SCHEDULE 13G/A - Rezolute, Inc. (0001509261) (Subject)

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Ersodetug, a novel, fully human monoclonal antibody for the treatment of hyperinsulinism (HI), advancing in two late-stage, registrational clinical trials in two indications Phase 3 sunRIZE study on track; U.S. enrollment expected to commence in the first part of 2025 Phase 3 tumor HI study expected to commence in the first half of 2025 REDWOOD CITY, Calif., Nov. 07, 2024 (GLOBE NEWSWIRE) -- Rezolute, Inc. (NASDAQ:RZLT) ("Rezolute" or the "Company"), a late-stage biopharmaceutical company dedicated to developing transformative therapies for rare diseases with serious unmet needs, today reported financial results and provided a business update for the three months ended September 30, 202

REDWOOD CITY, Calif., Nov. 05, 2024 (GLOBE NEWSWIRE) -- Rezolute, Inc. (NASDAQ:RZLT) ("Rezolute" or the "Company"), a late-stage biopharmaceutical company dedicated to developing transformative therapies for rare diseases with serious unmet needs, today announced that management will participate in the following investor conferences: Event: Guggenheim's Innaugural Healthcare Innovation Conference Date: November 11-13, 2024 Event: Jefferies London Healthcare ConferenceDate: November 19-21, 2024 Management will be participating in one-on-one investor meetings throughout the conferences. Investors interested in scheduling a meeting with the Rezolute management team should contact their Gug

FDA lifts partial clinical holds on ersodetug for the treatment of congenital HI; Phase 3 sunRIZE study to proceed in the U.S. Phase 3 study for ersodetug for the treatment of tumor HI expected to commence in the first half of 2025 REDWOOD CITY, Calif., Sept. 19, 2024 (GLOBE NEWSWIRE) -- Rezolute, Inc. (NASDAQ:RZLT) ("Rezolute" or the "Company"), a late-stage biopharmaceutical company dedicated to developing transformative therapies for rare diseases with serious unmet needs, today reported financial results and provided a business update for the fourth quarter and full fiscal year ended June 30, 2024. "We are thrilled to close out the year with FDA alignment to advance ersodetug in two

REDWOOD CITY, Calif., Sept. 09, 2024 (GLOBE NEWSWIRE) -- Rezolute, Inc. (NASDAQ:RZLT) ("Rezolute" or the "Company"), a late-stage rare disease company developing a novel therapy to treat hyperinsulinism (HI), today announced that the U.S. Food and Drug Administration (FDA) has removed the partial clinical holds on RZ358 (ersodetug), a potential treatment for hypoglycemia caused by congenital HI. Ersodetug is currently being studied in sunRIZE, a global Phase 3, multi-center, double-blind, randomized, placebo-controlled, safety and efficacy registrational study in participants with congenital HI. The Company will now commence study start-up activities in the U.S. with the goal of includi

REDWOOD CITY, Calif., Aug. 27, 2024 (GLOBE NEWSWIRE) -- Rezolute, Inc. (NASDAQ:RZLT) ("Rezolute" or the "Company"), a late-stage rare disease company focused on significantly improving outcomes for individuals with hypoglycemia caused by hyperinsulinism (HI), today announced that management will participate in the following investor conferences: Event: H.C. Wainwright 26th Annual Global Investment ConferenceDate: September 9-11, 2024 Event: Cantor Global Healthcare ConferenceDate: September 17-19, 2024 Management will be participating in one-on-one investor meetings throughout the conferences. Investors interested in scheduling a meeting with the Rezolute management team should contact

Second rare disease program with RZ358 in Phase 3 development Follows successful treatment of multiple patients with tumor hyperinsulinism under the Company's Expanded Access Program REDWOOD CITY, Calif., Aug. 05, 2024 (GLOBE NEWSWIRE) -- Rezolute, Inc. (NASDAQ:RZLT) ("Rezolute" or the "Company"), a late-stage biopharmaceutical company committed to developing novel, transformative therapies for serious rare diseases, today announced that it received U.S. Food and Drug Administration (FDA) clearance for its Investigational New Drug (IND) application for RZ358 (ersodetug) to treat hypoglycemia in patients with tumor hyperinsulinism (HI). The Company is initiating start-up activities for th

