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. (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.
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