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): September 5, 2017
IMMUNE PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
| Delaware | 001-36602 | 52-1841431 |
|
(State or other jurisdiction of incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
| 550 Sylvan Avenue, Suite 101, Englewood Cliffs, NJ | 07632 |
| (Address of principal executive offices) | (Zip Code) |
Registrant’s telephone number, including area code: (201) 464-2677
(Former name or former address, if changed since last report) N/A
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:
| ¨ | 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)) |
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 8.01 | Other Events |
Immune Pharmaceuticals, Inc. (the “Company”) is developing its lead product candidate, bertilimumab, for bullous pemphigoid (“BP”) an orphan auto-immune skin blistering disease, and ulcerative colitis, a disease that causes inflammation and ulcers in the lining of the large intestine.
As previously reported, the Company filed an application with the Office of Orphan Products Development of the Food and Drug Administration (the “FDA”) to obtain Orphan Drug Designation for bertilimumab in BP on February 24, 2017. On September 5, 2017, the Company received a letter from the FDA requesting additional clinical or preclinical data to allow the FDA to complete its review. The Company intends to provide data in response to the FDA’s request as soon as practicable.
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 thereunto duly authorized.
| IMMUNE PHARMACEUTICALS INC. | |||
| By: | /s/ Elliot M. Maza | ||
| Name: | Elliot M. Maza | ||
| Title: | Interim Chief Executive Officer | ||
| Date: September 8, 2017 | |||