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 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.
Unicycive Therapeutics (Nasdaq: UNCY) announced third-quarter 2022 financial results and significant business updates. The company has completed enrollment for its pivotal bioequivalence study of RENAZORB, an investigational phosphate binder for hyperphosphatemia in CKD patients, with topline results expected by year-end. They plan to file a New Drug Application (NDA) in 2023. Unicycive has also signed a global partnership for RENAZORB’s commercialization in China, receiving $1 million upfront. Research and development expenses increased to $4.8 million, resulting in a net loss of $5.6 million for the quarter.
Unicycive Therapeutics, Inc. (Nasdaq: UNCY) has completed subject enrollment in the RENAZORB bioequivalence study, aimed at treating hyperphosphatemia in chronic kidney disease patients on dialysis. The randomized BE study, approved by the FDA, involves 80 subjects and measures urinary phosphate excretion changes. Topline data is expected by year-end 2022, with plans to file a New Drug Application (NDA) in 2023. RENAZORB's unique nanoparticle technology may enhance patient adherence compared to existing treatments. The company anticipates significant market opportunities for this advanced phosphate binder.
Unicycive Therapeutics (Nasdaq: UNCY) is set to showcase its kidney disease therapies at the ASN Kidney Week 2022, scheduled for Nov 3-6, in Orlando, Florida. CEO Shalabh Gupta highlighted the serious issue of hyperphosphatemia in end-stage renal patients and discussed the potential of Renazorb, an advanced phosphate binder, and UNI-494, a candidate for acute kidney injury treatment. Clinical trials for Renazorb have demonstrated its safety and efficacy, significantly reducing phosphate excretion. The company aims to transform treatment for kidney disorders, addressing major compliance challenges.
Unicycive Therapeutics (Nasdaq: UNCY) will present at the Roth Inaugural Healthcare Opportunities Conference on October 6, 2022, in New York City. CEO Shalabh Gupta will share insights into the company's late-stage program targeting hyperphosphatemia and an early-stage program addressing mitochondrial dysfunction diseases. Investors can schedule one-on-one meetings through Roth representatives. The firm is advancing its lead drug, Renazorb, a phosphate-binding agent, and UNI-494, a new chemical entity for acute kidney injury treatment. For inquiries, investors can contact ir@unicycive.com.
Unicycive Therapeutics (Nasdaq: UNCY) announced promising preclinical results for its drug UNI-494, targeted at treating Acute Kidney Injury (AKI). In a study involving a rodent model of AKI, UNI-494 significantly reduced levels of β-2 microglobulin, a key biomarker for kidney damage. The company aims to file for regulatory approval by the end of 2022 to start a Phase 1 human study. UNI-494 works by activating mitochondrial KATP channels, potentially offering therapeutic benefits beyond AKI, including chronic kidney and liver diseases.
Unicycive Therapeutics, a clinical stage biotechnology company focused on therapies for kidney disease, announced its participation in the H.C. Wainwright 24th Annual Global Investment Conference from September 12-14, 2022. CEO Shalabh Gupta will provide a corporate overview via a virtual presentation available on demand starting at 7:00 am ET on September 12. The presentation will be accessible for 90 days on their website. Unicycive is developing innovative treatments for hyperphosphatemia and acute kidney injury.
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