Rezolute, Inc. (NASDAQ: RZLT) experienced a dramatic 90% intraday stock price decline on December 11, 2025, after announcing that its Phase 3 sunRIZE trial for ersodetug failed to meet primary and secondary endpoints for treating hypoglycemia caused by hyperinsulinism. The failure contradicted the company's previous assurances about the drug's efficacy and market potential, prompting shareholder rights firm Hagens Berman to investigate potential investor fraud.

Rezolute's Phase 3 sunRIZE study in congenital hyperinsulinism failed to meet its primary and key secondary endpoints. While the top dose of ersodetug (10 mg/kg) showed a 45% reduction in hypoglycemia events compared to 40% in the placebo arm, this marginal difference represents a study failure. The company plans to meet with the FDA regarding the path forward.

Rezolute's stock plummeted on December 11, 2025, following disappointing results from its Phase 3 sunRIZE clinical trial for ersodetug. The trial failed to meet both primary and key secondary endpoints, with the highest dose showing statistically insignificant reductions in hypoglycemia events versus placebo. Securities law firm Faruqi & Faruqi is investigating potential claims on behalf of affected investors.

Pomerantz LLP is investigating potential securities fraud claims against XOMA Royalty Corporation following a significant stock price decline. The investigation was triggered by disappointing Phase 3 trial results from development partner Rezolute for the drug ersodetug, which failed to meet primary and secondary endpoints in treating congenital hyperinsulinism. XOMA's stock fell 22.76% on the news.

Rezolute, Inc. shares collapsed approximately 85-90% on December 11, 2025, after the company's Phase 3 sunRIZE clinical trial for its lead drug candidate ersodetug failed to meet primary and key secondary endpoints in treating congenital hyperinsulinism. The stock dropped from around $10.94 to an intraday low near $0.90, triggering Nasdaq volatility halts.

Rezolute's stock plummeted on December 11, 2025, following disappointing results from its Phase 3 sunRIZE clinical trial for ersodetug, a lead drug candidate for congenital hyperinsulinism. The study failed to meet its primary and key secondary endpoints, with the highest dose showing statistically insignificant reductions in hypoglycemia events versus placebo. Securities law firm Faruqi & Faruqi is investigating potential claims against the company on behalf of affected investors.

Rezolute's stock dropped 90% after its Phase 3 trial for ersodetug failed to meet primary and secondary endpoints in treating hypoglycemia caused by hyperinsulinism, prompting a shareholder investigation.

Additional $6.7M in funding resulting in approximately $67M in gross proceeds Additional $6.7M in funding resulting in approximately $67M in gross proceeds

NEW YORK, June 24, 2024 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT) (“Rezolute” or the “Company”), a late-stage biopharmaceutical company committed to developing novel, transformative therapies for serious rare diseases, today announced the closing of its underwritten public offering of 11,250,000 shares of its common stock at a price to the public of $4.00 per share and, to certain investors in lieu of common stock, pre-funded warrants to purchase 3,750,000 shares of its common stock at a price to the public of $3.999 per pre-funded warrant, in each case, before underwriting discounts and commissions. All of the shares and warrants in the public offering were sold by the Company.

NEW YORK, June 13, 2024 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT) (“Rezolute” or the “Company”), a late-stage biopharmaceutical company committed to developing novel, transformative therapies for serious rare diseases, today announced the pricing of its previously announced underwritten public offering of an aggregate of 11,250,000 shares of its common stock at an offering price of $4.00 per share, and, to certain investors in lieu of common stock, pre-funded warrants to purchase up to 3,750,000 shares of common stock at an offering price of $3.999 per pre-funded warrant, which represents the per share offering price for the common stock less the $0.001 per share exercise price for each pre-funded warrant. Gross proceeds from the underwritten public offering before deducting underwriting discounts and commissions and other offering expenses are expected to be approximately $60 million.

NEW YORK, June 13, 2024 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT) (“Rezolute” or the “Company”), a late-stage biopharmaceutical company committed to developing novel, transformative therapies for serious rare diseases, today announced that it is commencing an underwritten public offering of shares of its common stock (or pre-funded warrants to purchase its common stock in lieu thereof). In addition, the Company intends to grant the underwriters an option for a period of 30 days to purchase up to an additional 15 percent of the number of shares of its common stock plus the shares of common stock underlying pre-funded warrants sold in connection with the public offering. The public offering is subject to market and other conditions, and there can be no assurance as to whether or when the public offering may be completed or as to the actual size or terms of the public offering. All of the shares in the public offering are being offered by the Company.

Met primary study endpoints: good safety profile and reduction in central subfield thickness (CST)