Latest news with #Pediatric
Yahoo
20-05-2025
- Business
- Yahoo
Rezolute, Inc. (RZLT): Analysts See 260% Upside Potential
We recently published an article titled . Rezolute, Inc. (NASDAQ:RZLT) was one of the stocks that was covered in that article. Wall Street analysts believe RZLT has a 260% upside potential over the next 12 months. A scientist observing a microscope in a cutting edge biotechnology laboratory. Rezolute, Inc. (NASDAQ:RZLT) is a late-stage biopharmaceutical company focused on addressing rare diseases, particularly those involving hypoglycaemia caused by hyperinsulinism. Incorporated in 2010 and originally known as AntriaBio, Inc., it officially changed its name to Rezolute, Inc. in 2017. Rezolute's main product candidate, ersodetug (formerly known as RZ358), is a treatment for congenital hyperinsulinism (cHI), a rare genetic disorder in children, and is currently in Phase 3 clinical trials. The company is also working on RZ402, a pill that targets diabetic macular edema (DME), which is now undergoing Phase 2 testing. Rezolute, Inc.'s (NASDAQ:RZLT) unique value proposition lies in its development of ersodetug, a promising therapeutic option that aims to address rare diseases such as congenital hyperinsulinism. Unlike competitors who focus primarily on inhibiting insulin secretion, Rezolute's approach offers a potentially universal solution for these complex conditions. This strategic differentiation is further bolstered by regulatory advantages, including Orphan Drug and Rare Pediatric Disease designations, which underline its commitment to addressing unmet medical needs. Building on this momentum, Rezolute recently achieved a significant milestone when its Chief Medical Officer, Brian Roberts, announced the Independent Data Monitoring Committee's (DMC) favorable recommendation for continuing the Phase 3 sunRIZE study as planned. Roberts expressed optimism, stating: 'We are thrilled with the DMC's favorable recommendation, which appears to validate our initial assumptions for the design and powering of the Phase 3 sunRIZE study.' In terms of the company's financial standing, Rezolute has secured $120 million in financing, ensuring robust support for the late-stage development of RZ358, its lead candidate for congenital hyperinsulinism. This financial strength underscores its readiness to advance research and development efforts. With 70% of analysts assigning a buy rating to the stock and a consensus average price target of $13.44 for the next twelve months, Rezolute presents an upside potential of 260.32%. Overall, Rezolute, Inc. (NASDAQ:RZLT) ranks 11th on our list of 13 Best Multibagger Stocks to Invest in Now. While we acknowledge the potential of RZLT to grow, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and have limited downside risk. If you are looking for an AI stock that is more promising than RZLT and that has 100x upside potential, check out our report about this cheapest AI stock. READ NEXT: and Disclosure: None. This article is originally published at Insider Monkey. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
20-05-2025
- Business
- Yahoo
Rezolute, Inc. (RZLT): Analysts See 260% Upside Potential
We recently published an article titled . Rezolute, Inc. (NASDAQ:RZLT) was one of the stocks that was covered in that article. Wall Street analysts believe RZLT has a 260% upside potential over the next 12 months. A scientist observing a microscope in a cutting edge biotechnology laboratory. Rezolute, Inc. (NASDAQ:RZLT) is a late-stage biopharmaceutical company focused on addressing rare diseases, particularly those involving hypoglycaemia caused by hyperinsulinism. Incorporated in 2010 and originally known as AntriaBio, Inc., it officially changed its name to Rezolute, Inc. in 2017. Rezolute's main product candidate, ersodetug (formerly known as RZ358), is a treatment for congenital hyperinsulinism (cHI), a rare genetic disorder in children, and is currently in Phase 3 clinical trials. The company is also working on RZ402, a pill that targets diabetic macular edema (DME), which is now undergoing Phase 2 testing. Rezolute, Inc.'s (NASDAQ:RZLT) unique value proposition lies in its development of ersodetug, a promising therapeutic option that aims to address rare diseases such as congenital hyperinsulinism. Unlike competitors who focus primarily on inhibiting insulin secretion, Rezolute's approach offers a potentially universal solution for these complex conditions. This strategic differentiation is further bolstered by regulatory advantages, including Orphan Drug and Rare Pediatric Disease designations, which underline its commitment to addressing unmet medical needs. Building on this momentum, Rezolute recently achieved a significant milestone when its Chief Medical Officer, Brian Roberts, announced the Independent Data Monitoring Committee's (DMC) favorable recommendation for continuing the Phase 3 sunRIZE study as planned. Roberts expressed optimism, stating: 'We are thrilled with the DMC's favorable recommendation, which appears to validate our initial assumptions for the design and powering of the Phase 3 sunRIZE study.' In terms of the company's financial standing, Rezolute has secured $120 million in financing, ensuring robust support for the late-stage development of RZ358, its lead candidate for congenital hyperinsulinism. This financial strength underscores its readiness to advance research and development efforts. With 70% of analysts assigning a buy rating to the stock and a consensus average price target of $13.44 for the next twelve months, Rezolute presents an upside potential of 260.32%. Overall, Rezolute, Inc. (NASDAQ:RZLT) ranks 11th on our list of 13 Best Multibagger Stocks to Invest in Now. While we acknowledge the potential of RZLT to grow, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and have limited downside risk. If you are looking for an AI stock that is more promising than RZLT and that has 100x upside potential, check out our report about this cheapest AI stock. READ NEXT: and Disclosure: None. This article is originally published at Insider Monkey. Sign in to access your portfolio