REDWOOD CITY, Calif., July 31, 2024 (GLOBE NEWSWIRE) -- Rezolute, Inc. (NASDAQ:RZLT) ("Rezolute" or the "Company"), a late-stage biopharmaceutical company committed to developing novel, transformative therapies for serious rare diseases, today announced that Nevan Charles Elam, Chief Executive Officer and Founder of Rezolute, will participate in a fireside chat during the BTIG Virtual Biotechnology Conference on Monday, August 5, 2024, at 12:00 p.m. ET. Management will be participating in one-on-one investor meetings throughout the conference. Investors interested in scheduling a meeting with the Rezolute management team should contact their BTIG representative. About Rezolute, Inc. Rez

NEW YORK, June 27, 2024 (GLOBE NEWSWIRE) -- Rezolute, Inc. (NASDAQ:RZLT) ("Rezolute" or the "Company"), a late-stage biopharmaceutical company committed to developing novel, transformative therapies for serious rare diseases, today announced that the underwriters of its previously announced public offering, which closed on June 24, 2024, have exercised an over-allotment option to purchase an additional 1,786,589 shares of the Company's common stock at the public offering price of $4.00 per share, less underwriting discounts and commissions. After giving effect to the option closing, the total number of shares sold by the Company in the offering were 13,036,589 shares, which along with pre-

NEW YORK, June 24, 2024 (GLOBE NEWSWIRE) -- Rezolute, Inc. (NASDAQ:RZLT) ("Rezolute" or the "Company"), a late-stage biopharmaceutical company committed to developing novel, transformative therapies for serious rare diseases, today announced the closing of its underwritten public offering of 11,250,000 shares of its common stock at a price to the public of $4.00 per share and, to certain investors in lieu of common stock, pre-funded warrants to purchase 3,750,000 shares of its common stock at a price to the public of $3.999 per pre-funded warrant, in each case, before underwriting discounts and commissions. All of the shares and warrants in the public offering were sold by the Company. Th

NEW YORK, June 13, 2024 (GLOBE NEWSWIRE) -- Rezolute, Inc. (NASDAQ:RZLT) ("Rezolute" or the "Company"), a late-stage biopharmaceutical company committed to developing novel, transformative therapies for serious rare diseases, today announced the pricing of its previously announced underwritten public offering of an aggregate of 11,250,000 shares of its common stock at an offering price of $4.00 per share, and, to certain investors in lieu of common stock, pre-funded warrants to purchase up to 3,750,000 shares of common stock at an offering price of $3.999 per pre-funded warrant, which represents the per share offering price for the common stock less the $0.001 per share exercise price for

REDWOOD CITY, Calif., Jan. 24, 2024 (GLOBE NEWSWIRE) -- Rezolute, Inc. (NASDAQ:RZLT), a clinical-stage biopharmaceutical company committed to developing novel, transformative therapies for serious metabolic and rare diseases, today announced the addition of Daron Evans, MS, MBA, to its leadership team as Chief Financial Officer as well as the grant of share options as a material inducement for his appointment (the "Inducement Grant"). About Mr. Evans "This is a pivotal year for Rezolute as we initiated our Phase 3 clinical study for RZ358 in congenital hyperinsulinism and anticipate reporting topline data from our Phase 2 study for RZ402 in diabetic macular edema in the secon

