Rezolute, Inc. (RZLT) Rezolute, Inc., a late-stage rare disease company, focused on improving outcomes for individuals with hypoglycemia caused by hyperinsulinism in the United States. Its lead clinical asset is ersodetug, an intravenously administered human monoclonal antibody that is in Phase 3 clinical trial for the treatment of congenital hyperinsulinism, an ultra-rare pediatric genetic disorder, as well as for the treatment of hypoglycemia; and clinical trials of ersodetug for tumor hyperinsulinism. The company was formerly known as AntriaBio, Inc. and changed its name to Rezolute, Inc. in December 2017. Rezolute, Inc. was founded in 2010 and is headquartered in Redwood City, California.
Sector: Pharmaceutical Preparations
Industry: Biotechnology
Rezolute, Inc. NASDAQ:RZLT Healthcare · Biotechnology
Mkt Cap $382.05M
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Press Release ⚠ 2
Rezolute Announces Completion of Enrollment in Phase 3 upLIFT Study of Ersodetug in Tumor Hyperinsulinism
Rezolute completed enrollment in its Phase 3 upLIFT study of ersodetug in tumor hyperinsulinism, with topline data expected mid-December 2026.
The single-arm registrational study enrolled 16 participants; interim results showed 7 of the first 8 participants met the primary endpoint, each achieving complete discontinuation of intravenous glucose.
Favorable topline data could position Rezolute to advance both tumor HI and congenital HI indications in 2027, making the December readout a key binary catalyst for the company.
• 18d ago AI analysis › Press Release ⚠ 2
Rezolute Announces FDA Recommendation to Hold a Pre-BLA Meeting as a Precursor to Submitting a Biologics License Application (BLA) for Congenital Hyperinsulinism
Rezolute announced the FDA recommended a pre-BLA meeting for ersodetug in congenital hyperinsulinism following a preliminary review of detailed Phase 3 sunRIZE data.
SunRIZE missed its prespecified primary endpoint (hypoglycemia reduction by finger-stick SMBG) and key secondary endpoint, but FDA acknowledged SMBG limitations and reviewed CGM analyses showing clinically relevant improvements before encouraging the BLA pathway.
FDA explicitly did not opine on approvability; Rezolute will finalize its BLA strategy after topline results from the upLIFT tumor-HI study, expected this quarter.
The open-label extension continues with high retention, nine months to over two years of ersodetug exposure, and reduced use of standard-of-care therapies.
• 27d ago AI analysis › Press Release ⚠ 4
Rezolute Reports Fourth Quarter and Full Year Fiscal 2026 Financial Results and Provides Business Update
Rezolute reported fiscal 2026 results with cash and investments of $107.8 million against a full-year net loss of $77.6 million, implying roughly a year and a half of runway at the current burn.
In tumor HI, the Phase 3 upLIFT study continues enrolling with a seventh of eight participants meeting the responder criterion; topline results are expected before the end of 2026.
The congenital HI program faces uncertainty: the Phase 3 sunRIZE study missed its primary endpoint and data remain under FDA review, with the company acknowledging the Agency could require a new randomized controlled trial that would adversely impact the indication.
Q4 net loss narrowed to $20.5 million from $24.4 million a year ago, though G&A costs rose on commercial-preparation spending.
• 1mo ago AI analysis › Press Release ⚠ 4
Rezolute Provides Update on FDA Review of its Phase 3 sunRIZE Study Results in Congenital Hyperinsulinism
FDA's review of the Phase 3 sunRIZE data for ersodetug in congenital hyperinsulinism remains ongoing, and because the review is being conducted outside the customary formal meeting process there is no timeline for feedback.
Rezolute submitted additional CGM-based datasets and analyses in June 2026 following a March Type B meeting, and reports consistent glycemic improvements versus placebo, including 50% or greater reductions in average daily percent time in hypoglycemia and average weekly hypoglycemia events at both dose levels.
The open-label extension continues with high retention and cumulative ersodetug treatment of roughly nine months to well over two years, alongside a notable reduction in the use of background standard-of-care therapies.
The company cautions that FDA could determine the only path forward for congenital HI is a new randomized controlled trial, while the Phase 3 upLIFT study in tumor HI remains on track to report topline results before the end of 2026.
• 1mo ago AI analysis › Press Release
Rezolute to Participate in Upcoming Investor Conferences
Rezolute announced management will participate in three investor conferences in September 2026: the Cantor Global Healthcare Conference (September 9-11), the H.C. Wainwright 28th Annual Global Investment Conference (September 14-16), and the Morgan Stanley 24th Annual Global Healthcare Conference (September 14-16).
