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Rezolute, Inc. (NASDAQ: RZLT) is a clinical-stage biopharmaceutical company focused on developing innovative drug therapies aimed at improving the lives of patients suffering from metabolic and orphan diseases. The company's core mission is to address significant unmet medical needs through a diversified pipeline of cutting-edge treatments.
One of Rezolute's most promising candidates is RZ358, currently in Phase 2 clinical trials. RZ358 is a monoclonal antibody designed for the treatment of congenital hyperinsulinism (CHI), an ultra-orphan condition. This drug has shown significant promise in improving hypoglycemia across multiple endpoints, with plans to report topline data by mid-second quarter 2024.
Another key asset is AB101, a once-weekly injectable basal insulin presently in Phase 1 trials. AB101 has the potential to revolutionize diabetes management by reducing the therapeutic burden on patients and enhancing compliance. Additionally, Rezolute is developing RZ402, a plasma kallikrein inhibitor targeting diabetic macular edema (DME), with plans to file an IND in the latter half of 2018.
Rezolute applies proprietary formulation and manufacturing capabilities to well-characterized molecules, creating differentiated, patent-protected therapies. This approach not only improves existing standards of care but also offers significant commercial potential. The company has received multiple designations for its products, including Orphan Drug Designation for RZ358 in the U.S. and Europe, and PRIME designation by the European Medicines Agency.
Recent developments include plans to complete enrollment for ongoing studies by the end of 2024 and to report topline results by mid-year 2025. These milestones underline Rezolute's commitment to advancing its clinical programs and bringing transformative therapies to market.
For more detailed information and latest updates, visit the company's official website at www.rezolutebio.com.
Rezolute (NASDAQ: RZLT) reported Q2 FY2025 financial results and business updates. The company's lead drug ersodetug received Breakthrough Therapy Designation and Orphan Drug Designation for hyperinsulinism (HI) treatment. A Data Monitoring Committee reviewed the open-label arm of the sunRIZE study, confirming safe drug concentrations in infant participants.
Financial highlights: Cash position at $105.3 million as of December 31, 2024, down from $127.1 million in June 2024. Q2 R&D expenses increased to $12.6 million from $12.0 million year-over-year. G&A expenses rose to $4.5 million from $3.2 million. Net loss widened to $15.7 million from $13.9 million.
Key milestones: Phase 3 sunRIZE study enrollment expected to conclude in Q2 2025, with topline results in Q4 2025. A Phase 3 study for tumor HI is planned to begin in H1 2025, with results expected in H2 2026.
Rezolute (NASDAQ: RZLT) announced key updates for its Phase 3 sunRIZE study of ersodetug, treating hypoglycemia due to congenital hyperinsulinism. The Data Monitoring Committee (DMC) reviewed the open-label arm involving 8 infant participants aged 3 months to 1 year, confirming that target drug concentrations were safely achieved at tested doses of 5 or 10 mg/kg.
Key findings show ersodetug was generally safe and well-tolerated in infants, with drug levels comparable to effective exposures in older pediatric participants from the Phase 2b RIZE study. The DMC approved infant enrollment in the double-blind portion of the study.
Study enrollment completion is expected in Q2 2025, with topline results in Q4 2025, subject to an upcoming interim analysis. The interim analysis, scheduled for early Q2 2025, could recommend continuing the study as planned, increasing the sample size by 33%, or stopping for futility. If expanded, enrollment would extend to Q4 2025 with results by mid-2026.
Rezolute (Nasdaq: RZLT), a late-stage biopharmaceutical company focused on developing transformative therapies for rare diseases, has announced its participation in the Guggenheim SMID Cap Biotech Conference. The conference is scheduled for February 5-6, 2025, in New York City.
The company's management team will be available for one-on-one meetings with investors throughout the conference. Interested investors can arrange meetings through their Guggenheim representatives.
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.
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