REDWOOD CITY, Calif., Aug. 10, 2021 (GLOBE NEWSWIRE) -- Rezolute, Inc. (NASDAQ:RZLT), a clinical-stage biopharmaceutical company developing transformative therapies for metabolic diseases associated with chronic glucose imbalance, today announced that the Company has initiated dosing in a Phase 1b multiple-ascending dose study of RZ402, Rezolute's investigational oral plasma kallikrein inhibitor (PKI) for the treatment of diabetic macular edema (DME). Rezolute also announced the appointment of ophthalmology expert and key opinion leader, Dr. Rajat Agrawal, MD, MS, as Vice President, Clinical Development to lead the RZ402 clinical development program. "The Phase 1b study will evaluate the

REDWOOD CITY, Calif., May 20, 2021 (GLOBE NEWSWIRE) -- Rezolute, Inc. (NASDAQ:RZLT), a clinical-stage biopharmaceutical company developing transformative therapies for metabolic diseases associated with chronic glucose imbalance, today announced the addition of Davelyn Hood, MD, to its leadership team as Director, Scientific and Patient Affairs. In her new role, Dr. Hood will be a key member of the team in furthering the development of RZ358, Rezolute's monoclonal antibody currently being evaluated in a Phase 2b clinical trial to treat congenital hyperinsulinism, a rare disease that is the most common cause of persistent low blood sugars in children. "Dr. Hood is an ideal addition to our

REDWOOD CITY, Calif., May 18, 2021 (GLOBE NEWSWIRE) -- Rezolute, Inc. (NASDAQ:RZLT), a clinical-stage biopharmaceutical company developing novel therapies for diseases related to chronic glucose imbalance, today announced the addition of Quan Dong Nguyen, MD, MSc, FAAO, FARVO to its Scientific Advisory Board. Dr. Nguyen is a renowned expert in retinal vascular and uveitic diseases and is expected to provide valuable strategic and scientific counsel related to RZ402, the Company's investigational oral plasma kallikrein inhibitor (PKI), for the treatment of diabetic macular edema (DME). "Dr. Quan Dong Nguyen has a distinguished track record of innovative research leading to new treatments f

REDWOOD CITY, Calif., Dec. 28, 2020 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq:RZLT), focused on advancing therapies for rare, metabolic and life-threatening diseases, announced today the appointment of IssuerDirect as the Company’s registrar and transfer agent and shareholder support provider. IssuerDirect will now be responsible for all transfers of Rezolute shares rather than VStock Transfer, LLC. Shareholders need take no action related to this transaction. About Rezolute, Inc.Rezolute is advancing targeted therapies for rare, metabolic, and life-threatening diseases. Its lead clinical asset, RZ358, is in Phase 2b development as a potential treatment for congenital HI, a rare pediatri

Wedbush initiated coverage of Rezolute with a rating of Outperform and set a new price target of $12.00

Guggenheim initiated coverage of Rezolute with a rating of Buy and set a new price target of $11.00

BTIG Research initiated coverage of Rezolute with a rating of Buy and set a new price target of $13.00

Craig Hallum initiated coverage of Rezolute with a rating of Buy and set a new price target of $14.00

Maxim Group initiated coverage of Rezolute with a rating of Buy and set a new price target of $8.00

Canaccord Genuity resumed coverage of Rezolute with a rating of Buy and set a new price target of $17.00

Cantor Fitzgerald initiated coverage of Rezolute with a rating of Overweight and set a new price target of $9.00

Canaccord Genuity reiterated coverage of Rezolute with a rating of Buy and set a new price target of $17.00 from $30.00 previously

JMP Securities reiterated coverage of Rezolute with a rating of Market Outperform and set a new price target of $18.00 from $30.00 previously

ROTH Capital initiated coverage of Rezolute with a rating of Buy and set a new price target of $21.00

Phase 3 clinical study of RZ358 underway in patients with congenital hyperinsulinism (cHI); topline results expected in mid-2025 Benefit shown in individual patient cases with RZ358 for tumor-associated hyperinsulinism (taHI) under Expanded Access Program (EAP); drives alignment with FDA on unmet need and potential to move into late-stage clinical development to further evaluate RZ358 in this population REDWOOD CITY, Calif., Feb. 13, 2024 (GLOBE NEWSWIRE) -- Rezolute, Inc. (NASDAQ:RZLT) ("Rezolute" or the "Company"), a clinical-stage biopharmaceutical company committed to developing novel, transformative therapies for serious metabolic and rare diseases, today announced its financial re

