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 25, 2016
Flexion Therapeutics, Inc.
(Exact name of registrant as specified in its charter)
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Delaware |
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001-36287 |
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26-1388364 |
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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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10 Mall Road, Suite 301 Burlington, Massachusetts |
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(Address of principal executive offices) |
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(Zip Code) |
Registrant’s telephone number, including area code: (781) 305-7777
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligations 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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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)) |
On May 26, 2016, Flexion Therapeutics, Inc. (“Flexion”) reported that on May 25, 2016 it had received written responses from the U.S. Food & Drug Administration (“FDA”) to questions Flexion had submitted in advance of a pre-New Drug Application (“NDA”) meeting regarding its lead product candidate, Zilretta™ (also known as FX006). The FDA indicated in its responses that the safety and efficacy data from the registration program for Zilretta are acceptable to support filing of an NDA submission. Based on this positive FDA feedback, Flexion has determined to forgo the in-person pre-NDA meeting and the FDA’s written responses will serve as the official meeting minutes.
On May 26, 2016, Flexion issued a press release related to the written responses from the FDA. A copy of the press release is attached as Exhibit 99.1 hereto.
(d) Exhibits.
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Exhibit No. |
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Description |
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99.1 |
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Press Release dated May 26, 2016. |
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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Flexion Therapeutics, Inc. |
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Dated: May 26, 2016 |
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By: |
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/s/ Frederick W. Driscoll |
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Frederick W. Driscoll |
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Chief Financial Officer |
INDEX TO EXHIBITS
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Exhibit No. |
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Description |
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99.1 |
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Press Release dated May 26, 2016. |