Rezolute Shares Plunge 90% After Phase 3 Trial Failure

Written by Emily J. Thompson, Senior Investment Analyst

Source: Globenewswire

Updated: 6 days ago

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RZLT+5.79%

Should l Buy RZLT?

Source: Globenewswire

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.

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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

Wedbush

Neutral

maintain

$1 -> $2

2026-01-08

Reason

Wedbush

Price Target

$1 -> $2

AI Analysis

2026-01-08

maintain

Neutral

Reason

Wedbush raised the firm's price target on Rezolute to $2 from $1 and keeps a Neutral rating on the shares. The firm notes the company reported PK/PD data and detailed glycemic control outcomes from the Phase 3 sunRIZE study of ersodetug in congenital hyperinsulinism. Wedbush believes that the new data demonstrates ersodetug's activity in modulating insulin receptors to reduce both events and time in hypoglycemia in treated patients, although whether the magnitude of benefit is sufficient to support an FDA approval remains unclear.

Guggenheim

Buy

downgrade

$15 -> $6

2025-12-12

Reason

Guggenheim

Price Target

$15 -> $6

2025-12-12

downgrade

Buy

Reason

Guggenheim lowered the firm's price target on Rezolute to $6 from $15 and keeps a Buy rating on the shares. Following the failure of the sunRIZE trial, the firm is eliminating cHI from its model despite managment's "optimism" on a potential path forward, the analyst tells investors. The firm's lower target reflects the elimination of cHI, a lower price point forecast for tHI and lower odds of success, until proven otherwise, for tHI, the analyst noted.

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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

6 hours agoGlobenewswire

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.

Faruqi & Faruqi Investigates Investor Losses in Rezolute

2 days agoPRnewswire

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.

Rezolute Reports Q2 Loss, Downgrades Ahead

3 days agoseekingalpha

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.