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 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.
Rezolute (NASDAQ: RZLT) announced an inducement equity grant under Nasdaq Listing Rule 5635(c)(4) made as of September 30, 2025. The company granted options to purchase a total of 125,000 shares of common stock to two new employees.
The options carry a 10-year term, an exercise price of $9.40 per share (the closing price on September 30, 2025), and vest over four years subject to continued service. The awards were approved by the Compensation Committee as a material inducement to accept employment.
Rezolute (Nasdaq: RZLT) reported its Q4 and FY2025 financial results, highlighting significant progress in its hyperinsulinism treatment programs. The company completed enrollment for its Phase 3 sunRIZE trial with 62 participants for congenital hyperinsulinism (HI), with topline results expected in December 2025. Additionally, Rezolute secured FDA alignment for a streamlined Phase 3 upLIFT study for tumor HI, requiring only 16 participants.
Financial highlights include cash position of $167.9M as of June 30, 2025, up from $127.1M year-over-year. R&D expenses increased to $61.5M for FY2025, while net loss widened to $74.4M. The company strengthened its leadership team with the appointment of Dr. Sunil Karnawat as Chief Commercial Officer, bringing extensive rare disease commercialization experience.
Rezolute (NASDAQ:RZLT) has secured FDA alignment for a streamlined Phase 3 trial design of ersodetug in tumor hyperinsulinism (HI). The agency approved significant modifications to the upLIFT study, eliminating the need for a double-blind placebo-controlled trial and reducing the required participants to as few as 16 patients.
The study will now proceed as a single-arm open-label trial, with patient recruitment ongoing in the U.S. and Europe. The FDA will consider Rezolute's pivotal sunRIZE trial in congenital HI as confirmatory evidence, acknowledging ersodetug's broader applicability. Topline data is expected in the second half of 2026, while the sunRIZE trial results are anticipated in December 2025.
Rezolute (Nasdaq: RZLT), a late-stage rare disease company specializing in hypoglycemia treatment caused by hyperinsulinism, has announced its participation in three major upcoming investor conferences in September 2025.
The company will attend the Cantor Global Healthcare Conference (September 3-5), the H.C. Wainwright Global Investment Conference (September 8-10), and the Morgan Stanley Global Healthcare Conference (September 8-10). Management will engage in Fireside Chats and one-on-one meetings with investors during these events.
FAQ
What is the current stock price of Rezolute (RZLT)?
What is the market cap of Rezolute (RZLT)?
