Hagens Berman and Pomerantz Launch Probes Into Rezolute After Phase 3 Ersodetug Failure

Overview

• Rezolute reported on December 11 that the Phase 3 sunRIZE study in congenital hyperinsulinism failed its primary endpoint and a key secondary endpoint.
• Topline data showed about a 45% reduction in hypoglycemia events at the 10 mg/kg dose versus roughly 40% in placebo and a ~25% reduction in CGM time-in-hypoglycemia versus a ~5% increase on placebo, with neither difference statistically significant.
• Rezolute shares fell as much as about 90% intraday on the results and later closed at $1.77 on December 19, down 87% from prior levels.
• Hagens Berman opened an investigation into potential investor misrepresentation, urging shareholders to submit losses and inviting whistleblower tips under the SEC program.
• Pomerantz separately announced an investigation into possible securities-law violations, citing recent company statements that described ersodetug as poised to demonstrate efficacy and capable of substantially eradicating hypoglycemia.