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Unicycive Therapeutics, Inc. (NASDAQ: UNCY) is a biotechnology company committed to developing innovative treatments for kidney diseases with significant unmet medical needs. The company's primary focus lies in addressing hyperphosphatemia and acute kidney injury (AKI) through its advanced drug candidates: Renazorb and UNI-494.
Renazorb is a novel phosphate-binding agent under development for the treatment of hyperphosphatemia. Utilizing proprietary nanoparticle technology, Renazorb aims to reduce the pill burden for patients, thereby promising better adherence and compliance. Hyperphosphatemia, a common condition in patients with End Stage Renal Disease (ESRD), if left untreated, can lead to severe complications such as secondary hyperparathyroidism, renal osteodystrophy, and cardiovascular diseases. Despite the availability of several FDA-approved treatments, around 75% of U.S. dialysis patients fail to achieve target phosphorus levels. Renazorb has the potential to capture a significant share of the market, which exceeds $2.5 billion globally.
UNI-494 is another promising candidate, a novel nicotinamide ester derivative designed for the treatment of AKI. UNI-494 works by restoring mitochondrial function, a critical factor in kidney health. The drug is currently in Phase 1 dose-ranging safety studies in the United Kingdom, with completion expected in the second half of 2024. UNI-494 has been granted orphan drug designation by the U.S. FDA for the prevention of Delayed Graft Function (DGF) in kidney transplant patients. DGF is a serious complication following kidney transplantation, often requiring dialysis intervention during the first week post-transplant.
Unicycive recently received significant financial backing from leading healthcare investors, including Octagon Capital and Great Point Partners, LLC., in addition to support from existing investors like Logos Capital and Nantahala Capital. This funding will likely support the company's ongoing research and development efforts.
For the latest updates, Unicycive expects topline data from its clinical studies by the second quarter of 2024. This progress underscores Unicycive's commitment to delivering groundbreaking treatments for kidney disease patients worldwide.
For investor inquiries, please contact: ir@unicycive.com or call (650) 543-5470.
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.
Unicycive Therapeutics (Nasdaq: UNCY) announced the acceptance of three abstracts for presentation at the National Kidney Foundation's Spring Clinical Meetings, scheduled for April 11-15, 2023, in Austin, Texas. These abstracts highlight key findings involving UNI-494 and its potential for treating acute kidney disease, along with efficacy data underscoring Renazorb’s benefits as a phosphate binder for hyperphosphatemia. CEO Shalabh Gupta expressed optimism regarding the evidence supporting both products, particularly noting an upcoming FDA New Drug Application submission for Renazorb in mid-2023, enhancing its profile for chronic kidney disease patients.
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