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 (Nasdaq: UNCY) reported its financial results for Q1 2022, revealing a net loss of $3.5 million ($0.24 per share), up from $1.0 million ($0.11 per share) in Q1 2021. Research and development expenses rose to $1.9 million, mainly due to ongoing drug development for Renazorb and UNI-494. The company is set to begin a bioequivalence study for Renazorb in Q2 2022 and anticipates filing a 505(b)(2) NDA. With $13.6 million in cash, Unicycive is adequately funded for upcoming milestones, including the clinical trial for UNI-494 planned for later in 2022.
Unicycive Therapeutics (Nasdaq: UNCY) announced a Key Opinion Leader (KOL) Event featuring Dr. Glenn Chertow from Stanford University on April 20, 2022. The event, titled “Novel Treatments in Kidney Disease,” aims to discuss innovative therapies for kidney disease, particularly hyperphosphatemia affecting over 500,000 chronic kidney disease patients in the U.S. Unicycive is developing Renazorb, a phosphate binder, and a pro-drug of nicorandil for treating both acute and chronic kidney conditions. The live webcast will be available for 90 days post-event.
Unicycive Therapeutics (Nasdaq: UNCY) reported its financial results for 2021, highlighting significant progress in clinical development. The FDA confirmed a regulatory pathway for its lead product, Renazorb, aimed at treating hyperphosphatemia in chronic kidney disease patients. The company plans to initiate a clinical bioequivalence study in healthy volunteers in Q2 2022. R&D expenses rose to $6.1 million from $1.0 million in 2020, while the net loss increased to $10.0 million, or $0.86 per share. Cash and equivalents stood at $16.6 million as of December 31, 2021.
Unicycive Therapeutics will celebrate National Kidney Month by ringing the Nasdaq Closing Bell on March 29, 2022, at 4:00 PM ET. The event, featuring CEO Shalabh Gupta, highlights the unmet medical needs for kidney disease treatments. Unicycive is progressing towards regulatory approval for its lead drug, Renazorb, aimed at treating hyperphosphatemia, and plans to file for UNI-494 targeting acute kidney injury later in the year. The Nasdaq listing has enhanced liquidity and visibility among institutional investors.
Unicycive Therapeutics (Nasdaq: UNCY) has announced that Dr. Shalabh Gupta, CEO, will present at two investor conferences in March 2022. The first is the 34th Annual ROTH Conference from March 13-15, where Dr. Gupta will offer an online presentation and participate in one-on-one meetings. The second event is the Maxim Group 2nd Annual Virtual Growth Conference on March 28 at 1:00 pm Eastern Time, featuring a fireside chat format. Unicycive is focused on developing innovative therapies for kidney diseases, including its lead drug Renazorb.
Unicycive Therapeutics (Nasdaq: UNCY) announced that two abstracts highlighting the efficacy and safety of Renazorb (lanthanum dioxycarbonate) will be presented at the National Kidney Foundation (NKF) Spring Clinical Meeting from April 6-10, 2022, in Boston. Renazorb aims to treat hyperphosphatemia in chronic kidney disease patients, utilizing advanced nanoparticle technology for better phosphate binding. The data presented will support Renazorb's potential as a leading phosphate binder with fewer dosage pills required.
Unicycive Therapeutics, a clinical stage biotechnology company focused on kidney disease therapies, announced that CEO Shalabh Gupta will present at the H.C. Wainwright BIOCONNECT Virtual Conference from January 10-13, 2022. The presentation can be accessed on the company's website under the Investors section starting January 10, 2022, at 7:00 a.m. ET. Unicycive is developing innovative treatments, including Renazorb, a phosphate binding agent for hyperphosphatemia, and UNI-494, a new chemical entity in late preclinical development for acute kidney injury.
Unicycive Therapeutics (Nasdaq: UNCY) announced progress on Renazorb, a second-generation phosphate binding agent for hyperphosphatemia in chronic kidney disease patients. Following a Type C interaction, the FDA confirmed the drug's comparability to Fosrenol and endorsed the 505(b)(2) NDA submission pathway based on a clinical bioequivalence study. The upcoming study will include a comparator arm with Fosrenol. Unicycive plans to file the NDA in Q4 2022, indicating readiness to proceed with the remaining study.
Unicycive Therapeutics (Nasdaq: UNCY) reported its Q3 2021 financial results, showing a net loss of $5.2 million, or $0.37 per share, a dramatic rise from a $0.7 million loss in Q3 2020. Key developments include the addition to the Russell Microcap Index and the hiring of Douglas Jermasek as Executive VP of Corporate Strategy. The company anticipates confirmatory guidance from the FDA regarding its lead drug, Renazorb, aimed at treating hyperphosphatemia in chronic kidney disease, in Q4 2021.
Unicycive Therapeutics, a clinical-stage biotechnology firm focused on kidney disease therapies, has appointed Douglas Jermasek as Executive Vice President, Corporate Strategy. Jermasek brings over 25 years of industry experience, including significant roles at Akebia and Genzyme, where he drove over $1 billion in sales. His expertise in kidney disease therapy is expected to enhance Unicycive’s corporate and commercial strategies. This appointment signals the company’s commitment to addressing challenges in kidney care and advancing its lead drug, Renazorb, aimed at treating hyperphosphatemia.
