Welcome to our dedicated page for Unicycive Therapeutics news (Ticker: UNCY), a resource for investors and traders seeking the latest updates and insights on Unicycive Therapeutics stock.
Unicycive Therapeutics Inc (UNCY) is a clinical-stage biotechnology company pioneering novel treatments for kidney diseases, including hyperphosphatemia and acute kidney injury. This page aggregates all corporate announcements, regulatory updates, and research milestones related to its innovative pipeline.
Investors and healthcare professionals will find timely updates on clinical trial progress, partnership developments, and financial disclosures. Our curated collection includes press releases about Renazorb (phosphate-binding therapy) and UNI-494 (acute kidney injury treatment), along with strategic business decisions impacting the company's trajectory.
Key content categories include FDA communications, peer-reviewed study publications, intellectual property updates, and earnings reports. All materials are sourced directly from official company channels to ensure accuracy and compliance with financial disclosure standards.
Bookmark this page for streamlined access to UNC's latest developments in renal therapeutics. Regularly updated to reflect new breakthroughs in drug development and corporate strategy, it serves as an essential resource for monitoring this innovative biotech's progress.
Unicycive Therapeutics (Nasdaq: UNCY) announced that two datasets showcasing the safety and potential efficacy of UNI-494 in animal models will be presented at the 60th European Renal Association Congress (ERA 2023) in Milan, Italy, from June 15-18, 2023. The presentations include one on UNI-494's impact on rat respiratory function and another detailing its effect on lowering urinary b2-microglobulin levels. CEO Shalabh Gupta expressed optimism regarding the drug's reno-protective capabilities, particularly for treating acute kidney injury (AKI), a condition lacking FDA-approved therapies. Additionally, the company is developing Renazorb, a phosphate binding agent, with plans to file a New Drug Application (NDA) mid-year.
Unicycive Therapeutics (Nasdaq: UNCY) announced a transformational $30 million financing, with an additional potential $100 million tied to milestones. This funding supports the commercialization of Renazorb™, a treatment for hyperphosphatemia. The company aims to file a New Drug Application with the FDA by mid-2023, targeting a 2024 launch. The global market for hyperphosphatemia treatment is projected at over $2.5 billion, with the U.S. contributing more than $1 billion. Despite recent losses totaling $18.1 million in 2022, the financing positions Unicycive strongly to drive awareness and growth in this market.
Unicycive Therapeutics (Nasdaq: UNCY) has secured a $30 million upfront private placement, with potential total funding reaching $130 million linked to milestone achievements. The financing, led by Vivo Capital, will support the New Drug Application (NDA) for its kidney disease treatment Renazorb, aimed at addressing the high pill burden faced by dialysis patients. Additionally, the company plans to implement a mandatory dividend policy post-profitability. Currently, Renazorb is positioned within a $2.5 billion market opportunity, with FDA filing expected mid-year 2023 following successful study results affirming its pharmaceutical equivalence to Fosrenol.
Unicycive Therapeutics (Nasdaq: UNCY) announced that its proprietary drug UNI-494, targeting acute and chronic kidney injury, will be featured in presentations at two conferences in March 2023. At the 5th Annual Chronic Kidney Disease Drug Development Summit, CEO Shalabh Gupta will discuss how mitochondria impact kidney disease progression. Additionally, two abstracts on UNI-494 will be presented at the 28th International Conference on Critical Care in Nephrology. The drug aims to restore mitochondrial function and is undergoing a Phase 1 clinical trial in the UK, with plans for a Phase 2 trial in AKI patients in the US later this year.
Unicycive Therapeutics (Nasdaq: UNCY) has secured an exclusive license agreement with Lotus Pharmaceutical for the development of Renazorb in South Korea, aimed at treating hyperphosphatemia in chronic kidney disease patients. This partnership is the second for Renazorb in Asia, emphasizing Unicycive's commitment to addressing patient needs. The deal entails a $750,000 upfront payment, with potential for up to $4.45 million in milestone payments and tiered royalties. Renazorb is designed to improve adherence among patients requiring phosphate binding treatments, a significant advantage given current compliance challenges in treatments for hyperphosphatemia.
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