UNITED STATES
SECURITIES AND EXCHANGE COMMISSIONWashington, 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 12, 2017
Humanigen, Inc.
(Exact name of registrant as specified in its charter)
| Delaware | | 001-35798 | | 77-0557236 |
(State or other Jurisdiction of
Incorporation) | | (Commission File No.) | | (IRS Employer Identification No.) |
1000 Marina Boulevard, Suite 250
Brisbane, CA 94005-1878
(Address of principal executive offices, including zip code)
(650) 243-3100
(Registrant’s telephone number, including area code)
(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):
| ☐ | 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.
On September 12, 2017, Humanigen received a letter from the U.S. Food and Drug Administration granting Fast Track designation to the Humanigen benznidazole development program.
On August 29, 2017, as previously disclosed, FDA announced that it had granted accelerated approval of a benznidazole therapy manufactured by another company for the treatment of Chagas disease, and had awarded the other manufacturer a tropical disease priority review voucher (PRV).
As a result of FDA’s actions and with the information currently available, Humanigen, Inc. no longer expects to be eligible to receive a PRV with its own benznidazole candidate for the treatment of Chagas disease. Accordingly, Humanigen is assessing its options in respect of that development program and the company’s monoclonal antibodies, lenzilumab and ifabotuzumab.
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.
| | HUMANIGEN, INC. |
| | |
| | By: | /s/ Cameron Durrant |
| | | Name: Cameron Durrant
Title: Chairman of the Board and Chief Executive Officer |
Dated: September 15, 2017
