Item 7.01 Regulation FD Disclosure. On October 5, 2026, Rezolute, Inc. (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.…
Filed Oct 5, 2026Accepted Oct 5, 2026, 8:00 AM EDTCIK 1509261Accession 0001104659-26-113503
Rezolute is a late-stage ultra-rare disease company focused on treating refractory hypoglycemia caused by any form of hyperinsulinism (HI). The Company’s antibody therapy, ersodetug, has been studied in clinical trials and used in real-world cases for the treatment of refractory hypoglycemia due to a variety of causes of HI. For more information, visit www.rezolutebio.com.
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Item 7.01Item 7.01 - Regulation FD Disclosure
Item 7.01 Regulation FD Disclosure.
On
October 5, 2026, Rezolute, Inc. (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
information in this Current Report on Form 8-K, including 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 in any filing under the Securities Act of 1933, as amended, or the Exchange
Act, whether made before or after the date hereof, except as expressly set forth by specific reference in such filing to this Current
Report on Form 8-K.
The
release contains forward looking statements. Forward-looking statements, which are based on certain assumptions and describe future plans,
strategies, and expectations of the Company, are generally identified by use of words such as “anticipate,” “believe,”
“estimate,” “expect,” “intend,” “plan,” “project,” “prove,” “potential,”
“seek,” “strive,” “try,” or future or conditional verbs such as “predict,” “could,”
“may,” “likely,” “should,” “will,” “would,” or similar expressions. The Company’s
ability to predict results or the actual results of the Company’s plans or strategies is inherently uncertain. Accordingly, actual
results may differ materially from anticipated results. Readers of the poster are cautioned not to place undue reliance on these forward-looking
statements. Except as required by applicable law or regulation, the Company undertakes no obligation to update these forward-looking
statements to reflect events or circumstances that occur after the date on which such statements were made. Important factors that may
cause such a difference include any other factors discussed in the Company’s filings with the SEC, including the Risk Factors contained
in the Company’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, which are available at the SEC’s website
at www.sec.gov.
Filed exhibits (1)
EX-99.1 (by filename) tm2626976d1_ex99-1.htm
Exhibit 99.1
Rezolute
Announces FDA Recommendation to Hold a Pre-BLA
Meeting as a Precursor to Submitting a Biologics License
Application (BLA) for Congenital
Hyperinsulinism
The
Agency reiterated its commitment to addressing the unmet need for treatment
of congenital and tumor-related hyperinsulinism and to serving
these patient communities
On
track to report topline results for the Phase 3 upLIFT study in tumor HI this quarter
REDWOOD CITY, Calif., October 5,
2026 - Rezolute, Inc. (Nasdaq: RZLT) (“Rezolute” or the “Company”), a late-stage ultra-rare disease
company focused on treating refractory hypoglycemia caused by any form of hyperinsulinism (“HI”), today announced that following
a preliminary review of detailed data from the Phase 3 sunRIZE study of ersodetug for the treatment of hypoglycemia due to congenital
HI, the U.S. Food and Drug Administration (“FDA” or “Agency”) recommended a pre-BLA meeting with the Company
as a precursor to submitting a biologics license application (BLA).
As previously reported, sunRIZE,
a Phase 3, multicenter, double-blind, randomized, placebo-controlled safety and efficacy study of ersodetug for the treatment of congenital
HI, demonstra…