REDWOOD CITY, Calif., Nov. 13, 2023 (GLOBE NEWSWIRE) -- Rezolute, Inc. (NASDAQ:RZLT), a clinical-stage biopharmaceutical company committed to developing novel, transformative therapies for serious metabolic and rare diseases, today announced its financial results for the first quarter of fiscal 2024 ended September 30, 2023. "We are on track to commence our Phase 3 study for RZ358 to treat congenital hyperinsulinism prior to year-end and are delighted to have recently obtained PRIME eligibility from the European Medicines Agency for this indication," said Nevan Charles Elam, Chief Executive Officer and Founder of Rezolute. "We also anticipate completing enrollment this quarter for our o

REDWOOD CITY, Calif., Sept. 14, 2023 (GLOBE NEWSWIRE) -- Rezolute, Inc. (NASDAQ:RZLT), a clinical-stage biopharmaceutical company dedicated to developing transformative therapies with the potential to disrupt treatment paradigms for devastating metabolic diseases, today announced its financial results for the fourth quarter and full fiscal year ended June 30, 2023. "We are delighted that we are poised to initiate sunRIZE – our Phase 3 study of RZ358, which we hope will bring us one step closer to making this therapy available to patients and their families suffering from congenital hyperinsulinism. We are also anticipating results from our Phase 2 study of RZ402 in the first quarter of 20

Study to be initiated in Europe and other ex-US geographies in Q4 2023, with topline results expected 1H 2025 Conference call scheduled today at 4:30 p.m. ET  REDWOOD CITY, Calif., June 27, 2023 (GLOBE NEWSWIRE) -- Rezolute, Inc. (NASDAQ:RZLT), a clinical-stage biopharmaceutical company dedicated to developing transformative therapies with the potential to disrupt current treatment paradigms for devastating metabolic diseases, today provided an update on its clinical development plans for RZ358, the Company's product candidate for congenital hyperinsulinism (congenital HI). Rezolute plans to initiate sunRIZE, a pivotal Phase 3 clinical study of RZ358, in Europe and other geographies outs

REDWOOD CITY, Calif., May 11, 2023 (GLOBE NEWSWIRE) -- Rezolute, Inc. (NASDAQ:RZLT), a clinical-stage biopharmaceutical company dedicated to developing transformative therapies with the potential to shift the treatment paradigms of devastating metabolic diseases, today announced its financial results for the third quarter of fiscal 2023 ended March 31, 2023. "We are continuing to make progress across our pipeline, including preparation for a Phase 3 study for RZ358 as well as enrollment of patients in our Phase 2 study for RZ402," said Nevan Charles Elam, Chief Executive Officer and Founder of Rezolute. "The quarter was punctuated by a Rezolute-hosted virtual key opinion leader event th

REDWOOD CITY, Calif., March 08, 2023 (GLOBE NEWSWIRE) -- Rezolute, Inc. (NASDAQ:RZLT), a clinical-stage biopharmaceutical company dedicated to developing transformative therapies with the potential to transform the treatment paradigms of devastating metabolic diseases, will host a virtual event to highlight the Company's RZ402 Phase 2 clinical program and the rationale for an oral plasma kallikrein inhibitor (PKI) in diabetic macular edema (DME) on Wednesday, March 22, 2023, from 4:30 p.m. – 6:00 p.m. EDT. Rezolute management will be joined by Robert Bhisitkul, M.D., Ph.D., a practicing ophthalmologist and retina specialist at The University of California, San Francisco Medical Center. D

