Inovio Pharmaceuticals Inc. filed SEC Form 8-K: Other Events, Regulation FD Disclosure
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| Item 7.01 | Regulation FD Disclosure. |
As described in Item 8.01 below, on December 29, 2025, Inovio Pharmaceuticals, Inc. (the “Company”) issued a press release announcing that the U.S. Food and Drug Administration (the “FDA”) has accepted the Company’s Biologic License Application (“BLA”) for INO-3107, an investigational immunotherapy for the treatment of recurrent respiratory papillomatosis (“RRP”) in adults. The press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference. The information contained in this Item 7.01, as well as the press release furnished as Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liability of that section, nor shall it be deemed incorporated by reference into any of the Company’s filings under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, regardless of any incorporation language in such a filing, except as expressly set forth by specific reference in such a filing.
| Item 8.01 | Other Events. |
On December 29, 2025, the Company announced that the FDA has accepted the Company’s BLA for INO-3107 for review as a potential treatment for adults with RRP. The review classification designated by the FDA is Standard. The FDA assigned INO-3107 a Prescription Drug User Fee Act (PDUFA) review goal date of October 30, 2026, which is the date by which it intends to take action on the application. The FDA has indicated that it is not currently planning to hold an advisory committee meeting to discuss this application. The Company filed the BLA under the accelerated approval pathway. In the file acceptance letter, the FDA noted as a potential review issue its preliminary conclusion that the Company has not submitted adequate information to justify eligibility for the accelerated approval pathway. The Company plans to request a meeting with FDA to discuss next steps to remain eligible under the accelerated approval program. The Company is not currently planning to seek approval for INO-3107 under the traditional pathway.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits
| Exhibit Number |
||
| 99.1 | Press Release, dated December 29, 2025, “FDA Accepts for Review INOVIO’s BLA for INO-3107 for the Treatment of Adults with Recurrent Respiratory Papillomatosis (RRP).” | |
| 104 | Cover Page Interactive Data File (formatted as inline XBRL). | |
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.
| INOVIO PHARMACEUTICALS, INC. | ||||||
| Date: December 29, 2025 | By: | /s/ Peter Kies | ||||
| Peter Kies | ||||||
| Chief Financial Officer | ||||||