Rezolute Shares Phase 3 sunRIZE Data on Ersodetug, Plans FDA Meeting
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jan 07 2026
0mins
Should l Buy RZLT?
Source: Globenewswire
- Clinical Trial Results: Rezolute's sunRIZE study did not meet its primary or key secondary endpoints, yet the company believes the data supports ersodetug's activity in treating congenital hyperinsulinism, demonstrating target drug concentrations and biomarker responses that may indicate future clinical efficacy.
- Patient Feedback: In the open-label extension phase, all 59 participants opted to continue receiving ersodetug, with treatment durations ranging from six weeks to 18 months, and several children have stopped other therapies, suggesting potential efficacy of ersodetug.
- FDA Interaction Plans: The company plans to meet with the FDA in Q1 2026 to discuss clinical outcomes under its Breakthrough Therapy Designation, aiming to advance treatment pathways for congenital hyperinsulinism despite the lack of statistical significance in the sunRIZE study.
- Tumor HI Treatment Progress: Rezolute has provided ersodetug to over a dozen patients with tumor hyperinsulinism, with 75% achieving complete discontinuation of IV glucose infusion, highlighting the drug's potential efficacy across various forms of hyperinsulinism.
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Analyst Views on RZLT
Wall Street analysts forecast RZLT stock price to rise
9 Analyst Rating
5 Buy
4 Hold
0 Sell
Moderate Buy
Current: 3.630
Low
2.00
Averages
6.29
High
20.00
Current: 3.630
Low
2.00
Averages
6.29
High
20.00
About RZLT
Rezolute, Inc. is a late-stage rare disease company, which is focused on improving outcomes for individuals with hypoglycemia caused by hyperinsulinism (HI). Its lead clinical asset, Ersodetug (formerly RZ358), is a potential treatment for hypoglycemia caused by multiple forms of hyperinsulinism including congenital HI and tumor HI. Ersodetug is an intravenously administered human monoclonal antibody that binds to a unique site (allosteric) on the insulin receptor in insulin target tissues, such as in the liver, fat, and muscle. Congenital is a rare pediatric genetic disorder characterized by excessive production of insulin by the pancreas. RZ402, which is an oral plasma kallikrein inhibitor (PKI) being developed as a potential therapy for the chronic treatment of diabetic macular edema (DME). DME is a vascular complication of diabetes and a leading cause of blindness. RZ402 is designed to block bradykinin production and its resulting effects on vascular leakage and inflammation.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Faruqi & Faruqi Investigates Rezolute Losses for Investors
- Stock Price Plunge: Rezolute, Inc. shares plummeted on December 11, 2025, due to disappointing results from its Phase 3 sunRIZE clinical trial, collapsing from approximately $10.94 to $0.90, reflecting an 85-90% drop and indicating severe market confidence erosion in its lead drug candidate.
- Legal Investigation Initiated: Faruq & Faruqi, LLP is investigating potential claims against Rezolute, encouraging investors who suffered significant losses to contact securities litigation partner Josh Wilson directly to discuss their legal rights and possible remedies.
- Clinical Trial Failure: The company's lead drug candidate, ersodetug, failed to meet both primary and key secondary endpoints, leading to a significant decline in investor confidence and potentially triggering further legal actions.
- Investor Loss Warning: Since its founding in 1995, Faruqi & Faruqi has recovered hundreds of millions for investors, and the current investigation may provide legal support for affected investors seeking compensation.
See More
Faruqi & Faruqi Investigates Investor Losses in Rezolute
- Legal Investigation Initiated: Faruq & Faruqi LLP is investigating potential claims against Rezolute, Inc., aiming to provide legal support for investors who suffered significant losses, indicating possible legal liabilities for the company.
- Investor Rights Protection: The firm encourages investors who have incurred losses in Rezolute stock or options to contact partner Josh Wilson directly, highlighting its commitment to investor rights, which may impact the company's reputation.
- Historical Performance Review: Since its founding in 1995, Faruqi & Faruqi has recovered hundreds of millions of dollars for investors, showcasing its strong capabilities in securities law, potentially attracting more affected investors seeking assistance.
- Contact Information Provided: Faruqi & Faruqi has made direct contact numbers and additional information links available, facilitating legal consultations for investors, reflecting its emphasis on client service.
See More
Rezolute Reports Q2 Loss, Downgrades Ahead
- Earnings Miss: Rezolute's Q2 GAAP EPS of -$0.22 fell short of expectations by $0.03, indicating ongoing challenges in profitability that could undermine investor confidence and future funding opportunities.
