lower-dose cohort of PIONEER-HC..."
08/07/2017 8-K Quarterly results
Docs: "Cash Position: Cash and cash equivalents as of June 30, 2017 were $117.3 million, compared to $135.8 million as of December 31, 2016. Investments as of June 30, 2017 were $48.0 million, compared to $16.1 million as December 31, 2016. ▪ Revenues: Collaboration and license revenue was $5.6 million during the three months ended June 30, 2017, compared with $3.5 million during the same period in 2016. Collaboration and license revenue was $11.3 million for the first half of 2017, compared to $7.1 million for the same period in 2016. ▪ R&D Expenses: Research and development expenses for the three months ended June 30, 2017 were $13.7 million, up from $9.3 million for the three months ended June 30, 2016. Research and development expenses were $25.6 million for the first half of 2017..."
05/09/2017 8-K Form 8-K - Current report
08/09/2016 8-K Form 8-K - Current report
05/12/2016 8-K Form 8-K - Current report
03/18/2016 8-K Form 8-K - Current report

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