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) 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.
Unicycive Therapeutics (Nasdaq: UNCY) announced the acceptance of four abstracts for presentation at the World Congress of Nephrology 2023 in Bangkok from March 30 – April 2. Key presentations will include data on Renazorb's phosphate binding capabilities from a Phase 1 clinical study and preclinical assessments of UNI-494. The company is optimistic about filing a New Drug Application for Renazorb with the FDA mid-2023, which could enhance its market position and partnership opportunities.
Unicycive Therapeutics, Inc. (Nasdaq: UNCY) has announced the termination of its "at-the-market" equity offering program to mitigate shareholder dilution. The termination process begins immediately and will be finalized on January 8, 2023. The company has not conducted any sales under this offering since December 15, 2022. Unicycive is focused on developing therapies for kidney disease, including its lead drug, Renazorb, for hyperphosphatemia and UNI-494 for acute kidney injury. Additional details are available in the company's recent SEC filing.
Unicycive Therapeutics announced successful results from a pivotal bioequivalence study of Renazorb compared to Fosrenol, meeting the primary endpoint and establishing pharmacodynamic bioequivalence. This finding supports the upcoming New Drug Application submission scheduled for mid-2023. Renazorb, designed to treat hyperphosphatemia in chronic kidney disease patients, aims to reduce the pill burden, potentially improving patient compliance. The global market for hyperphosphatemia treatment exceeds $2.5 billion, with significant unmet needs in patient management.
Unicycive Therapeutics has received acceptance from the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) for its UNI-494 Phase 1 study, targeting patients with acute kidney injury. This first-in-human trial is set to begin in Q1 2023, following successful completion of preclinical safety assessments. UNI-494, which activates mitochondrial KATP channels, is supported by extensive safety data from earlier studies on its active metabolite, nicorandil. The company also plans to file an Investigational New Drug application with the FDA for a Phase 2 trial in 2023.
Unicycive Therapeutics, Inc. (NASDAQ:UNCY) will be featured in an interview on The RedChip Money Report® airing on Bloomberg TV on December 10, 2022, at 7 p.m. ET. CEO Shalabh Gupta will discuss key developments, including data from the upcoming bioequivalence study and the forthcoming Phase 1 trial for the company’s lead program targeting hyperphosphatemia. The interview aims to highlight Unicycive's innovative approaches in treating significant kidney diseases with unmet medical needs.
Unicycive Therapeutics (Nasdaq: UNCY) announced participation in two key conferences to highlight their innovative therapies. The Sequire Technology Conference will feature a company presentation on November 30, 2022, at 11:30 a.m. ET. Additionally, Unicycive will engage in 1x1 meetings at Benchmark’s 11th Annual Discovery Conference on December 1, 2022, at the New York Athletic Club. The company is developing Renazorb for hyperphosphatemia and UNI-494 for mitochondrial dysfunction, targeting unmet medical needs in kidney diseases.
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