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 whose news flow centers on the development and regulatory progress of kidney disease therapies. Company press releases highlight advances for its lead investigational product oxylanthanum carbonate (OLC), an oral phosphate binder for hyperphosphatemia in chronic kidney disease patients on dialysis, and for its second program UNI-494, which is intended for conditions related to acute kidney injury.
Investors following UNCY news can expect detailed updates on regulatory interactions with the U.S. Food and Drug Administration, including New Drug Application submissions, Complete Response Letters, Type A meetings, and NDA resubmissions for OLC. The company also reports on pivotal and Phase 2 clinical trial results, analyses of pill burden and phosphate control, and publications of OLC data in peer-reviewed journals such as the Clinical Journal of the American Society of Nephrology.
Unicycive’s news releases frequently cover financial results, cash runway commentary, and capital markets activities, such as at-the-market equity offerings and reverse stock split implementation, as disclosed in associated Form 8-K filings. Additional news items include participation in healthcare and investor conferences, issuance of new patents for UNI-494 and its use in chronic kidney disease, and corporate updates on Nasdaq listing compliance and legal matters, including disclosure of a purported securities class action.
This UNCY news page aggregates these company-issued updates so readers can review clinical data milestones, regulatory developments, intellectual property announcements, and financial disclosures in one place. For those tracking the progress of oxylanthanum carbonate and UNI-494, the news feed provides a chronological view of Unicycive’s communications about its kidney disease pipeline and corporate activities.
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.
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.
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