Rezolute to Present Results from its Phase 3 sunRIZE Study in Congenital Hyperinsulinism at the Pediatric Endocrine Society (PES) Annual Meeting
Rhea-AI Summary
Rezolute (Nasdaq: RZLT) will present Phase 3 sunRIZE results for ersodetug in congenital hyperinsulinism at the Pediatric Endocrine Society Annual Meeting, April 30–May 3, 2026 in San Francisco. The oral presentation on May 1, 2026, 8:15–9:15 a.m. PT will include topline, pre-specified, and post-hoc analyses, with Diva D. De León-Crutchlow, MD, MSCE as presenter.
The company says the additional analyses continue to demonstrate target engagement and therapeutic benefit of ersodetug; attendees can consult the PES schedule for details.
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News Market Reaction – RZLT
In the Apr 21 session, RZLT declined 2.67%, reflecting a moderate negative market reaction. Argus tracked a peak move of +8.8% during that session. Our momentum scanner triggered 10 alerts that day, indicating notable trading interest and price volatility.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Previous Clinical trial Reports
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Jan 07 | sunRIZE/EAP data update | Negative | +23.0% | Detailed Phase 3 sunRIZE miss and positive tumor HI EAP data. |
| Dec 11 | sunRIZE topline results | Negative | -87.2% | First disclosure that Phase 3 sunRIZE failed primary and key secondary endpoints. |
| Sep 02 | upLIFT design alignment | Positive | +0.7% | FDA alignment on streamlined single‑arm upLIFT Phase 3 tumor HI trial. |
| Jul 09 | Baseline data presentation | Positive | +6.2% | ENDO 2025 presentation of fully enrolled sunRIZE baseline data. |
| May 28 | sunRIZE enrollment complete | Positive | +3.1% | Completion of Phase 3 sunRIZE enrollment with 62 participants. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Clinical trial news for ersodetug has produced volatile, often negative average moves, with the largest drop tied to the first disclosure that sunRIZE missed primary endpoints.
Over the past year, Rezolute has advanced ersodetug through key Phase 3 milestones in congenital and tumor hyperinsulinism. Earlier clinical updates covered completion of sunRIZE enrollment, baseline data, FDA-aligned design changes for the upLIFT tumor HI trial, and ultimately topline sunRIZE data showing primary and key secondary endpoints were not met. Subsequent communications emphasized pharmacologic activity, CGM trends, and expanded access data. Today’s PES presentation announcement continues this communication arc by sharing additional pre-specified and post-hoc analyses from sunRIZE.
Key Terms
phase 3 medical
congenital hyperinsulinism medical
randomized medical
double-blind medical
placebo-controlled medical
post-hoc medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
Oral presentation will include previously announced topline results as well as pre-specified and post-hoc data updates
REDWOOD CITY, Calif., April 21, 2026 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT) (“Rezolute” or the “Company”), a late-stage rare disease company focused on treating hypoglycemia caused by all forms of hyperinsulinism (HI), today announced that results from the Phase 3 sunRIZE study of ersodetug in congenital HI were accepted for an oral presentation at the Pediatric Endocrine Society (PES) Annual Meeting being held April 30-May 3, 2026, in San Francisco, CA. In addition to the previously reported topline results, the presentation will also include results from pre-specified and post-hoc sunRIZE analyses, which the Company believes continue to demonstrate target engagement and the therapeutic benefit of ersodetug.
Presentation Title: Top-Line Results From a Global, Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Study (sunRIZE)
Format: Oral presentation
Presenter: Diva D. De León-Crutchlow, MD, MSCE
Session Date and Time: Friday, May 1, 2026, from 8:15 a.m. – 9:15 a.m. PT
Session Title: Oral Abstracts #1
For more information on the conference presentation schedule, please visit the PES Annual Meeting website.
About sunRIZE
The Phase 3 sunRIZE study (RZ358-301) was a multi-center, randomized, double-blind, placebo-controlled, parallel arm study designed to evaluate the efficacy and safety of ersodetug in patients with congenital hyperinsulinism (HI), ages 3 months to 45 years old, who were experiencing continued hypoglycemia on currently available standard of care (SOC). Eligible participants were randomized to one of three treatment arms to receive either ersodetug (5 or 10 mg/kg) or matched placebo-control as add on to existing SOC. Study drug was administered every other week during an initial loading phase, and then every 4 weeks during the 6-month controlled pivotal treatment period. Following the pivotal treatment phase of the study, participants could roll-over into an optional open-label extension phase to continue to receive ersodetug.
The study enrolled 63 participants in more than a dozen countries around the world, inclusive of U.S. patients. The primary and key secondary efficacy endpoints in the study were the change from baseline in the average number of hypoglycemia events per week and the average percent time in hypoglycemia, respectively, over six months of treatment.
About Ersodetug
Ersodetug is a fully human monoclonal antibody that binds allosterically to the insulin receptor to decrease receptor over-activation by insulin and related substances (such as IGF-2) in the setting of hyperinsulinism (HI), thereby improving hypoglycemia. Because ersodetug acts downstream from the pancreas, it has the potential to be universally effective at treating hypoglycemia due to any congenital or acquired form of HI.
About Rezolute, Inc.
Rezolute is a late-stage rare disease company focused on treating hypoglycemia caused by hyperinsulinism (HI). The Company’s antibody therapy, ersodetug, is designed to treat all forms of HI and has been studied in clinical trials and used in real-world cases for the treatment of both congenital and tumor HI. For more information, visit www.rezolutebio.com.
Forward-Looking Statements
This release, like many written and oral communications presented by Rezolute and our authorized officers, may contain certain forward-looking statements regarding our prospective performance and strategies within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934, as amended. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995 and are including this statement for purposes of said safe harbor provisions. Forward-looking statements, which are based on certain assumptions and describe future plans, strategies, and expectations of Rezolute, are generally identified by use of words such as "anticipate," "believe," "estimate," "expect," "intend," "plan," "project," "seek," "strive," "try," or future or conditional verbs such as "could," "may," "should," "will," "would," or similar expressions. These forward-looking statements include, but are not limited to, the potential efficacy of ersodetug in treating hypoglycemia. Our ability to predict results or the actual effects of our plans or strategies is inherently uncertain. Accordingly, actual results may differ materially from anticipated results. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. Except as required by applicable law or regulation, Rezolute 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 our filings with the SEC, including the Risk Factors contained in Rezolute’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, which are available at the U.S. Securities and Exchange Commission’s website at www.sec.gov. You are urged to consider these factors carefully in evaluating the forward-looking statements in this release and are cautioned not to place undue reliance on such forward-looking statements, which are qualified in their entirety by this cautionary statement.
Rezolute Contacts:
Christen Baglaneas
508-272-6717
Carrie McKim
336-608-9706
