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, 2018
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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01803 |
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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: (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)) |
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 May 3, 2018, the Centers for Medicare and Medicaid Services (CMS) included ZILRETTA® (triamcinolone acetonide extended-release injectable suspension) on its list of products that have been recommended for a dedicated Healthcare Common Procedure Coding System (HCPCS) J code, effective January 1, 2019.
In March, CMS issued a product-specific C code for ZILRETTA (C9469) for Medicare claims in the hospital outpatient setting, which became effective April 1, 2018. In addition, on April 2, CMS issued a product-specific Q code for ZILRETTA (Q9993), which takes effect July 1, 2018. Q9993 will serve as a temporary universal code covering Medicare claims for ZILRETTA in all settings until a permanent J code is in place.
Flexion Therapeutics, Inc. issued a press release announcing the recommendation on May 4, 2018. A copy of the press release is attached hereto as Exhibit 99.1.
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Item 9.01 |
Financial Statements and Exhibits. |
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(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 of Flexion Therapeutics, Inc. dated May 4, 2018. |
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 4, 2018 |
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By: |
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/s/ Mark S. Levine |
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Mark S. Levine General Counsel and Corporate Secretary |