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  • 8-K Filing

Athenex (ATNX) 8-KAthenex Provides Update from FDA Type A Meeting Regarding Oral Paclitaxel + Encequidar in Metastatic Breast Cancer

Filed: 12 Oct 21, 6:31am
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    SEC
    • 8-K Current report
    • 99.1 Athenex Provides Update from FDA Type A Meeting Regarding Oral Paclitaxel + Encequidar in Metastatic Breast Cancer
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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): October 11, 2021

     

     

    ATHENEX, INC.

    (Exact name of registrant as specified in its charter)

     

     

     

    Delaware 001-38112 43-1985966

    (State or other jurisdiction

    of incorporation)

     

    (Commission

    File Number)

     

    (IRS Employer

    Identification No.)

     

    1001 Main Street, Suite 600, Buffalo, New York 14203
    (Address of principal executive offices) (Zip Code)

    Registrant’s telephone number, including area code: (716) 427-2950

     

     

    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 Exchange Act:

     

    Title of each class

     

    Trading

    Symbol(s)

     

    Name of each exchange

    on which registered

    Common Stock, par value $0.001 per share ATNX The Nasdaq Global Select 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 October 11, 2021, Athenex, Inc. (the “Company”) issued a press release to announce that after holding a Type A meeting with the U.S. Food and Drug Administration regarding the New Drug Application for oral paclitaxel and encequidar (“Oral Paclitaxel”) in metastatic breast cancer, the Company has determined to redeploy its resources to focus on other ongoing studies of Oral Paclitaxel. The press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

    The information in this Item 7.01 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 or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information in this Item 7.01 is not incorporated by reference into any filing with the Securities and Exchange Commission made by the Company, whether made before or after the date hereof, regardless of any general incorporation language in the filing unless specifically stated so therein.

     

    Item 9.01

    Financial Statements and Exhibits.

    (d)    Exhibits

     

    Exhibit No.  

    Description

    99.1  Press release dated October 11, 2021
    104  Cover Page Interactive Data File (embedded within the Inline XBRL document)

     

    1


    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 hereunto duly authorized.

     

       ATHENEX, INC.
    Date: October 11, 2021   

    /s/ Steven Adams

       Name: Steven Adams
       Title: Interim Chief Accounting Officer

     

    2

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