Initiated Phase 2 proof-of-concept study of RZ402 Anticipate initiation of global Phase 3 clinical study for RZ358 in mid 2023 REDWOOD CITY, Calif., Feb. 10, 2023 (GLOBE NEWSWIRE) -- Rezolute, Inc. (NASDAQ:RZLT), a clinical-stage biopharmaceutical company dedicated to developing transformative therapies with the potential to transform the treatment paradigms of devastating metabolic diseases, today announced its financial results for the second quarter of fiscal 2023 ended December 31, 2022. "The past quarter was marked by steady execution across our pipeline as we continue to advance toward our goal of bringing transformative therapies to patients across the spectrum of metabolic disea

Phase 2 proof-of-concept study of RZ402 expected to be initiated by the end of this year REDWOOD CITY, Calif., Nov. 09, 2022 (GLOBE NEWSWIRE) -- Rezolute, Inc. (NASDAQ:RZLT), a clinical-stage biopharmaceutical company dedicated to developing transformative therapies with the potential to shift the treatment paradigms of devastating metabolic diseases, today announced its financial results for the first quarter of fiscal 2023 ended September 30, 2022. "I am extremely pleased with our progress this year, having reported positive data from both our clinical programs, Phase 1b study of RZ402 for Diabetic Macular Edema and Phase 2b study of RZ358 for Congenital Hyperinsulinism (HI), as well a

REDWOOD CITY, Calif., May 04, 2022 (GLOBE NEWSWIRE) -- Rezolute, Inc. (NASDAQ:RZLT), a clinical-stage biopharmaceutical company dedicated to developing transformative therapies with the potential to disrupt current treatment paradigms for devastating metabolic diseases, today announced that management will be hosting a corporate update call. The call will highlight recent pipeline advancements and continued activities for the development of RZ358 for Congenital Hyperinsulinism and RZ402 for Diabetic Macular Edema. Conference Call and Webcast Information Rezolute management will host a conference call at 4:30 p.m. ET on Wednesday, May 4, 2022. Analysts and investors are invited to partici

Highly significant ~75% reduction in hypoglycemia events at anticipated therapeutic doses≥50% improvement in hypoglycemia in 100% of patients in high-dose cohort, with no adverse drug reactions or clinically significant hyperglycemiaStudy exceeded expectations for correction of hypoglycemia across multiple metrics, including hypoglycemia events and time in hypoglycemiaPredictable and dose-dependent exposures with a clear dose-responseGood safety and tolerability across all doses with no study discontinuations or adverse drug reactions Results are Phase 3 enabling and demonstrate the potential for RZ358 to be used as a monotherapy as well as a potential universal therapy for all forms of hype

BTIG analyst Julian Harrison initiates coverage on Rezolute (NASDAQ:RZLT) with a Buy rating and announces Price Target of $13.

Shares of AMMO, Inc. (NASDAQ:POWW) fell sharply during Friday's session following fourth-quarter results. AMMO reported a fourth-quarter profit of 1 cent per share, compared to market expectations for a loss of 1 cent per share. The company reported quarterly sales of $40.42 million topping estimates of $37.90 million, according to data from Benzinga Pro. AMMO shares dipped 19.1% to $2.0306 on Friday. Here are some other stocks moving in today’s mid-day session. Gainers Kaival Brands Innovations Group, Inc. (NASDAQ:KAVL) shares jumped 345% to $6.06. SRIVARU Holding Limited (NASDAQ:SVMH) gained 150% to $0.3852 after the company announced it will begin accepting paid reserva

Gainers Cyclerion Therapeutics (NASDAQ:CYCN) shares moved upwards by 37.4% to $2.9 during Friday's regular session. The market value of their outstanding shares is at $7.2 million. CNS Pharma (NASDAQ:CNSP) stock rose 35.86% to $4.92. The market value of their outstanding shares is at $1.9 million. Longeveron (NASDAQ:LGVN) shares moved upwards by 23.23% to $3.31. The market value of their outstanding shares is at $21.0 million. iSpecimen (NASDAQ:ISPC) stock moved upwards by 19.44% to $0.49. The market value of their outstanding shares is at $4.8 million. Scinai Immunotherapeutics (NASDAQ:SCNI) stock rose 17.8% to $3.32. The market value of their outstanding shares is at $1.9 million. Di

