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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.

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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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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.

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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.

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Rezolute (Nasdaq: RZLT), a late-stage biopharmaceutical company focused on developing novel therapies for rare diseases, has announced its participation in the BTIG Virtual Biotechnology Conference. The company's CEO and Founder, Nevan Charles Elam, will engage in a fireside chat on August 5, 2024, at 12:00 p.m. ET.

The Rezolute management team will also be available for one-on-one investor meetings throughout the conference. Interested investors are encouraged to contact their BTIG representative to schedule a meeting. This event provides an opportunity for Rezolute to showcase its progress in developing transformative therapies and engage with potential investors.

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Rezolute announced the exercise of underwriters’ option to purchase an additional 1,786,589 shares at $4.00 per share, generating $6.7M in funding. This increases the total gross proceeds from the public offering to approximately $67M. The offering closed on June 24, 2024, with Rezolute selling 13,036,589 shares alongside pre-funded warrants for 3,750,000 shares. Additionally, Rezolute has a concurrent private placement of 1,500,000 shares at $4.00 per share. Jefferies and Cantor served as joint book-running managers, with BTIG, Craig-Hallum, H.C. Wainwright & Co., Jones, and Maxim Group as co-managers.

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Rezolute, a late-stage biopharmaceutical company, announced the successful closure of its public offering, generating approximately $60 million in gross proceeds. The offering included 11.25 million shares of common stock at $4.00 per share and 3.75 million pre-funded warrants for $3.999 each. The company netted roughly $56.4 million after deducting underwriting discounts and commissions. The funds will support general corporate activities, post-Phase 3 preparation for the RZ358 program targeting congenital hyperinsulinism (cHI), and a potential late-stage clinical study of RZ358 for tumor hyperinsulinism (tHI) linked to islet and non-islet cell tumors.

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Rezolute announced the pricing of a public offering worth $60 million, involving 11,250,000 common stock shares priced at $4.00 each and pre-funded warrants for 3,750,000 shares priced at $3.999 each. The offering is expected to close around June 17, 2024, pending customary conditions. Jefferies and Cantor are leading this offering, with BTIG, Craig-Hallum, H.C. Wainwright & Co., Jones and Maxim Group as co-managers. Gross proceeds are estimated at $60 million before any deductions. A shelf registration statement filed with the SEC on November 29, 2023, supports this offering. Rezolute is focused on developing treatments for hyperinsulinism.

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Rezolute, a late-stage biopharmaceutical company specializing in therapies for rare diseases, announced a proposed public offering of its common stock and pre-funded warrants. The company aims to grant underwriters a 30-day option to purchase an additional 15% of shares. This offering is subject to market conditions, and Jefferies and Cantor are managing the process. A shelf registration statement was filed with the SEC and declared effective on November 29, 2023. Copies of the prospectus supplement and accompanying prospectus will be available via the SEC's website and through Jefferies and Cantor Fitzgerald & Co.

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Rezolute (Nasdaq: RZLT) announced that its CEO, Nevan Charles Elam, will participate in a fireside chat at the Jefferies Global Healthcare Conference on June 6, 2024, at 1:00 p.m. ET in New York City. The event will feature a live webcast available on Rezolute's investor relations website, which will be archived for 90 days. Additionally, the management team will engage in one-on-one meetings with investors throughout the conference.

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Rezolute announced positive topline results from its Phase 2 study of RZ402 in Diabetic Macular Edema (DME) patients. The study met primary endpoints, showing a significant reduction in central subfield thickness (CST) and a good safety profile. This is the first oral therapy to demonstrate such effects, highlighting potential for early disease intervention. The study involved 94 participants and evaluated three dosages over 12 weeks. Results indicated a significant improvement in CST, especially at the 200 mg dose, with no severe adverse effects related to the drug. A virtual investor event will be held today at 5:30 pm ET to discuss these findings.

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FAQ

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

The current stock price of Rezolute (RZLT) is $4.99 as of September 17, 2024.

What is the market cap of Rezolute (RZLT)?

The market cap of Rezolute (RZLT) is approximately 280.7M.

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.

Rezolute, Inc.

Nasdaq:RZLT

RZLT Rankings

RZLT Stock Data

280.66M
55.36M
12.4%
77.25%
2.39%
Biotechnology
Pharmaceutical Preparations
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