Earnings summaries and quarterly performance for Rezolute.
Executive leadership at Rezolute.
Board of directors at Rezolute.
Research analysts covering Rezolute.
Recent press releases and 8-K filings for RZLT.
Rezolute's ersodetug Phase 3 Trial Fails, Shares Plummet
RZLT
Legal Proceedings
Profit Warning
- On December 11, 2025, Rezolute, Inc. (NASDAQ: RZLT) shares crashed as much as 90% during intraday trading following the announcement of the failure of its Phase 3 sunRIZE trial for ersodetug ("erso").
- The erso trial, which aimed to treat hypoglycemia caused by hyperinsulinism, did not meet its primary or secondary endpoints, showing no statistically significant reduction in hypoglycemia events compared to placebo.
- This outcome contrasts with previous company assurances regarding erso's potential efficacy and commercial prospects.
- National shareholders rights firm Hagens Berman has opened an investigation into whether Rezolute may have misled investors.
11 hours ago
Rezolute's Shares Decline Following Failed Drug Trial
RZLT
Legal Proceedings
Profit Warning
- On December 11, 2025, Rezolute, Inc. (NASDAQ: RZLT) shares crashed as much as 90% during intraday trading after its Phase 3 sunRIZE trial for ersodetug (erso), a potential treatment for hypoglycemia caused by hyperinsulinism, failed to meet its primary and secondary endpoints.
- The trial results contradicted previous assurances from Rezolute in mid-November 2025, which highlighted erso's potential to eradicate hypoglycemia and an "incredible market opportunity".
- Shareholders rights firm Hagens Berman has initiated an investigation into whether Rezolute may have misled investors about erso’s efficacy and commercial prospects, encouraging affected investors to submit their losses.
2 days ago
Rezolute announces Phase 3 trial failure for ersodetug, leading to significant stock drop
RZLT
Legal Proceedings
Demand Weakening
Profit Warning
- On December 11, 2025, Rezolute, Inc. (RZLT) shares cratered as much as 90% during intraday trading after the company announced the failure of its Phase 3 sunRIZE trial for ersodetug ("erso").
- The trial for erso, a potential treatment for hypoglycemia caused by hyperinsulinism, did not meet its primary or secondary endpoints, showing no statistically significant reduction in hypoglycemia events compared to placebo.
- Shareholder rights firm Hagens Berman has initiated an investigation into whether Rezolute may have misled investors about erso's efficacy and commercial prospects.
3 days ago
Rezolute's Phase 3 Trial Fails, Shares Plummet
RZLT
Demand Weakening
Legal Proceedings
- Rezolute, Inc. (RZLT) shares dropped as much as 90% on December 11, 2025, following the announcement of the failure of its Phase 3 sunRIZE trial for ersodetug ("erso").
- The Phase 3 trial for erso, a potential treatment for hypoglycemia caused by hyperinsulinism, did not meet its primary or secondary endpoints.
- This development has prompted national shareholders rights firm Hagens Berman to open an investigation into whether Rezolute may have previously misled investors about erso's efficacy and commercial prospects.
7 days ago
Rezolute Shares Tank 90% Following Lead Asset Trial Failure
RZLT
Legal Proceedings
Profit Warning
- Rezolute, Inc. (RZLT) shares crashed as much as 90% on December 11, 2025, after the company announced the failure of its Phase 3 sunRIZE trial for ersodetug.
- The trial for ersodetug, a potential treatment for hypoglycemia caused by hyperinsulinism, did not meet its primary or secondary endpoints.
- National shareholders rights firm Hagens Berman has opened an investigation into whether Rezolute may have misled investors about ersodetug’s efficacy and commercial prospects.
- Following the news, analysts reportedly slashed Rezolute’s rating from outperform to neutral and the price target from $12 to $1.
