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): June 21, 2011
CORMEDIX INC. | ||
| (Exact name of registrant as specified in its charter) | ||
Delaware | 001-34673 | 20-5894890 |
(State or other jurisdiction of incorporation) | (Commission File Number) | (IRS Employer Identification No.) |
745 Rt. 202-206, Suite 303, Bridgewater, NJ | 08807 | |
| (Address of principal executive offices) | (Zip Code) | |
Registrant’s telephone number, including area code: (908) 517-9500
| (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 (see General Instruction A.2. below):
o 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))
| Item 8.01. | Other Events. |
On June 21, 2011, CorMedix Inc. (the “Company”) issued a press release announcing that it has received a Special Protocol – Agreement letter from the U.S. Food and Drug Administration regarding a Special Protocol Assessment on the design of a pivotal Phase 3 trial for the Company’s oral drug candidate CRMD001, the Company’s proprietary formulation of deferiprone, in the prevention of Contrast-Induced Acute Kidney Injury. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
| Item 9.01. | Financial Statements and Exhibits. |
(d) Exhibits
| Exhibit No. | Description |
| 99.1 | Press Release, dated June 21, 2011. |
SIGNATURE
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.
| June 21, 2011 | CORMEDIX INC. | ||
| By: | /s/ Brian Lenz | ||
| Name: | Brian Lenz | ||
| Title: | Chief Financial Officer | ||
EXHIBIT INDEX
| Exhibit No. | Description |
| 99.1 | Press Release, dated June 21, 2011. |