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 26, 2014 |
| NAVIDEA BIOPHARMACEUTICALS, INC. |
| (Exact name of registrant as specified in its charter) |
| Delaware | 001-35076 | 31-1080091 |
| (State or other jurisdiction | (Commission | (IRS Employer |
| of incorporation) | File Number) | Identification No.) |
| 5600 Blazer Parkway, Suite 200, Dublin, Ohio | 43017 |
| (Address of principal executive offices) | (Zip Code) |
| Registrant's telephone number, including area code | (614) 793-7500 |
(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):
| ¨ | 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 September 26, 2014, Navidea Biopharmaceuticals, Inc. (the “Company”) issued a press release announcing that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended approval of Lymphoseek® for use in sentinel node detection for melanoma, breast, and certain head and neck cancers. A copy of the Company’s September 26, 2014, press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
| Item 9.01 | Financial Statements and Exhibits. |
| (d) | Exhibits. |
| Exhibit | |
| Number | Exhibit Description |
| 99.1 | Navidea Biopharmaceuticals, Inc. press release dated September 26, 2014, entitled “Navidea’s Lymphoseek® Recommended by CHMP for European Approval in Sentinel Lymph Node Detection for Melanoma, Breast, and Certain Head and Neck Cancers.” |
Statements contained or incorporated by reference in this Current Report on Form 8-K which relate to other than strictly historical facts, such as statements about the Company’s plans and strategies, expectations for future financial performance, new and existing products and technologies, and markets for the Company’s products, are forward-looking statements. The words “believe,” “expect,” “anticipate,” “estimate,” “project,” and similar expressions identify forward-looking statements that speak only as of the date hereof. Investors are cautioned that such statements involve risks and uncertainties that could cause actual results to differ materially from historical or anticipated results due to many factors including, but not limited to, the Company’s continuing operating losses, uncertainty of market acceptance, reliance on third party manufacturers, accumulated deficit, future capital needs, uncertainty of capital funding, dependence on limited product line and distribution channels, competition, limited marketing and manufacturing experience, and other risks detailed in the Company’s most recent Annual Report on Form 10-K and other filings with the United States Securities and Exchange Commission. The Company undertakes no obligation to publicly update or revise any forward-looking statements.
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.
| Navidea Biopharmaceuticals, Inc. | |||
| Date: October 1, 2014 | By: | /s/ Brent L. Larson | |
|
Brent L. Larson, Executive Vice President and Chief Financial Officer | |||