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  • 8-K Filing

Sarepta Therapeutics (SRPT) 8-KResults suggest a highly potent next-generation treatment that could offer greater efficacy with less frequent dosing

Filed: 3 May 21, 8:52am
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    • 8-K Current report
    • 99.1 Additional exhibits
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    UNITED STATES

    SECURITIES AND EXCHANGE COMMISSION

    WASHINGTON, D.C. 20549

     

    FORM 8-K

     

    CURRENT REPORT

    Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

    Date of Report (Date of earliest event reported): May 3, 2021

     

    Sarepta Therapeutics, Inc.

    (Exact name of Registrant as Specified in Its Charter)

     

     

    Delaware

    001-14895

    93-0797222

    (State or Other Jurisdiction

    of Incorporation)

    (Commission File Number)

    (IRS Employer

    Identification No.)

     

     

     

    215 First Street
    Suite 415

    Cambridge, MA 02142

    (Address of principal executive offices, including zip code)

    Registrant’s Telephone Number, Including Area Code: (617) 274-4000

    Not Applicable

    (Former Name or Former Address, if Changed Since Last Report)

     

    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 (17 CFR 230.425)

    ☐

    Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

    ☐

    Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

    ☐

    Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

    Securities registered pursuant to Section 12(b) of the Act:

     

    Title of each class

     

    Trading

    Symbol(s)

     

    Name of each exchange on which registered

    Common Stock, Par Value $0.0001 per share

     

    SRPT

     

    The Nasdaq Global Market

    Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

    Emerging growth company ☐

    If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

     

     

     

     


     

    Item 7.01.

    Regulation FD Disclosure.

     

    On May 3, 2021, Sarepta Therapeutics, Inc. (the “Company”) issued a press release and conducted an investor webcast presenting clinical results from Phase 2 MOMENTUM study of SRP-5051 in patients with Duchenne muscular dystrophy who are amenable to exon 51 skipping. Copies of the press release and the presentation are being furnished as Exhibits 99.1 and 99.2, respectively.

     

    The information in this report, furnished pursuant to Item 7.01, including Exhibits 99.1 and 99.2 attached hereto, shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section. It may only be incorporated by reference in another filing under the Exchange Act or the Securities Act of 1933, as amended, if such subsequent filing specifically references the information furnished pursuant to Item 7.01 of this report.

     

    Item 9.01.

    Financial Statements and Exhibits.

    (d) Exhibits

     

    Exhibit No.

     

    Description

    99.1

     

    Press Release dated May 3, 2021: Sarepta Therapeutics Reports Positive Clinical Results from Phase 2 MOMENTUM Study of SRP-5051 in Patients with Duchenne Muscular Dystrophy Amenable to Skipping Exon 51

    99.2

     

    Presentation dated May 3, 2021: Clinical Update: MOMENTUM Multiple- Ascending Dose Study of SRP-5051 for Duchenne Muscular Dystrophy

    104

     

    The cover page from this Current Report on Form 8-K of Sarepta Therapeutics, Inc., formatted in Inline XBRL and included as Exhibit 101

     

    2


     

    SIGNATURES

    Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

     

     

     

    Sarepta Therapeutics, Inc.

     

     

     

     

    Date: May 3, 2021

     

    By:

    /s/ Douglas S. Ingram

     

     

     

    Douglas S. Ingram

     

     

     

    President and Chief Executive Officer

     

    3

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