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MyoKardia, Inc. (MYOK) Create: Alert

All | News | Filings
Date FiledTypeDescription
11/17/2020 8-K Resignation/termination of a director
Docs: "Amended and Restated Certificate of Incorporation of MyoKardia, Inc. (filed herewith)",
"Second Amended and Restated Bylaws of MyoKardia, Inc. (filed herewith)"
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"
10/05/2020 8-K Quarterly results
08/04/2020 8-K Quarterly results
06/24/2020 8-K Quarterly results
05/14/2020 8-K Quarterly results
05/11/2020 8-K Quarterly results
05/06/2020 8-K Quarterly results
03/30/2020 8-K Quarterly results
03/26/2020 8-K Quarterly results
02/27/2020 8-K Quarterly results
01/03/2020 8-K Quarterly results
11/12/2019 8-K Quarterly results
10/04/2019 8-K Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers: Compensatory Arrangements...
Docs: "UNITED STATES SECURITIES AND EXCHANGE COMMISSION"
09/10/2019 8-K Other Events, Financial Statements and Exhibits  Interactive Data
Docs: "UNITED STATES SECURITIES AND EXCHANGE COMMISSION",
"MyoKardia to Evaluate Mavacamten as an Alternative to Septal Reduction Therapy in Obstructive Hypertrophic Cardiomyopathy Patients"
08/07/2019 8-K Quarterly results
07/18/2019 8-K Entry into a Material Definitive Agreement, Regulation FD Disclosure, Financial Statements and Exhibits
Docs: "MyoKardia Announces HCM Program Updates: Accelerates Timing for Mavacamten Topline Phase 3 Data; Re-acquires U.S. Royalty Rights to HCM Programs from Sanofi"
06/18/2019 8-K Submission of Matters to a Vote of Security Holders
Docs: "UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15 of the Securities Exchange Act of 1934 Date of Report : June 13, 2019 MYOKARDIA, INC. Delaware 001-37609 44-5500552 333 Allerton Ave. South San Francisco, CA 94080 741-0900 Not Applicable Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions: ☐ Written communications pursuant to Rule 425 under the Securities Act ☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act ☐ Pre-commencement communications pursuant to Rule 14d-2 under the Exchange Act ) ☐ Pre-commencement communications pursuant to Rule 13e-4 under the ..."
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..."
03/28/2019 8-K Other Events, Financial Statements and Exhibits
Docs: "Underwriting Agreement, by and among MyoKardia, Inc. and Merrill Lynch, Pierce, Fenner & Smith Incorporated, Credit Suisse Securities (USA) LLC, Cowen & Company, LLC and Wells Fargo Securities, LLC, as representatives of the several underwriters named therein",
"Opinion of Goodwin Procter LLP",
"MyoKardia Announces Proposed Public Offering of Common Stock SOUTH SAN FRANCISCO, Calif., March 25, 2019 - MyoKardia, Inc. , a clinical-stage biopharmaceutical company pioneering a precision medicine approach for the treatment of serious cardiovascular diseases, today announced that it has commenced a proposed underwritten public offering to sell $200,000,000 in shares of its common stock. MyoKardia expects to grant the underwriters a 30-day option to purchase up to $30,000,000 in additional shares of common stock at the public offering price, less the underwriting discount. All shares of common stock will be offered by MyoKardia. MyoKardia anticipates using net proceeds from the offering, together with its existing cash, cash equivalents and short-term and long-term investments, to suppor...",
"MyoKardia Announces Pricing of Public Offering of Common Stock SOUTH SAN FRANCISCO, Calif., March 26, 2019 — MyoKardia, Inc. , a clinical-stage biopharmaceutical company pioneering a precision medicine approach for the treatment of serious cardiovascular diseases, today announced the pricing of an underwritten public offering of 4,925,000 shares of its common stock at a public offering price of $51.00 per share, before underwriting discounts. In addition, the underwriters have a 30-day option to purchase up to an additional 738,750 shares of common stock on the same terms and conditions. MyoKardia anticipates using net proceeds from the offering, together with its existing cash, cash equivalents and short-term and long-term investments, to support the ongoing registration studies, regulato..."
