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 (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.
Unicycive Therapeutics (Nasdaq: UNCY) announced a late-breaker poster presentation on oxylanthanum carbonate (OLC) at the American Society of Nephrology (ASN) Kidney Week 2024. The presentation, titled 'Effects of Oxylanthanum Carbonate in Patients Receiving Maintenance Hemodialysis with Hyperphosphatemia,' will be led by Dr. Geoffrey A. Block. Additionally, Unicycive will deliver three more poster presentations on OLC and UNI-494.
The conference will take place from October 24-27, 2024, in San Diego, CA. The additional presentations will cover topics such as the effects of intravenous UNI-494 on acute kidney injury, the combination of OLC and tenapanor in lowering urinary phosphate excretion, and the Phase I safety, tolerability, and pharmacokinetics of UNI-494. These presentations highlight Unicycive's ongoing research in kidney disease treatments.
Unicycive Therapeutics (Nasdaq: UNCY) has successfully completed the Phase 1 study of UNI-494 in healthy volunteers. The study, conducted in the UK, assessed safety, tolerability, and pharmacokinetics of UNI-494. Key findings include:
1. Single Ascending Dose: Well-tolerated from 10 mg to 160 mg with no serious adverse events.
2. Multiple Ascending Dose: Safe and well-tolerated at 40 mg twice daily for 5 days.
3. Pharmacokinetics: Rapid absorption and metabolism of UNI-494, releasing nicorandil.
The company plans to request an FDA meeting to review results and discuss potential Phase 2 study design for acute kidney injury patients. CEO Shalabh Gupta called this an important milestone for UNI-494's clinical development.
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