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 (UNCY) announced the presentation of patient reported outcomes data from its pivotal UNI-OLC-201 clinical study of oxylanthanum carbonate (OLC) for treating hyperphosphatemia in chronic kidney disease patients on dialysis. The data will be presented at three major medical meetings in 2025: the Annual Dialysis Conference (March 13-16), National Kidney Foundation Spring Clinical Meetings (April 10-13), and American Nephrology Nurses Association National Symposium (May 1-4).
The company's OLC, utilizing proprietary nanoparticle technology, aims to reduce pill size and quantity for patients. The FDA has accepted OLC's New Drug Application with a PDUFA Target Action Date of June 28, 2025. Currently, hyperphosphatemia remains uncontrolled in 75% of U.S. dialysis patients due to issues with existing treatments.
The presentations will highlight how OLC reduces pill burden by half and improves treatment adherence, potentially offering a more effective solution for phosphate control in dialysis patients.
Unicycive Therapeutics (UNCY) has published preclinical data in the ASN journal Kidney360 demonstrating synergistic benefits of combining oxylanthanum carbonate (OLC) with tenapanor for phosphate management. The study showed that the combination therapy achieved a 41.3% reduction in urinary phosphate excretion compared to vehicle, significantly outperforming both individual treatments.
Key results showed tenapanor alone achieved a 12.5% reduction, while OLC monotherapy demonstrated a 17.7% reduction in phosphate excretion. The combination proved statistically significant (p=0.009 for 0.75% OLC + tenapanor). This research is particularly relevant as approximately 75% of dialysis patients fail to meet serum phosphate targets set by KDIGO guidelines. The study suggests OLC's low pill burden and palatable formulation, combined with tenapanor, could improve patient adherence and clinical outcomes in hyperphosphatemia treatment.
Unicycive Therapeutics (UNCY) announced the publication of a review on patient perspectives regarding phosphate management in the Journal of Nephrological Science. The study highlights significant challenges in phosphate management therapies, particularly focusing on phosphate binders used by chronic kidney disease (CKD) patients.
The research revealed that non-adherence rates to phosphate binders range from 22% to 74%, with a mean rate of 51%. Key barriers identified include large pill size, high pill burden (making up about 50% of daily pills), and palatability issues. The company positions its product, Oxylanthanum Carbonate (OLC), as a potential solution, highlighting its smaller pill size and lower pill burden.
The publication emphasizes the importance of understanding patient challenges in phosphorus management, as hyperphosphatemia is linked to increased mortality risk in dialysis patients. The findings suggest that new therapies reducing pill size and burden while maintaining efficacy could improve clinical outcomes and patient satisfaction.
Unicycive Therapeutics (UNCY) has published positive Phase 1 dose escalation study results for oxylanthanum carbonate (OLC) in Clinical and Translational Science journal. The study evaluated OLC's safety at different doses (500mg, 1000mg, 1500mg, or 2000mg three times daily) in 32 healthy volunteers.
Key findings show that OLC was well-tolerated with no serious adverse events, and demonstrated dose-dependent decreases in urinary phosphorus excretion from baseline, indicating effective phosphate binding. Most treatment-emergent adverse events were mild in severity.
The data is a important component of OLC's New Drug Application currently under FDA review, with a PDUFA date of June 28, 2025.
Unicycive Therapeutics (UNCY) announced the publication of positive bioequivalence data for oxylanthanum carbonate (OLC) in Clinical Therapeutics journal. The study demonstrated pharmacodynamic bioequivalence between OLC and Fosrenol® (lanthanum carbonate) in treating hyperphosphatemia in kidney disease patients.
The randomized crossover study involved 80 participants, with 75 completing all doses. Results showed similar least squares mean change in urinary phosphate excretion: OLC (-320.4 mg/day) versus LC (-324.0 mg/day), with a between-group difference of 3.6 mg/day. Both treatments were well-tolerated with comparable adverse event profiles. The company's New Drug Application for OLC is under review, with commercial launch planned for 2025.
Unicycive Therapeutics (Nasdaq: UNCY), a clinical-stage biotech focusing on kidney disease therapies, announced its participation in two upcoming investor conferences. CEO Shalabh Gupta will deliver a corporate presentation at the Noble Capital Markets 20th Annual Emerging Growth Equity Conference on December 3, 2024, at 3:00 p.m. ET in Boca Raton, FL. Additionally, he will participate in a fireside chat at the Piper Sandler 36th Annual Healthcare Conference on December 5, 2024, at 12:30 p.m. ET in New York. Live and archived webcasts will be available on Unicycive's website under the Investors section.
Unicycive Therapeutics (UNCY) reported Q3 2024 financial results and business updates. Key highlights include FDA acceptance of the New Drug Application for oxylanthanum carbonate (OLC) with a PDUFA date of June 28, 2025, and successful completion of UNI-494 Phase 1 trial. Q3 financial results showed R&D expenses of $3.0M (down from $3.4M in Q3 2023), G&A expenses of $3.2M (up from $2.6M), and a net loss of $4.1M (improved from $4.4M). Cash position stands at $32.3M, sufficient to fund operations into 2026.
Unicycive Therapeutics announced FDA acceptance of its New Drug Application (NDA) for Oxylanthanum Carbonate (OLC) for treating hyperphosphatemia in chronic kidney disease patients on dialysis. The FDA set a PDUFA target date of June 28, 2025. OLC aims to reduce treatment burden by requiring fewer and smaller pills that can be swallowed rather than chewed. The NDA submission includes data from three clinical studies and is seeking approval via the 505(b)(2) pathway. The company received an FDA fee waiver, saving approximately $4 million, and is preparing for commercial launch in second half of 2025 if approved.
Unicycive Therapeutics (UNCY) presented multiple studies at ASN Kidney Week 2024, highlighting progress on oxylanthanum carbonate (OLC) and UNI-494. The late-breaking presentation showed OLC enabled serum phosphate control in >90% of chronic kidney disease patients on dialysis who entered maintenance phase, with 69% achieving target levels at ≤1500 mg/day. The company also presented positive Phase 1 safety data for UNI-494. Two recent publications featured preclinical studies for both compounds. OLC demonstrated synergistic effects when combined with tenapanor in rat studies, while UNI-494 showed potential in treating acute kidney injury.
Unicycive Therapeutics (Nasdaq: UNCY), a clinical-stage biotechnology company focused on kidney disease therapies, has announced its participation in the 2024 Maxim Healthcare Virtual Summit. The company's CEO, Shalabh Gupta, M.D., will engage in a fireside chat on October 17, 2024, at 10:00 a.m. ET.
Interested parties can access the live and archived webcast through the Unicycive website under the Investors section, specifically in the Events and Presentations area. The webcast archive will remain available for three months following the event.
This participation provides an opportunity for investors and stakeholders to gain insights into Unicycive's developments and strategies in the field of kidney disease treatments.
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