Item 8.01 Other Items.





Clinical Trial Update

On March 26, 2020, MyoKardia, Inc. (the "Company") issued a press release titled "MyoKardia Provides Clinical Trial Update in the Context of the COVID-19 Pandemic." A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

Supplemental Risk Factor

In light of recent developments relating to the COVID-19 global pandemic, the Company is supplementing the risk factors previously disclosed in Item 1A. of its Annual Report on Form 10-K for the year ended December 31, 2019, as filed with the Securities and Exchange Commission on February 27, 2020, to include the following risk factor under the heading "Risks Related to Our Business and Industry":

The outbreak of the novel strain of coronavirus, SARS-CoV-2, which causes COVID-19, could adversely impact our business.

The outbreak of the novel strain of coronavirus, SARS-CoV-2, which causes coronavirus disease 2019 (COVID-19) has evolved into a global pandemic. In response to the spread of COVID-19, we have closed our executive offices with our administrative employees continuing their work outside of our offices, and restricted on-site staff to only those required to maintain the facilities and equipment.

As a result of the COVID-19 outbreak, or similar pandemics, we have and may in the future experience disruptions that could severely impact our business, research and clinical development activities, including:





  •   delays or difficulties in enrolling patients in our clinical trials;




     •    delays or difficulties in clinical site initiation, including
          difficulties in recruiting clinical site investigators and clinical site
          staff;




     •    delays or disruptions in non-clinical studies due to the inability of our
          research and development personnel to perform their regular duties or
          unforeseen circumstances at contract research organizations and vendors
          along their supply chain;




     •    increased rates of patients withdrawing from our clinical trials
          following enrollment as a result of contracting COVID-19, being forced to
          quarantine, or not accepting home health visits;




     •    diversion of healthcare resources away from the conduct of clinical
          trials, including the diversion of hospitals serving as our clinical
          trial sites and hospital staff supporting the conduct of our clinical
          trials;




     •    interruption of key clinical trial activities, such as clinical trial
          site data monitoring and site inspections, due to limitations on travel
          imposed or recommended by federal or state governments, employers and
          others or interruption of clinical trial subject visits and study
          procedures (particularly any procedures that may be
          deemed non-essential), which may impact the integrity of subject data and
          clinical study endpoints;




     •    interruption or delays in the operations of the U.S. Food and Drug
          Administration and comparable foreign regulatory agencies, which may
          impact review, inspection and approval timelines;




     •    interruption of, or delays in receiving, supplies of our product
          candidates from our contract manufacturing organizations due to staffing
          shortages, production slowdowns or stoppages and disruptions in delivery
          systems; and




     •    limitations on employee resources that would otherwise be focused on the
          conduct of our preclinical studies and clinical trials, including because
          of sickness of employees or their families, the desire of employees to
          avoid contact with large groups of people, an increased reliance on
          working from home or mass transit disruptions.

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In addition, the trading prices for our common stock and other biopharmaceutical companies have been highly volatile as a result of the COVID-19 epidemic. As a result, we may face difficulties raising capital through equity or debt financings, or such financing transactions may be on unfavorable terms.

The COVID-19 outbreak continues to rapidly evolve, and it is unknown how long disruptions to our research, clinical development and other business operations resulting from the COVID-pandemic, including any disruptions relating to the ultimate geographic spread of the disease, the duration of the outbreak, travel restrictions and actions by businesses and governmental authorities to contain the outbreak, such as quarantines or "stay at home" orders and business closures, will continue. However, any prolonged disruption could have a material adverse impact our business, financial condition and results of operations, and we will continue to monitor the situation closely. The information in Item 2.02 of this Form 8-K (including Exhibit 99.1) shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference under the Securities Act of 1933, as amended, except as expressly set forth by specific reference in such a filing.

Item 9.01 Financial Statements and Exhibits



(d) Exhibits.



Exhibit No.                                   Description

99.1            Press Release, dated March 26, 2020
104           Cover Page Interactive Data File (embedded within the Inline XBRL document).

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