- Cash Position: As of December 31, 2025, the company's cash, cash equivalents, and marketable securities totaled $132.9 million, down from $167.9 million as of June 30, 2025, reflecting increased liquidity pressure that may restrict operational capabilities and growth initiatives.
- Stock Price Reaction: Rezolute shares fell 1.51% in after-hours trading, suggesting that the market's reaction to the earnings report indicates investor concerns about the company's future prospects, potentially leading to further stock volatility.
- Asset Downgrade: Following disappointing results from the sunRIZE trial, Rezolute's lead asset faces a downgrade, with analysts lowering their rating to “Sell,” which could negatively impact the company's financing ability and market trust.
See More
Rezolute Shares Plunge 90% After Phase 3 Trial Failure
- Trial Failure Announcement: On December 11, 2025, Rezolute announced that its Phase 3 sunRIZE trial for ersodetug failed to meet its primary endpoint, causing shares to plummet by as much as 90% during intraday trading, severely undermining investor confidence.
- Investigation into Misleading Claims: Hagens Berman has launched an investigation into whether Rezolute misled investors regarding ersodetug's efficacy and market potential, despite previous assurances of its ability to significantly alleviate hypoglycemia and capitalize on a substantial market opportunity.
- Analyst Downgrades: Following the trial results, analysts quickly downgraded Rezolute's rating from outperform to neutral and slashed the price target from $12 to $1, reflecting a pessimistic outlook on the company's future prospects.
- Whistleblower Incentives: Hagens Berman is encouraging individuals with non-public information to assist in the investigation, highlighting that under the SEC Whistleblower program, those providing original information may receive rewards of up to 30% of any successful recovery, further motivating public participation in the inquiry.
See More
Faruqi & Faruqi Investigates Losses in Rezolute Stock
- Stock Price Plunge: Rezolute, Inc. shares plummeted on December 11, 2025, due to disappointing results from its Phase 3 sunRIZE clinical trial, collapsing from approximately $10.94 to $0.90, reflecting an 85-90% drop and investor disillusionment with the company's prospects.
- Legal Investigation Launched: Faruq & Faruqi LLP is investigating potential claims against Rezolute, urging investors who suffered significant losses to contact partner Josh Wilson directly, indicating the firm's commitment to protecting investor rights.
- Clinical Trial Failure: The lead drug candidate ersodetug failed to meet both primary and key secondary endpoints in clinical trials, leading to a significant decline in market confidence and the potential for increased legal actions against the company.
- Investor Rights Protection: Since its founding in 1995, Faruqi & Faruqi has recovered hundreds of millions for investors, showcasing its expertise in securities law and aiming to provide legal support for affected investors.
See More
Faruqi & Faruqi Investigates Rezolute Losses
- Legal Investigation Launched: Faruq & Faruqi LLP is investigating potential claims against Rezolute, Inc. after its stock plummeted on December 11, 2025, due to disappointing clinical trial results, leading to significant investor losses.
- Clinical Trial Failure: The Phase 3 sunRIZE clinical trial for Rezolute's lead drug candidate, ersodetug, failed to meet both primary and key secondary endpoints, severely impacting the drug's market prospects and investor confidence.
- Significant Investor Losses: As the trial results did not show statistical significance, Rezolute's stock price sharply declined, potentially resulting in millions of dollars in losses for investors, prompting Faruqi & Faruqi to encourage affected investors to discuss their legal options.
- Law Firm Background: Founded in 1995, Faruqi & Faruqi has recovered hundreds of millions for investors and has offices in New York, Pennsylvania, California, and Georgia, committed to protecting investor rights.
See More
Faruqi & Faruqi Investigates Rezolute Losses for Investors
- Stock Price Plunge: Rezolute, Inc. shares plummeted on December 11, 2025, due to disappointing results from its Phase 3 sunRIZE clinical trial, collapsing from approximately $10.94 to $0.90, reflecting an 85-90% drop and indicating severe market confidence erosion in its lead drug candidate.
- Legal Investigation Initiated: Faruq & Faruqi, LLP is investigating potential claims against Rezolute, encouraging investors who suffered significant losses to contact securities litigation partner Josh Wilson directly to discuss their legal rights and possible remedies.
- Clinical Trial Failure: The company's lead drug candidate, ersodetug, failed to meet both primary and key secondary endpoints, leading to a significant decline in investor confidence and potentially triggering further legal actions.
- Investor Loss Warning: Since its founding in 1995, Faruqi & Faruqi has recovered hundreds of millions for investors, and the current investigation may provide legal support for affected investors seeking compensation.
