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Investing.com - H.C. Wainwright has reiterated a Buy rating and $14.00 price target on Rezolute (NASDAQ:RZLT), currently trading at $7.17, following the FDA’s approval of a streamlined Phase 3 upLIFT study for ersodetug. According to InvestingPro data, analyst targets range from $9 to $17, with a strong consensus Buy recommendation.
The FDA’s decision allows Rezolute to conduct a single-arm, open-label registrational study in up to 16 patients with tumor hyperinsulinism (HI), rather than the originally proposed double-blind, randomized study that would have required up to 48 patients.
This regulatory development follows the FDA granting two Breakthrough Therapy Designations (BTD) for ersodetug this year, which H.C. Wainwright views as recognition of the drug’s value in treating HI, a rare disease. The market has responded positively, with InvestingPro data showing the stock has gained over 73% in the past six months.
The research firm believes the FDA’s decision was partially influenced by real-world evidence of ersodetug’s effectiveness in over 10 patients with tumor HI, aligning with FDA guidance on integrating real-world evidence in decision-making for rare diseases.
The simplified study design is expected to facilitate patient enrollment, as doctors and patients typically prefer assured access to the investigational drug rather than potentially receiving a placebo in a randomized trial. InvestingPro analysis shows the company maintains strong liquidity with a current ratio of 8.43, providing financial flexibility for its clinical programs. Discover more insights and 12 additional ProTips with an InvestingPro subscription.
In other recent news, Rezolute, Inc. has appointed Sunil Karnawat as Chief Commercial Officer, effective August 18, 2025. Karnawat brings over 25 years of experience in global commercialization, having previously held leadership roles at Cytokinetics and Ultragenyx. Additionally, Cantor Fitzgerald reiterated its Overweight rating on Rezolute’s stock, updating its financial model to reflect the company’s actual earnings from the second and third quarters of fiscal year 2025 and an April capital raise. Rezolute also announced the posting of a patient demographic poster for its ongoing Phase 3 sunRIZE study. This information was disclosed through a filing with the Securities and Exchange Commission and is available on the company’s website. These developments reflect the company’s ongoing efforts in clinical research and market positioning.
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