Current Report Filing (8-k)
June 01 2020 - 4:01PM
Edgar (US Regulatory)
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): June 1, 2020
AVEO Pharmaceuticals, Inc.
(Exact Name of Registrant as Specified in Charter)
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Delaware
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001-34655
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04-3581650
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(State or Other Jurisdiction
of Incorporation)
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(Commission
File Number)
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(IRS Employer
Identification No.)
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30 Winter Street
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Boston, Massachusetts
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02108
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(Address of Principal Executive Offices)
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(Zip Code)
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Registrants telephone number, including area
code: (857) 400-0101
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 (see General Instruction A.2. below):
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule 14a-12 under the
Exchange Act (17 CFR 240.14a-12)
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Securities registered pursuant to Section 12(b) of the Act:
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Title of each class
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Trading Symbol(s)
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Name of each exchange on which
registered
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Common Stock, $0.001 par value
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AVEO
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Nasdaq Capital Market
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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. ☐
On June 1, 2020, AVEO Pharmaceuticals, Inc. (the Company) issued a press release announcing that the U.S. Food and Drug Administration (the
FDA) accepted for filing the Companys New Drug Application (the NDA), which seeks approval for tivozanib as a treatment for relapsed or refractory renal cell carcinoma. The FDA assigned the NDA standard review and a
Prescription Drug User Fee Act target action date of March 31, 2021. The FDA also indicated that they do not currently plan on convening an Oncologic Drug Advisory Committee to discuss the NDA.
The full text of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K.
Item 9.01.
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Financial Statements and Exhibits.
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(d) Exhibits
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.
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AVEO Pharmaceuticals, Inc.
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Date: June 1, 2020
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By:
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/s/ Michael Bailey
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Michael Bailey
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President and Chief Executive Officer
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