Welcome to our dedicated page for Rezolute news (Ticker: RZLT), a resource for investors and traders seeking the latest updates and insights on Rezolute stock.
Rezolute, Inc. (Nasdaq: RZLT) is a late-stage rare disease company focused on treating hypoglycemia caused by hyperinsulinism (HI), including congenital and tumor forms of the condition. The RZLT news feed highlights company announcements, clinical trial updates, regulatory interactions and corporate developments related to its lead antibody therapy, ersodetug.
Investors and followers of Rezolute can use this page to review detailed updates on key Phase 3 programs such as the sunRIZE study in congenital hyperinsulinism and the upLIFT study in tumor hyperinsulinism. Company news has included topline results from sunRIZE, insights into pharmacologic activity and placebo effects in glucose endpoints, and plans to discuss the full dataset with the U.S. Food and Drug Administration under Breakthrough Therapy Designation.
News items also cover the evolution of the upLIFT trial design after alignment with the FDA on a streamlined, single-arm, open-label approach, as well as data from an Expanded Access Program in tumor HI that informed this strategy. In addition, Rezolute regularly reports on financial results, equity inducement grants under Nasdaq Listing Rule 5635(c)(4), participation in healthcare and investor conferences, and leadership appointments that support its development and potential commercialization plans for ersodetug.
By following RZLT news, readers can track how Rezolute communicates progress in its clinical programs, interprets study findings, and engages with regulators and the investment community. This page provides a centralized view of the company’s press releases and related disclosures, offering context for the ongoing development of ersodetug in rare hyperinsulinism indications.
Rezolute (Nasdaq: RZLT) reported outcomes from an FDA Type B meeting on March 17, 2026, for sunRIZE, a Phase 3 ersodetug study for congenital hyperinsulinism. The pivotal trial did not meet its primary endpoint versus placebo, though consistent CGM-based improvements and pharmacologic activity were observed.
FDA encouraged submission of full study reports and datasets for independent review and did not dismiss the program; Rezolute expects an update in the second half of 2026.
Rezolute (Nasdaq: RZLT) announced management will participate in the Citizens Life Sciences Conference on March 10-11, 2026 in Miami, FL.
Management plans one-on-one investor meetings throughout the conference; investors should contact their Citizens representative to schedule meetings with the Rezolute team.
Rezolute (Nasdaq: RZLT) reported Q2 fiscal 2026 results and a program update on Feb 12, 2026. The Phase 3 sunRIZE study of ersodetug in congenital hyperinsulinism did not meet its primary or key secondary endpoints, though some biomarker and CGM signals were observed.
The company achieved pharmacologic drug concentrations, all 59 completers entered the open‑label extension, and an FDA meeting under Breakthrough Therapy Designation is planned before end of Q1. Tumor HI upLIFT enrollment is ongoing with topline data expected H2 2026. Cash was $132.9M (Dec 31, 2025). Q2 net loss was $22.8M versus $15.7M year‑ago.
Rezolute (Nasdaq: RZLT) announced management will participate in the Guggenheim Emerging Outlook: Biotech Summit 2026 on February 11-12, 2026 in New York. Management will hold one-on-one investor meetings during the conference. Investors should contact their Guggenheim representative to schedule meetings.
Rezolute (Nasdaq: RZLT) reported Phase 3 sunRIZE results in congenital hyperinsulinism and shared Expanded Access Program (EAP) outcomes in tumor HI on Jan 7, 2026.
The company said sunRIZE did not meet its primary or key secondary endpoints but observed pharmacologic activity: target therapeutic concentrations in 5 mg/kg and 10 mg/kg arms and sensitive biomarker increases in circulating insulin. All 59 completers entered an open-label extension (OLE); 57 remain with exposures ~6 weeks to ~18 months.
In the EAP, 75% of patients on IV dextrose/TPN discontinued infusions. Rezolute plans FDA discussions in Q1 2026 and expects upLIFT topline results in H2 2026.
Rezolute (Nasdaq: RZLT) announced topline Phase 3 sunRIZE results in congenital hyperinsulinism on Dec 11, 2025. The study did not meet its primary endpoint assessing average weekly hypoglycemia events or its key secondary CGM endpoint.
At the top ersodetug dose (10 mg/kg) there was an approximate 45% reduction in hypoglycemia events versus a 40% improvement in placebo (not statistically significant). CGM time in hypoglycemia fell ~25% at 10 mg/kg versus a ~+5% increase with placebo. Target drug concentrations were achieved across ages. Safety was described as generally favorable; two participants had serious hypersensitivity leading to discontinuation. Rezolute intends to meet with FDA under its Breakthrough Therapy Designation; tumor HI study upLIFT topline expected H2 2026.
Rezolute (NASDAQ: RZLT) announced an inducement equity grant for two new employees, approved under Nasdaq Listing Rule 5635(c)(4).
The company granted options to purchase a total of 245,000 shares of common stock, with a 10-year term and an exercise price of $9.32 per share (closing price on October 31, 2025). The options vest over four years, subject to continued service.
Rezolute (Nasdaq: RZLT) reported first quarter fiscal 2026 results and a business update for the quarter ended September 30, 2025. The company said it remains on track to report topline Phase 3 sunRIZE results in December 2025 and that the FDA has aligned that sunRIZE meets registrational requirements for a BLA filing. For tumor hyperinsulinism, Rezolute said it achieved FDA alignment on a streamlined single-arm Phase 3 upLIFT study with enrollment underway and topline data expected in the second half of 2026. Financials: cash and investments were $152.2M at September 30, 2025; R&D expense was $13.1M; G&A was $6.7M; net loss was $18.2M.
Rezolute (Nasdaq: RZLT) will host a virtual investor event on Monday, November 10, 2025 from 12:00–1:30 pm EST to review the clinical development and market opportunity for ersodetug.
Management will discuss two Phase 3 programs: the sunRIZE study in congenital hyperinsulinism with topline results expected in December 2025, and the upLIFT study in tumor hyperinsulinism. The program discussion will include anticipated commercial opportunities and remarks from hyperinsulinism experts Mansa Krishnamurthy, MD, and Azeez Farooki, MD.
Investors can join via phone or the live webcast on Rezolute’s investor site; a replay will be available about two hours after the event.
Rezolute (Nasdaq: RZLT) announced management will participate in three investor conferences in late 2025: the Maxim Growth Summit on October 22-23, 2025, the Guggenheim 2nd Annual Healthcare Innovation Conference on November 10-12, 2025, and the Jefferies London Healthcare Conference on November 17-20, 2025.
Management expects to hold one-on-one investor meetings during the events. Investors who want to schedule meetings are instructed to contact their Maxim, Guggenheim, or Jefferies representative.