Current Report Filing (8-k)
November 17 2020 - 8:02AM
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): November 12, 2020
Protara Therapeutics, Inc.
(Exact name of registrant as specified
in its charter)
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Delaware
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001-36694
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20-4580525
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(State or other jurisdiction
of incorporation)
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(Commission
File No.)
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(IRS Employer
Identification No.)
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1 Little West 12th Street
New York, NY
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10014
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(Address of principal executive offices)
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(Zip Code)
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Registrant’s telephone number,
including area code: (646) 844-0337
N/A
(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:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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☐
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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:
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, par value $0.001 per share
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TARA
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The 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. ☐
Item 8.01 Other Events.
On November 12, 2020, the U.S. Food and Drug Administration
Division of Vaccines and Related Products Applications (the “Division”) notified Protara Therapeutics, Inc. (the “Company”)
that an update and the accompanying clarification questions that the Company previously submitted to the Division related to the
Company’s Investigational New Drug Application for TARA-002 in Lymphatic Malformations are being reviewed and that the Division
is in the process of generating responses to the Company’s clarifying questions. The Division indicated that it will not
grant the Company’s request for an End of Phase 2 meeting at this time and that a meeting may be appropriate following the
Division’s responses to the Company’s clarifying questions.
In connection with the Division notification, on November 17,
2020, the Company made available an updated Corporate Presentation on the Investor Relations page of the Company’s website,
which will be used at investor and other meetings. A copy of the Corporate Presentation is attached hereto as Exhibit 99.1 to this
Current Report on Form 8-K and is incorporated herein by reference. The Company does not undertake to update this presentation.
Item 9.01 Financial
Statements and Exhibits.
(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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Protara Therapeutics, Inc.
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Dated: November 17, 2020
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By:
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/s/ Blaine
Davis
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Blaine Davis
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Chief Financial Officer
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