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FDA continues review of Rezolute's congenital HI drug data

Wed, 09 Sep 2026 07:00:37 -0400

Rezolute, Inc. (Nasdaq: RZLT) said the U.S. Food and Drug Administration is continuing to review data submitted from its Phase 3 sunRIZE study of ersodetug for congenital hyperinsulinism, with no specific timeline for feedback.

The sunRIZE study, a randomized, double-blind, placebo-controlled trial enrolling 63 participants across more than a dozen countries, did not meet its primary or key secondary endpoints when results were announced in December 2025. The study showed reductions in hypoglycemia events, but those reductions were not statistically significant compared to placebo.

Following a March 2026 Type B meeting, the FDA requested additional study data for independent review. In June

Rezolute Provides Update on FDA Review of its Phase 3 sunRIZE Study Results in Congenital Hyperinsulinism

Wed, 09 Sep 2026 07:00:00 -0400

Data from the Phase 3 sunRIZE study remains under review by FDA

The OLE Phase of the study is ongoing, with a high participation rate and several indicators of improved glycemic control, including a notable reduction in the use of background standard of care therapies

Enrollment continues in the Phase 3 upLIFT study in tumor HI and the Company remains on track to report topline results before the end of 2026

REDWOOD CITY, Calif., Sept. 09, 2026 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT) (“Rezolute” or the “Company”), a late-stage ultra-rare

Rezolute Provides Update on FDA Review of its Phase 3 sunRIZE Study Results in Congenital Hyperinsulinism

Wed, 09 Sep 2026 07:00:00 -0400

Data from the Phase 3 sunRIZE study remains under review by FDA

Enrollment continues in the Phase 3 upLIFT study in tumor HI and the Company remains on track to report topline results before the end of 2026

REDWOOD CITY, Calif., Sept. 09, 2026 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT) (“Rezolute” or the “Company”), a late-stage ultra-rare

Rezolute to Participate in Upcoming Investor Conferences

Wed, 02 Sep 2026 07:30:00 -0400

REDWOOD CITY, Calif., Sept. 02, 2026 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT) (“Rezolute” or the “Company”), a late-stage ultra-rare disease company focused on treating refractory hypoglycemia caused by a congenital or any acquired form of hyperinsulinism (HI), today announced that management will participate in the following investor conferences:

Event: Cantor Global Healthcare Conference
Date: September 9-11, 2026

Event: H.C. Wainwright 28^th Annual Global Investment Conference
Date: September 14-16, 2026

Event: Morgan Stanley 24^th Annual Global Healthcare Conference
Date: September 14-16, 2026

Management will be participating in fireside

Rezolute to Participate in Upcoming Investor Conferences

Wed, 02 Sep 2026 07:30:00 -0400

Event: Cantor Global Healthcare Conference
Date: September 9-11, 2026

Event: H.C. Wainwright 28^th Annual Global Investment Conference
Date: September 14-16, 2026

Event: Morgan Stanley 24^th Annual Global Healthcare Conference
Date: September 14-16, 2026

Management will be participating in fireside

Form SCHEDULE 13G/A Rezolute, Inc. Filed by: BALYASNY ASSET MANAGEMENT L.P.

Fri, 14 Aug 2026 06:10:00 -0400

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Form SCHEDULE 13G/A Rezolute, Inc. Filed by: BALYASNY ASSET MANAGEMENT L.P.

Fri, 14 Aug 2026 06:10:00 -0400

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Form SCHEDULE 13G/A Rezolute, Inc. Filed by: BANK OF AMERICA CORP /DE/

Wed, 12 Aug 2026 12:27:00 -0400

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Form SCHEDULE 13G/A Rezolute, Inc. Filed by: BANK OF AMERICA CORP /DE/

Wed, 12 Aug 2026 12:27:00 -0400

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Form SCHEDULE 13G Rezolute, Inc. Filed by: Dellora Investments LP

Wed, 12 Aug 2026 11:05:00 -0400

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Form SCHEDULE 13G Rezolute, Inc. Filed by: Dellora Investments LP

Wed, 12 Aug 2026 11:05:00 -0400

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H.C. Wainwright Reiterates Buy Rating on Rezolute (RZLT)

Thu, 30 Jul 2026 06:53:01 -0400

H.C. Wainwright analyst Douglas Tsao reiterated a Buy rating and $5.00 price target on Rezolute (NASDAQ: RZLT).