See More
Faruqi & Faruqi Investigates Investor Losses in Rezolute
- Legal Investigation Initiated: Faruq & Faruqi LLP is investigating potential claims against Rezolute, Inc., aiming to provide legal support for investors who suffered significant losses, indicating possible legal liabilities for the company.
- Investor Rights Protection: The firm encourages investors who have incurred losses in Rezolute stock or options to contact partner Josh Wilson directly, highlighting its commitment to investor rights, which may impact the company's reputation.
- Historical Performance Review: Since its founding in 1995, Faruqi & Faruqi has recovered hundreds of millions of dollars for investors, showcasing its strong capabilities in securities law, potentially attracting more affected investors seeking assistance.
- Contact Information Provided: Faruqi & Faruqi has made direct contact numbers and additional information links available, facilitating legal consultations for investors, reflecting its emphasis on client service.
See More
Rezolute Reports Q2 Loss, Downgrades Ahead
- Earnings Miss: Rezolute's Q2 GAAP EPS of -$0.22 fell short of expectations by $0.03, indicating ongoing challenges in profitability that could undermine investor confidence and future funding opportunities.
- Cash Position: As of December 31, 2025, the company's cash, cash equivalents, and marketable securities totaled $132.9 million, down from $167.9 million as of June 30, 2025, reflecting increased liquidity pressure that may restrict operational capabilities and growth initiatives.
- Stock Price Reaction: Rezolute shares fell 1.51% in after-hours trading, suggesting that the market's reaction to the earnings report indicates investor concerns about the company's future prospects, potentially leading to further stock volatility.
- Asset Downgrade: Following disappointing results from the sunRIZE trial, Rezolute's lead asset faces a downgrade, with analysts lowering their rating to “Sell,” which could negatively impact the company's financing ability and market trust.
See More
Rezolute Shares Plunge 90% After Phase 3 Trial Failure
- Trial Failure Announcement: On December 11, 2025, Rezolute announced that its Phase 3 sunRIZE trial for ersodetug failed to meet its primary endpoint, causing shares to plummet by as much as 90% during intraday trading, severely undermining investor confidence.
- Investigation into Misleading Claims: Hagens Berman has launched an investigation into whether Rezolute misled investors regarding ersodetug's efficacy and market potential, despite previous assurances of its ability to significantly alleviate hypoglycemia and capitalize on a substantial market opportunity.
- Analyst Downgrades: Following the trial results, analysts quickly downgraded Rezolute's rating from outperform to neutral and slashed the price target from $12 to $1, reflecting a pessimistic outlook on the company's future prospects.
- Whistleblower Incentives: Hagens Berman is encouraging individuals with non-public information to assist in the investigation, highlighting that under the SEC Whistleblower program, those providing original information may receive rewards of up to 30% of any successful recovery, further motivating public participation in the inquiry.
See More
Faruqi & Faruqi Investigates Losses in Rezolute Stock
- Stock Price Plunge: Rezolute, Inc. shares plummeted on December 11, 2025, due to disappointing results from its Phase 3 sunRIZE clinical trial, collapsing from approximately $10.94 to $0.90, reflecting an 85-90% drop and investor disillusionment with the company's prospects.
- Legal Investigation Launched: Faruq & Faruqi LLP is investigating potential claims against Rezolute, urging investors who suffered significant losses to contact partner Josh Wilson directly, indicating the firm's commitment to protecting investor rights.
- Clinical Trial Failure: The lead drug candidate ersodetug failed to meet both primary and key secondary endpoints in clinical trials, leading to a significant decline in market confidence and the potential for increased legal actions against the company.
- Investor Rights Protection: Since its founding in 1995, Faruqi & Faruqi has recovered hundreds of millions for investors, showcasing its expertise in securities law and aiming to provide legal support for affected investors.
See More
Faruqi & Faruqi Investigates Rezolute Losses
- Legal Investigation Launched: Faruq & Faruqi LLP is investigating potential claims against Rezolute, Inc. after its stock plummeted on December 11, 2025, due to disappointing clinical trial results, leading to significant investor losses.
- Clinical Trial Failure: The Phase 3 sunRIZE clinical trial for Rezolute's lead drug candidate, ersodetug, failed to meet both primary and key secondary endpoints, severely impacting the drug's market prospects and investor confidence.
- Significant Investor Losses: As the trial results did not show statistical significance, Rezolute's stock price sharply declined, potentially resulting in millions of dollars in losses for investors, prompting Faruqi & Faruqi to encourage affected investors to discuss their legal options.
- Law Firm Background: Founded in 1995, Faruqi & Faruqi has recovered hundreds of millions for investors and has offices in New York, Pennsylvania, California, and Georgia, committed to protecting investor rights.
See More