Management will take part in fireside chats and one-on-one investor meetings, with meetings arranged through Cantor, H.C. Wainwright, and Morgan Stanley representatives.
The release contains no new clinical, financial, or regulatory updates on the company or its antibody therapy ersodetug; it is a routine IR calendar announcement.
• 1mo ago AI analysis › Press Release
Rezolute to Participate in the BTIG Virtual Biotechnology Conference
Rezolute management will participate in the BTIG Virtual Biotechnology Conference scheduled for July 28-29, 2026.
One-on-one investor meetings will be available throughout the event for interested parties who contact their BTIG representative.
The company focuses on treating refractory hypoglycemia caused by hyperinsulinism, with its lead asset being the antibody therapy ersodetug.
• 3mo ago AI analysis › Press Release
Rezolute Highlights Results Presented from Natural History Outcomes Studies and its Ersodetug Clinical Program in Hyperinsulinism at Annual Meeting of the Endocrine Society
Rezolute highlighted data presentations at the Endocrine Society meeting, reviewing previously reported results from the Phase 3 sunRIZE study of ersodetug in congenital hyperinsulinism.
An Expanded Access Program case series showed that 75% of tumor HI patients achieved complete discontinuation of IV dextrose/TPN.
Separate presentations analyzed the natural history and adverse outcomes of congenital HI to support future health economics and potential launch.
• 4mo ago AI analysis › Press Release ⚠ 2
Rezolute Announces Four Presentations at the Upcoming Annual Meeting of the Endocrine Society
Rezolute will present four abstracts at the Endocrine Society’s annual meeting, including an oral presentation on the Phase 3 sunRIZE study results.
The sunRIZE study previously failed to meet its primary and key secondary efficacy endpoints in December 2025, though post-hoc analyses showed nominal glycemic improvements.
The FDA has encouraged Rezolute to submit comprehensive datasets for independent evaluation, and the company is also presenting data on compassionate use of ersodetug in tumor-associated hyperinsulinism.
• 4mo ago AI analysis › Press Release ● Major ⚠ 3
Rezolute Announces Positive Interim Data for its Phase 3 upLIFT Study of Ersodetug in Tumor Hyperinsulinism
Rezolute reported positive interim data from its Phase 3 upLIFT study of ersodetug in tumor hyperinsulinism. Of the 8 participants enrolled so far (50% of the planned 16), 6 met the primary endpoint of at least a 50% reduction in IV glucose requirements.
All 6 responders also achieved complete discontinuation of intravenous glucose. One participant withdrew due to cancer progression and is counted as a non-responder; the 8th is still dosing. No drug-related adverse events were reported.
Topline results for the fully enrolled study are expected in the second half of 2026. Management highlighted these results as supporting ersodetug’s potential as a universal treatment for refractory hypoglycemia, contrasting with the confounded results of the earlier sunRIZE study in pediatric congenital HI.
• 4mo ago AI analysis › Press Release ● Major
Rezolute Reports Third Quarter Fiscal 2026 Financial Results and Provides Business Update
globenewswire.com • 5mo ago Press Release
Rezolute to Participate in Upcoming Investor Conferences
globenewswire.com • 5mo ago Press Release ⚠ 3
Rezolute Announces Oral Presentation of Results From its Phase 3 sunRIZE Study of Ersodetug in Patients with Congenital Hyperinsulinism at the Pediatric Endocrine Society Annual Meeting
Rezolute presented expanded Phase 3 data showing ersodetug improved glycemic control on CGM measures, despite the sunRIZE study missing its primary endpoint. Following a Type B meeting, the FDA acknowledged issues with the primary endpoint and requested the broader study dataset to determine the next steps for the program.
Detailed analyses revealed clinically relevant reductions in hypoglycemia events of 50-80% and increases in time in normoglycemia compared to placebo. All 59 study completers entered the open-label extension, with 57 remaining and showing sustained benefit, including a significant reduction in the use of background standard of care therapies.
Management views the CGM data as evidence of target engagement and therapeutic benefit for Congenital Hyperinsulinism. The company is now preparing to submit the full data to the FDA for evaluation.
• 6mo ago AI analysis › Press Release ● Major
Rezolute Provides Update on its Congenital Hyperinsulinism Program Following FDA Meeting
globenewswire.com • 7mo ago 