Shares of Adobe Inc. (NASDAQ:ADBE) rose sharply in today's pre-market trading following better-than-expected second-quarter earnings and strong guidance. Adobe reported second-quarter revenue of $5.31 billion, beating the consensus estimate of $5.292 billion. The company reported quarterly adjusted earnings of $4.48 per share, beating analyst estimates of $4.39 per share, according to data from Benzinga Pro. Adobe shares surged 14.6% to $525.76 in the pre-market trading session. Here are some other stocks moving in pre-market trading. Gainers FOXO Technologies Inc. (NYSE:FOXO) rose 53.7% to $0.3674 in pre-market trading. Chijet Motor Company, Inc. (NASDAQ:CJET) shares rose

Gainers Ainos (NASDAQ:AIMD) stock rose 54.8% to $1.27 during Friday's pre-market session. The market value of their outstanding shares is at $8.2 million. Longeveron (NASDAQ:LGVN) shares moved upwards by 34.15% to $3.61. The company's market cap stands at $22.9 million. Bio-Path Hldgs (NASDAQ:BPTH) shares increased by 20.99% to $2.42. The market value of their outstanding shares is at $4.4 million. Moleculin Biotech (NASDAQ:MBRX) stock moved upwards by 17.24% to $5.1. The market value of their outstanding shares is at $11.7 million. Tonix Pharmaceuticals (NASDAQ:TNXP) shares moved upwards by 12.84% to $1.23. The company's market cap stands at $3.6 million. Molecular Partners (NASDAQ:MO

With U.S. stock futures trading mixed this morning on Friday, some of the stocks that may grab investor focus today are as follows: Adobe Inc. (NASDAQ:ADBE) posted upbeat results for its second quarter and also issued a strong forecast. The company said it expects full-year revenue to be between $21.4 billion and $21.5 billion versus estimates of $19.98 billion. Adobe sees full-year adjusted earnings in the range of $18 to $18.20 per share versus estimates of $16.78 per share, according to Benzinga Pro. Adobe shares jumped 14.8% to $527.55 in the after-hours trading session. Rezolute, Inc. (NASDAQ:RZLT) reported a proposed public offering of common stock and pre-funded warrants. Rezol

U.S. stock futures were lower this morning, with the Dow futures falling around 250 points on Friday. Shares of RH (NYSE:RH) fell sharply in today's pre-market trading after the company reported mixed first-quarter financial results. RH reported quarterly losses of 40 cents per share which missed the analyst consensus estimate of losses of 12 cents per share. Quarterly sales came in at $726.96 million which beat the analyst consensus estimate of $724.7 million, according to data from Benzinga Pro. RH shares dipped 11.6% to $244.97 in pre-market trading. Here are some big stocks recording losses in today's pre-market trading session. Rezolute, Inc. (NASDAQ:RZLT) shares fell 19

Gainers Vaxart (NASDAQ:VXRT) shares increased by 146.7% to $1.85 during Thursday's after-market session. The market value of their outstanding shares is at $327.1 million. Venus Concept (NASDAQ:VERO) stock rose 10.32% to $0.95. The company's market cap stands at $6.0 million. Vincerx Pharma (NASDAQ:VINC) stock moved upwards by 5.99% to $0.73. The market value of their outstanding shares is at $21.5 million. Kintara Therapeutics (NASDAQ:KTRA) shares rose 5.82% to $0.2. The company's market cap stands at $10.9 million. Beyond Air (NASDAQ:XAIR) shares moved upwards by 5.64% to $1.31. The company's market cap stands at $60.1 million. Soligenix (NASDAQ:SNGX) stock rose 5.42% to $4.38. The m