The analyst commented: "As part of our “Biopharma Deep Dive” series, we hosted Rezolute Chief Medical Officer Dr. Brian Roberts to discuss ersodetug following the Phase 3 sunRIZE miss and ahead of the final upLIFT readout. The discussion included management’s recent FDA interaction, the durability emerging in the open-label extension (OLE), and the objective tumor-HI responses, all of which point to a program that still has a path to market. We remain confident that ersodetug is pharmacologically active and potentially differentiated. With Breakthrough Therapy

Rezolute to Participate in the BTIG Virtual Biotechnology Conference

Tue, 21 Jul 2026 07:30:00 -0400

REDWOOD CITY, Calif., July 21, 2026 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT) (“Rezolute” or the “Company”), a late-stage ultra-rare disease company focused on treating refractory hypoglycemia caused by a congenital or any acquired form of hyperinsulinism (HI), today announced that management will participate in the BTIG Virtual Biotechnology Conference, taking place July 28-29, 2026.

Management will be participating in one-on-one investor meetings throughout the conference. Investors interested in scheduling a meeting with the Rezolute management team should contact their BTIG representative.

About Rezolute, Inc.

Rezolute is a late-stage ultra-rare disease

Rezolute to Participate in the BTIG Virtual Biotechnology Conference

Tue, 21 Jul 2026 07:30:00 -0400

About Rezolute, Inc.

Rezolute is a late-stage ultra-rare disease

Form 4 Rezolute, Inc. For: Jul 02 Filed by: ROBERTS BRIAN KENNETH

Tue, 07 Jul 2026 18:36:00 -0400

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Form 4 Rezolute, Inc. For: Jul 02 Filed by: ROBERTS BRIAN KENNETH

Tue, 07 Jul 2026 18:36:00 -0400

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Form 4 Rezolute, Inc. For: Jul 02 Filed by: Elam Nevan C

Tue, 07 Jul 2026 17:27:00 -0400

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Form 4 Rezolute, Inc. For: Jul 02 Filed by: Elam Nevan C

Tue, 07 Jul 2026 17:27:00 -0400

si-local-file:///var/storage/secattach/20260707/26742790.html

Form 4 Rezolute, Inc. For: Jul 02 Filed by: Evans Daron

Tue, 07 Jul 2026 17:26:00 -0400

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Form 4 Rezolute, Inc. For: Jul 02 Filed by: Evans Daron

Tue, 07 Jul 2026 17:26:00 -0400

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Rezolute presents hyperinsulinism data at Endocrine Society meeting

Wed, 17 Jun 2026 07:03:21 -0400

Rezolute, Inc. (Nasdaq: RZLT) presented four data analyses at the Annual Meeting of the Endocrine Society, covering natural history outcomes in congenital hyperinsulinism (HI) and clinical results from its ersodetug program.

Two poster presentations examined the natural history and adverse outcomes of congenital HI, using a meta-analysis of existing literature and a claims-based analysis to quantify disease complications. A third poster reported results from a case series of nine patients with refractory hypoglycemia due to malignant insulinoma and non-islet cell tumors enrolled in the company's Expanded Access Program. According to the press release, 75% of those patients receiving intravenous dextrose or

Rezolute presents hyperinsulinism data at Endocrine Society meeting

Wed, 17 Jun 2026 07:03:21 -0400

Rezolute Highlights Results Presented from Natural History Outcomes Studies and its Ersodetug Clinical Program in Hyperinsulinism at Annual Meeting of the Endocrine Society

Wed, 17 Jun 2026 07:00:00 -0400

Presentations included analyses of natural history and adverse outcomes in congenital hyperinsulinism (HI), as well as previously reported results from the Company’s Phase 3 sunRIZE study in congenital HI and a case series from its Expanded Access Program (EAP) in tumor HI

REDWOOD CITY, Calif., June 17, 2026 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT) (“Rezolute” or the “Company”), a late-stage ultra-rare disease company focused on treating refractory hypoglycemia caused by a congenital or any acquired form of hyperinsulinism (HI), today highlighted four data presentations delivered at the Annual Meeting of the Endocrine Society (ENDO).

Rezolute Highlights Results Presented from Natural History Outcomes Studies and its Ersodetug Clinical Program in Hyperinsulinism at Annual Meeting of the Endocrine Society

Wed, 17 Jun 2026 07:00:00 -0400

Rezolute (RZLT) PT Raised to $11 at Guggenheim

Mon, 15 Jun 2026 06:53:13 -0400

(Updated - June 15, 2026 6:53 AM EDT)

Guggenheim analyst Debjit Chattopadhyay raised the price target on Rezolute (NASDAQ: RZLT) to $11.00 (from $6.00) while maintaining a Buy rating.

The analyst commented: "We are increasing our PT to $11, i.e., ~175% potential upside from the current level. Our thesis is based on the high likelihood of a positive readout from the upLIFT registrational study during 2H26. Recall, the recent interim update, mechanistically and clinically de-risks the upLIFT readout. We model ~$850M in peak sales in the U.S. alone (at $750k gross and $540k compliance-adjusted net WAC) in tHI, which is backed by