7 days ago
Rezolute Shares Tumble Following Failed Phase 3 Clinical Trial
RZLT
Legal Proceedings
Profit Warning
- Faruqi & Faruqi, LLP is investigating potential claims against Rezolute, Inc. (NASDAQ: RZLT) after its stock experienced a significant decline.
- On December 11, 2025, Rezolute's shares collapsed by 85–90%, falling from approximately $10.94 to an intraday low near $0.90.
- This sharp decline was triggered by the failure of its Phase 3 sunRIZE clinical trial for ersodetug, the company's lead drug candidate for congenital hyperinsulinism.
- The trial did not meet its primary and key secondary endpoints, with the highest dose showing no statistically significant reduction in hypoglycemia events compared to placebo.
7 days ago
Rezolute Reports Negative Phase III Sunrise Study Results for Ersodetug in Congenital HI
RZLT
Layoffs
- Rezolute Inc.'s Phase III Sunrise study for ersodetug in congenital hyperinsulinism (HI) did not achieve statistical significance for its primary and secondary endpoints.
- Management attributes the study outcome to inherent problems in conducting studies in ultra-rare pediatric populations and a significant placebo effect, but maintains belief in the drug's activity.
- As of September 30, 2025, the company had $150 million in cash and is implementing measures to decrease operating expenses, including an expected reduction in force.
- The FDA has agreed to a streamlined, open-label study design for ersodetug in the tumor HI indication, which is expected to be completed next year.
8 days ago
RZLT Announces Phase 3 Sunrise Study Results for Ersodetug
RZLT
Layoffs
New Projects/Investments
- RZLT's Phase 3 Sunrise study for ersodetug in patients with congenital HI did not achieve statistical significance for its primary and secondary endpoints.
- Despite the study outcome, the company believes its drug works and plans to engage with the FDA to find a path forward for this ultra-rare pediatric indication, arguing that the traditional study methodology is unsuitable.
- The negative results for the congenital HI study do not impact the tumor HI program, which has a separate IND and a streamlined open-label study design agreed upon with the FDA, with a new paradigm for registration.
- As of September 30, 2025, RZLT had $150 million in cash and is implementing cost-cutting measures, including an expected reduction in force, to extend its cash runway through 2027 to fund the tumor study.
8 days ago
Rezolute Inc. Announces Phase 3 Sunrise Study Failure and Cost Reductions
RZLT
Layoffs
Profit Warning
- Rezolute Inc.'s Phase 3 Sunrise study for ersodetug in congenital hyperinsulinism (HI) failed to meet its primary and secondary endpoints.
- The company believes the drug works but attributes the study's outcome to the unsuitability of traditional randomized placebo-controlled studies for ultra-rare pediatric indications, noting that over 50 children are currently on ersodetug in an open-label extension.
- Rezolute reported $150 million in cash as of September 30, 2025, but plans to reduce operating expenses, including an expected reduction in force.
- The negative results for the congenital HI study do not affect the tumor HI program, which is a separate IND with a clear development pathway and a different mechanistic endpoint agreed upon with the FDA.
8 days ago
Rezolute, Inc. Provides Update on Ersodetug Development Program
RZLT
Product Launch
New Projects/Investments
- Rezolute, Inc. held an investor event on November 10, 2025, to provide an update on its Ersodetug Development Program.
- The company anticipates topline results for its Phase 3 sunRIZE study in Congenital Hyperinsulinism (HI) in December 2025, and for the Phase 3 upLIFT study in Tumor HI in the second half of 2026.
- In 2025, Rezolute received Breakthrough Therapy Designations from the FDA for both congenital HI and tumor HI, and achieved alignment with the FDA on clinical data packages to support Biologics License Application (BLA) filings for both indications.
- The estimated initial combined U.S. addressable market opportunity for Ersodetug across congenital HI, malignant insulinoma, and NICTH is 4,500 patients, with each indication representing approximately 1,500 patients.
Nov 12, 2025, 11:09 AM
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