UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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Item 7.01. Regulation FD Disclosure.
On December 20, 2021, Cara Therapeutics, Inc. (the “Company”) issued a press release announcing that the U.S. Centers for Medicare & Medicaid Services (“CMS”) granted the Company’s Transition Drug Add-on Payment Adjustment (“TDAPA”) for KORSUVA™ (difelikefalin) injection (“KORSUVA injection”) in the anti-pruritic functional category.
A copy of the press release is being furnished to the Securities and Exchange Commission as Exhibit 99.1 to this Form 8-K and is incorporated by reference to this Item 7.01.
The information furnished pursuant to this Item 7.01, including Exhibit 99.1, shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed to be incorporated by reference into any of the Company’s filings with the Securities and Exchange Commission under the Exchange Act or the Securities Act of 1933, as amended, whether made before or after the date hereof, regardless of any general incorporation language in such a filing.
Item 8.01. Other Events.
On December 20, 2021, the Company announced that CMS has granted TDAPA to KORSUVA injection in the anti-pruritic functional category. TDAPA will apply to KORSUVA beginning April 4, 2022 for two years.
CMS expressed in its written communication to the Cara and Vifor Pharma, a continuing interest in engaging with the companies regarding potential post-TDAPA support to ensure all beneficiaries with end-stage renal disease have access to innovative products such as KORSUVA injection.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
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Exhibit No. |
Description | |
| 99.1 | Press Release, dated December 20, 2021. | |
| 104 | Cover page interactive data file (formatted as Inline XBRL). | |
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.
| CARA THERAPEUTICS, INC. | ||
| By: | /s/ THOMAS REILLY | |
| Thomas Reilly | ||
| Chief Financial Officer | ||
| (Principal Financial and Accounting Officer) | ||
Date: December 20, 2021