UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 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 21, 2015
HISTOGENICS CORPORATION
(Exact Name of Registrant as Specified in its Charter)
| | | | |
| Delaware | | 001-36751 | | 04-3522315 |
(State or Other Jurisdiction of Incorporation) | | (Commission File Number) | | (I.R.S. Employer Identification Number) |
830 Winter Street, 3rd Floor
Waltham, Massachusetts 02451
(781) 547-7900
(Addresses, including zip code, and telephone numbers, including area code, of principal executive offices)
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):
| ¨ | 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)) |
On December 21, 2015, Histogenics Corporation (“Histogenics”) issued a press release regarding the announcement of a protocol amendment to its Phase 3 clinical trial of NeoCart®, an investigational cartilage replacement for damage in the knee. The U.S. Food and Drug Administration has agreed to the amendment under the existing Special Protocol Agreement (SPA) between it and Histogenics.
The press release is attached as Exhibit 99.1 to this Current Report on Form 8-K.
| Item 9.01. | Financial Statements and Exhibits. |
| | |
Exhibit
No. | | Description |
| |
| 99.1 | | Press Release of Histogenics Corporation dated December 21, 2015. |
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.
| | | | | | |
| | | | HISTOGENICS CORPORATION |
| | | |
| Date: December 21, 2015 | | | | By: | | /s/ Adam Gridley |
| | | | | | Adam Gridley |
| | | | | | President and Chief Executive Officer |
EXHIBIT INDEX
| | |
Exhibit
No. | | Description |
| |
| 99.1 | | Press Release of Histogenics Corporation dated December 21, 2015. |
