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): December 20, 2021
CARA THERAPEUTICS, INC.
(Exact name of registrant as specified in its charter)
| Delaware | | 001-36279 | | 75-3175693 |
(State or other jurisdiction of incorporation) | | (Commission File Number) | | (IRS Employer Identification No.) |
| | | | | |
4 Stamford Plaza 107 Elm Street, 9th Floor Stamford, Connecticut | | | | 06902 |
| (Address of principal executive offices) | | | | (Zip Code) |
| | | | | |
| Registrant's telephone number, including area code: (203) 406-3700 |
| | | | | |
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.):
| ¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
| Common stock, par value $0.001 per share | CARA | The Nasdaq Stock Market LLC |
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 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
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
