Form 8-K NORTHWEST BIOTHERAPEUTIC For: Jul 17
UNITED STATES
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CURRENT REPORT
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| Item 7.01. | Regulation FD Disclosure. |
The Company has received a number of inquiries about rumors that are circulating alleging that the Medicines and Healthcare Products Regulatory Agency (MHRA) has made a decision on the Company’s Marketing Authorization Application (MAA) for DCVax-L for glioblastoma (GBM) and has rejected the MAA.
While the Company’s policy of not making interim reports on the MHRA process remains in place, to address these false rumors this morning the Company requested confirmation from MHRA of the current status of the MAA. This afternoon, the MHRA confirmed the following:
“The Marketing Authorisation Application submitted by Northwest Biotherapeutics, Inc. for DCVax-L (for glioblastoma) remains under its initial regulatory review, has not been refused, withdrawn or appealed, and continues to progress towards a first regulatory decision.”
The Company continues to have constructive interactions with the MHRA, and the MAA remains under review.
The Company categorically refutes the false rumors. The Company notes that such rumors appear to have intensified in the weeks since the Company presented at the British Neuro-Oncology Society (BNOS) Annual Meeting significant statistical data relating to the results of its Phase 3 trial of DCVax-L for GBM. The Company believes that the rumors appear to be accompanied by various forms stock manipulation. The Company also believes that the rumors may be part of such manipulation as the data in the BNOS presentation were quite encouraging. The Company believes it has seen this pattern on a number of occasions following positive developments and news.
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.
| NORTHWEST BIOTHERAPEUTICS, INC. | ||
| Date: July 17, 2026 | By: | /s/ Linda Powers |
| Name: | Linda Powers | |
| Title: | Chief Executive Officer and Chairman | |
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