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Rezolute, Inc. - RZLT STOCK NEWS

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 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.

News

Rezolute Receives Innovation Passport Designation from the U.K. Innovative Licensing and Access Pathway Steering Group for RZ358 in the Treatment of Hypoglycemia Due to Congenital Hyperinsulinism

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Rezolute, Inc. (Nasdaq: RZLT) has received the Innovation Passport designation from the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) for their drug RZ358, intended for the treatment of hypoglycemia due to congenital hyperinsulinism (HI). This designation was granted based on the significant unmet medical need in this condition and the potential for RZ358 to benefit patients, as evidenced by the Phase 2 RIZE study. The Innovation Passport is the first step in the Innovative Licensing and Access Pathway (ILAP) and aims to accelerate the time to market and facilitate patient access to medicines. Rezolute is enthusiastic about the potential to bring this therapy to patients in need.
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Rezolute Initiates Phase 3 Clinical Study for RZ358 in Congenital Hyperinsulinism

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Rezolute, Inc. (Nasdaq: RZLT) has initiated sunRIZE, a pivotal Phase 3 clinical study of RZ358 in patients with congenital hyperinsulinism (cHI), with enrollment expected to be completed by the end of 2024 and topline results reported in mid-year 2025. The Phase 3 study follows the successful Phase 2 trial, demonstrating promising results in treating cHI. The company has received a priority medicines (PRIME) designation of RZ358 for the treatment of cHI from the European Medicines Agency. The study will enroll up to 56 participants and be conducted at approximately 20 expert centers in more than a dozen countries around the world.
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Rezolute Completes Enrollment of its Phase 2 Study in Diabetic Macular Edema (“DME”)

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Rezolute, Inc. (Nasdaq: RZLT) completes enrollment in RZ402 Phase 2 study for diabetic macular edema, expects to report topline data in mid-second quarter 2024.
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Stonegate Healthcare Partners Announces Black Friday Biotech Special Report For an "XBI-MAS"

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Stonegate Healthcare Partners (Ticker: RZLT) presents 'Black Friday Biotech Sale: 12 Stocks for XBI-MAS' report, highlighting a unique opportunity in the biotech sector. The report showcases a carefully curated shopping list of top 1% publicly traded biotech companies with institutional support, robust pipelines, upcoming milestones, and strong management teams. Key takeaways include the significant decline in biotech stocks, with the XBI biotech index 56% lower than its 5-year high, and 30% of NASDAQ-listed biotech companies trading at negative enterprise value.
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Rezolute to Participate in BTIG’s 3rd Annual Ophthalmology Day

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Rezolute, Inc. (Nasdaq: RZLT) to participate in BTIG’s 3rd Annual Ophthalmology Day, discussing RZ402, an oral plasma kallikrein inhibitor for diabetic macular edema. Investor meetings to be held on November 27th.
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Rezolute Reports First Quarter Fiscal 2024 Results

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Rezolute, Inc. (Nasdaq: RZLT) announced its financial results for the first quarter of fiscal 2024, showing a total of $106.9 million in cash, cash equivalents, and investments in marketable debt securities. The company is on track to commence its Phase 3 study for RZ358 to treat congenital hyperinsulinism and has obtained PRIME eligibility from the European Medicines Agency for this indication. They also anticipate completing enrollment this quarter for their ongoing Phase 2 study of RZ402 for the treatment of diabetic macular edema.
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Rezolute Receives Priority Medicines (PRIME) Eligibility from European Medicines Agency for Enhanced Regulatory Support of RZ358 in Congenital Hyperinsulinism

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Rezolute, Inc. has received PRIME eligibility from the European Medicines Agency for its drug candidate RZ358, which is being developed for the treatment of congenital hyperinsulinism. The EMA has recognized the unmet medical need for this condition and the potential benefits of RZ358 for patients. This eligibility was granted based on positive data from the Phase 2b RIZE study, which showed significant improvements in hypoglycemia events and time.
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Rezolute Announces Further Evidence of RZ358’s Efficacy in Tumor-Mediated Hyperinsulinism

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Rezolute announces positive results of RZ358 treatment for refractory hypoglycemia in patients with tumor-mediated hyperinsulinism
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Rezolute Reports Full Year Fiscal 2023 Results and Highlights Company Progress

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Rezolute, Inc. plans to initiate Phase 3 study for RZ358 in Q4 2023. Results expected in H1 2025. Phase 2 study of RZ402 to have results in Q1 2024. Cash and equivalents of $16.0M and investments of $102.3M as of June 30, 2023. R&D expenses increased from FY2022 to FY2023. Net loss increased from FY2022 to FY2023.
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Rezolute to Participate in Upcoming Investor Conferences in September

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Rezolute CEO to participate in investor conferences
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FAQ

What is the current stock price of Rezolute (RZLT)?

The current stock price of Rezolute (RZLT) is $4.39 as of December 20, 2024.

What is the market cap of Rezolute (RZLT)?

The market cap of Rezolute (RZLT) is approximately 253.7M.

What does Rezolute, Inc. specialize in?

Rezolute, Inc. specializes in developing innovative drug therapies for metabolic and orphan diseases.

What is RZ358?

RZ358 is a monoclonal antibody in Phase 2 clinical trials for treating congenital hyperinsulinism (CHI).

What stage is AB101 in?

AB101 is currently in Phase 1 clinical trials and is a once-weekly injectable basal insulin aimed at improving diabetes management.

What is RZ402?

RZ402 is a plasma kallikrein inhibitor targeting diabetic macular edema (DME), with plans to file an IND in H2 2018.

What designations has RZ358 received?

RZ358 has received Orphan Drug Designation in the U.S. and Europe, as well as PRIME designation by the European Medicines Agency.

When will Rezolute report topline data for their clinical trials?

Rezolute plans to report topline data by mid-second quarter 2024.

What makes Rezolute's therapies unique?

Rezolute applies proprietary formulation and manufacturing capabilities to well-characterized molecules, creating patent-protected therapies that improve existing standards of care.

What is the goal of AB101?

AB101 aims to transform diabetes management by reducing therapeutic burden and improving patient compliance.

What recent developments has Rezolute announced?

Rezolute plans to complete enrollment for ongoing studies by the end of 2024 and report topline results by mid-year 2025.

Where can I find more information about Rezolute, Inc.?

For more detailed information and latest updates, visit the company's official website at www.rezolutebio.com.

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Rezolute, Inc.

Nasdaq:RZLT

RZLT Rankings

#3662 Ranked by Market Cap
N/A Ranked by Dividends

RZLT Stock Data

253.74M
50.21M
13.74%
64.24%
2.05%
Biotechnology
Pharmaceutical Preparations
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