Rezolute Inc Stock Price, News & Analysis

Rezolute (Nasdaq: RZLT), a late-stage biopharmaceutical company, announced that the FDA granted Breakthrough Therapy Designation to ersodetug (RZ358) for treating hypoglycemia due to congenital hyperinsulinism (HI). This designation, aimed at expediting the development of treatments for serious conditions, is based on Phase 2b (RIZE) study results showing significant hypoglycemia improvement of 75% or better without clinically significant hyperglycemia.

CEO Nevan Charles Elam highlighted 2024 as a transformative year with key clinical milestones. The company plans to finish recruitment for the sunRIZE study and announce topline results in the second half of the year. Additionally, Phase 3 study for tumor HI is set to commence.

Key highlights from 2024:

• FDA lifted partial clinical holds on the Phase 3 sunRIZE study, enabling U.S. site inclusion.
• Received Innovation Passport Designation from the U.K. for congenital HI treatment.
• Preclinical validation for treating hypoglycemia due to non-islet cell tumors (NICTs).
• FDA clearance for a Phase 3 study for tumor HI, with topline results expected in 2026.
• Received Orphan Drug Designation for tumor HI.
• Raised $73 million in June to support clinical programs and operational goals into Q2 2026.

Rezolute (Nasdaq: RZLT), a late-stage biopharmaceutical company focused on rare disease therapies, announced the approval of an inducement award of 150,000 shares of common stock to its new Senior Vice President of Global Product Supply. The award, granted under Nasdaq Rule 5635(c)(4) on November 30, 2024, was priced at the company's closing price on November 29, 2024. The shares will vest 25% after one year of employment, followed by monthly vesting over the subsequent 36 months.

Rezolute (Nasdaq: RZLT) announced that the FDA has granted Orphan Drug Designation to ersodetug for treating hypoglycemia due to tumor hyperinsulinism (HI). The company plans to initiate a Phase 3 registrational trial for ersodetug in tumor HI patients in 2025. The FDA's designation offers seven years of market exclusivity and potential expedited approval pathways. Ersodetug aims to provide a universal treatment for hypoglycemia caused by all forms of HI, addressing a serious unmet medical need and enabling patients to continue cancer treatments while managing hypoglycemia.

Rezolute reported Q1 fiscal 2025 financial results and provided updates on its ersodetug clinical trials for hyperinsulinism (HI). The company is advancing two Phase 3 trials: the sunRIZE study for congenital HI, with U.S. enrollment starting in early 2025, and a tumor HI study commencing in H1 2025. Financial highlights include cash position of $117.8 million as of September 30, 2024, R&D expenses of $12.8 million, and a net loss of $15.4 million. Topline results are expected in H2 2025 for sunRIZE and H2 2026 for the tumor HI study.

Rezolute (Nasdaq: RZLT), a late-stage biopharmaceutical company focused on developing transformative therapies for rare diseases, has announced its participation in two upcoming investor conferences. The company will attend Guggenheim's Inaugural Healthcare Innovation Conference from November 11-13, 2024, and the Jefferies London Healthcare Conference from November 19-21, 2024.

Management will be available for one-on-one meetings with investors during both conferences. Interested investors can schedule meetings through their Guggenheim and Jefferies representatives.

Rezolute, Inc. (Nasdaq: RZLT) reported its Q4 and full fiscal year 2024 financial results and provided a business update. Key highlights include:

1. FDA lifted partial clinical holds on ersodetug for congenital HI treatment; Phase 3 sunRIZE study to proceed in the U.S.

2. Phase 3 study for ersodetug in tumor HI expected to start in H1 2025.

3. Positive topline results from Phase 2 proof-of-concept study of RZ402 in DME patients.

4. Cash, cash equivalents, and investments were $127.1 million as of June 30, 2024.

5. Full fiscal year 2024 R&D expenses increased to $55.7 million from $43.8 million in 2023.

6. Full fiscal year 2024 net loss was $68.5 million compared to $51.8 million in 2023.

Rezolute, Inc. (Nasdaq: RZLT) announced that the FDA has lifted partial clinical holds on RZ358 (ersodetug), their potential treatment for hypoglycemia caused by congenital hyperinsulinism (HI). This allows the company to include U.S. participants in their ongoing global Phase 3 sunRIZE study. Rezolute plans to begin U.S. enrollment in early 2025, aiming to announce topline data in the second half of 2025. The FDA concluded that liver toxicity observed in rats is likely strain-specific and not relevant to humans. This development follows FDA clearance for a separate Phase 3 study in tumor-associated HI, positioning Rezolute to advance two Phase 3 rare disease programs globally.

Rezolute, Inc. (Nasdaq: RZLT), a late-stage rare disease company focusing on improving outcomes for individuals with hypoglycemia caused by hyperinsulinism (HI), has announced its participation in two upcoming investor conferences. The company will attend the H.C. Wainwright 26th Annual Global Investment Conference from September 9-11, 2024, and the Cantor Global Healthcare Conference from September 17-19, 2024.

During these events, Rezolute's management team will be available for one-on-one meetings with investors. Interested parties are encouraged to contact their H.C. Wainwright and Cantor representatives to schedule meetings. This participation provides an opportunity for investors to gain insights into Rezolute's progress in addressing rare diseases, particularly its work on hypoglycemia caused by hyperinsulinism.

Rezolute (Nasdaq: RZLT) has received FDA clearance for its IND application for RZ358 (ersodetug) to treat hypoglycemia in patients with tumor hyperinsulinism (HI). This marks the company's second rare disease program with RZ358 in Phase 3 development. The study will primarily be conducted in the U.S., with patient enrollment planned for the first half of 2025.

The Phase 3 registrational study is a double-blind, randomized, placebo-controlled trial involving 24 participants with inadequately controlled hypoglycemia due to tumor HI. The primary endpoint is the change in Level 2 and Level 3 hypoglycemia events. Ersodetug is a fully human monoclonal antibody that binds to an allosteric site on the insulin receptor, potentially offering a universal treatment for hypoglycemia caused by all forms of HI.