Rezolute, Inc.: updates FDA discussions on sunRIZE trial

What happened Rezolute, Inc. announced on Oct 5, 2026 that the company issued a press release to announce an update on the company’s ongoing discussions with the FDA regarding the company’s sunRIZE trial and potential next steps. The filing states that the information in this Form 8-K, including the press release, shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934.

The filing also states that the release contains forward-looking statements identified by words such as "anticipate," "believe," "expect," "may," "will," and similar expressions, and that the company undertakes no obligation to update those forward-looking statements. The filing refers readers to the risk factors in the company’s filings on Form 10-K and Form 10-Q available at the SEC website.

Key details

• Date of filing and release: Oct 5, 2026.
• Subject: an update on ongoing discussions with the FDA about the sunRIZE trial and potential next steps.
• Item reported: Item 7.01, regulation FD disclosure (public release of material information).
• The release contains forward-looking statements and the company disclaims obligation to update them.

Why it may matter This Form 8-K reports Item 7.01, regulation FD disclosure, which covers the company’s public announcement of material information—in this case, an update on discussions with the FDA about the sunRIZE trial. A filing does not show why the insider traded or why the company acted.