02/28/2019 8-K Quarterly results
01/02/2019 8-K Termination of a Material Definitive Agreement, Regulation FD Disclosure, Other Events, Financial Statements and Exhibits
Docs: "MyoKardia Regains Global Rights to Mavacamten and MYK-491 Programs from Sanofi"
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..."
09/14/2018 8-K Entry into a Material Definitive Agreement, Creation of a Direct Financial Obligation or an Obligation under an Off-Balance S...
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..."
06/15/2018 8-K Submission of Matters to a Vote of Security Holders
05/23/2018 8-K Other Events, Financial Statements and Exhibits
Docs: "Underwriting Agreement, by and among MyoKardia, Inc. and J.P. Morgan Securities LLC, Merrill Lynch, Pierce, Fenner & Smith Incorporated, Credit Suisse Securities (USA) LLC and Wells Fargo Securities, LLC, as representatives of the several underwriters named therein",
"Opinion of Goodwin Procter LLP",
"MyoKardia Announces Proposed Public Offering of Common Stock SOUTH SAN FRANCISCO, Calif., May 21, 2018 - MyoKardia, Inc. , a clinical-stage biopharmaceutical company pioneering a precision medicine approach for the treatment of heritable cardiovascular diseases, today announced that it has commenced a proposed underwritten public offering of 3,750,000 shares of its common stock. All shares of common stock will be offered by MyoKardia. In addition, MyoKardia expects to grant the underwriters a 30-day option to purchase an additional 562,500 shares of common stock at the public offering price, less the underwriting discount. MyoKardia anticipates using the net proceeds from the offering, together with its existing cash, cash equivalents and short-term and long-term investments, to fund resea...",
"MyoKardia Announces Pricing of Public Offering of Common Stock SOUTH SAN FRANCISCO, Calif., May 22, 2018 — MyoKardia, Inc. , a clinical-stage biopharmaceutical company pioneering a precision medicine approach for the treatment of heritable cardiovascular diseases, today announced the pricing of an underwritten public offering of 3,750,000 shares of its common stock at a public offering price of $49.00 per share, before underwriting discounts. In addition, the underwriters have a 30-day option to purchase an additional 562,500 shares of common stock on the same terms and conditions. MyoKardia anticipates using the net proceeds from the offering, together with its existing cash, cash equivalents and short-term and long-term investments, to fund research and development activities for its dev..."
05/21/2018 8-K Other Events
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..."
04/04/2018 8-K Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers: Compensatory Arrangements...
Docs: "Offer Letter by and between MyoKardia, Inc. and Taylor Harris",
"MyoKardia Announces Appointment of Taylor C. Harris as Chief Financial Officer SOUTH SAN FRANCISCO, Calif., April 4, 2018 - MyoKardia, Inc. , a clinical-stage biopharmaceutical company pioneering a precision medicine approach for the treatment of heritable cardiovascular diseases, today announced the appointment of Taylor C. Harris as Chief Financial Officer. Mr. Harris brings more than 20 years of finance and life science industry experience to MyoKardia and will lead the finance, accounting, information technology, facilities, corporate communications, and investor relations functions. Jake Bauer, who has been leading these functions at MyoKardia since 2014 as Senior Vice President, Finance and Corporate Development, has been promoted to the role of Chief Business Officer. In this new po..."
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..."
03/08/2018 8-K Other Events, Financial Statements and Exhibits
Docs: "MyoKardia Announces Positive Results from Low-Dose Cohort of Phase 2 PIONEER-HCM Study of Mavacamten in Symptomatic, Obstructive Hypertrophic Cardiomyopathy Patients"
03/05/2018 8-K Quarterly results
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..."
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