Yahoo
28-01-2025
- Business
- Yahoo
SEED Receives FDA Rare Pediatric Disease and Orphan Drug Designations for Lead Oncology Asset RBM39 Degrader and Enters Strategic Transactions with New Investors
KING OF PRUSSIA, Pa., Jan. 28, 2025 (GLOBE NEWSWIRE) -- SEED Therapeutics Inc. ('SEED'), a biotechnology company pioneering the discovery of molecular glues for targeted protein degradation (TPD) using its proprietary RITE3™ platform, today announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease and Orphan Drug designations to SEED's ST-01156 molecular glue. This novel agent degrades RBM39, an RNA splicing factor implicated in multiple mechanism-targeted solid tumor indications. SEED is advancing ST-01156 toward an Investigational New Drug (IND) application, with an expected IND filing in the first half of 2025. The Rare Pediatric Disease designation positions SEED to potentially receive an FDA priority review voucher upon approval of ST-01156. SEED also announced that its largest shareholder, BeyondSpring Inc. (NASDAQ: BYSI) ('BeyondSpring'), has entered into definitive agreements to sell a portion of its Series A-1 Preferred Shares of SEED. Upon completion of the transactions, BeyondSpring is expected to retain approximately 14.4% of SEED's outstanding shares. Pioneering Progress in Targeted Protein Degradation'SEED is rapidly transitioning into a clinical-stage company, with the planned IND filing in the next few months for ST-01156, our novel and potentially best-in-class RBM39 degrader. This marks a significant milestone in our four-year journey to bring innovative therapies to patients,' said Dr. Lan Huang, Co-Founder, Chairman, and CEO of SEED and BeyondSpring. 'RBM39 is a validated target to address cancers with high unmet medical needs, as highlighted in a recent Nature Reviews Drug Discovery article. At SEED, we are committed to improving patient outcomes through pioneering science and rational drug development.' FDA Recognition and Strategic Growth'The FDA's Rare Pediatric Disease and Orphan Drug designations for ST-01156 represent an important milestone, recognizing its potential to address significant unmet needs in rare oncology indications,' said Jackson Tai, Board Member of SEED. 'These designations may help expedite and reduce the cost of developing, approving, and commercializing this therapeutic agent.' Tai added: 'The transactions announced today will diversify SEED's shareholder base. We believe this is a key step in ensuring that our capital structure and ownership distribution align with institutional investor expectations. SEED is now better positioned to pursue key initiatives, including advancing its clinical pipeline, extending its capital markets options, and maintaining its leadership in the field of targeted protein degradation.' About SEED TherapeuticsSEED Therapeutics is an innovative biotech company focused on discovering and developing targeted protein degradation (TPD) therapeutics, with the mission to transform the treatment of diseases that currently have limited or no treatment options. Leveraging its cutting-edge RITE3™ platform, SEED is at the forefront of molecular glue-based TPD, addressing diseases in oncology and neurodegeneration. Through active collaborations with Eli Lilly and Company and Eisai Co., Ltd., and backed by a comprehensive intellectual property portfolio, SEED has built a robust pipeline of novel drug candidates now approaching clinical development. Visit to learn more. About BeyondSpringBeyondSpring is a global clinical-stage biopharmaceutical company advancing innovative therapies to improve clinical outcomes for patients with high unmet medical needs. BeyondSpring is advancing its first-in-class lead asset, Plinabulin, into late-stage clinical development as a direct anti-cancer agent in non-small cell lung cancer (NSCLC) and other cancer indications. Plinabulin binds to a differentiated pocket in tubulin, distinct from other tubulin binders, and is a potent inducer of dendritic cell maturation, which activates both adaptive and innate immunity. In combination with docetaxel, Plinabulin has demonstrated significant overall survival benefits compared to docetaxel alone in second- and third-line NSCLC with EGFR wild type (Lancet Respir Med 2024). Additionally, Plinabulin has shown a significant reduction in severe neutropenia across multiple clinical studies. BeyondSpring's pipeline also includes three preclinical immuno-oncology assets. Visit for more information. Investor Contact:IR@ Media Contact:PR@ in to access your portfolio
