Unicycive Therapeutics Inc Stock Price, News & Analysis

Unicycive Therapeutics reported its Q1 2025 financial results and provided key business updates. The company's lead product, oxylanthanum carbonate (OLC) for treating hyperphosphatemia in chronic kidney disease patients on dialysis, has a PDUFA target date of June 28, 2025. Recent patient surveys highlighted adherence challenges with current treatments and demonstrated strong preference for OLC's reduced pill burden. Financial highlights include: R&D expenses decreased to $2.2M from $6.8M YoY, while G&A expenses increased to $5.8M from $2.4M due to commercial launch preparations. The company reported a net income of $0.5M compared to a $21.2M loss in Q1 2024, primarily due to warrant liability changes. Cash position stood at $19.8M as of March 31, 2025.

Unicycive Therapeutics (NASDAQ: UNCY) presented new patient-level data for its investigational hyperphosphatemia treatment, oxylanthanum carbonate (OLC), at the NKF Spring Clinical Meetings in Boston. The FDA has set a PDUFA date of June 28, 2025, for OLC's New Drug Application.

Key findings from the Phase 2 trial showed that OLC reduced pill burden by 50%, with patients taking a median of three tablets daily compared to six with previous treatments. Patient satisfaction metrics were notably strong: 70% reported consistent adherence with OLC (vs 58% for prior treatments), 79% preferred OLC over previous medications, and 98% found it easy to take (vs 38% for prior treatments).

A separate NKF survey of 200 dialysis patients identified key barriers to phosphate binder adherence: forgetfulness (63%), excessive pill number (47%), and large pill size (47%). Other challenges included difficulties carrying pills (45%), gastrointestinal side effects (29%), and unpleasant taste (20%).

Unicycive Therapeutics (Nasdaq: UNCY), a clinical-stage biotechnology company focused on kidney disease therapies, has announced its participation in the 24th Annual Needham Virtual Healthcare Conference.

The company's CEO, Shalabh Gupta, M.D., is scheduled to present on Monday, April 7, at 2:15 p.m. ET. Investors and interested parties can access both the live and archived webcast through the Events and Presentations section of the Unicycive website's Investor portal. One-on-one meetings with management can be arranged through Needham representatives.

Unicycive Therapeutics (NASDAQ: UNCY) reported its full year 2024 financial results and business updates. The company's lead product, oxylanthanum carbonate (OLC) for hyperphosphatemia treatment in chronic kidney disease patients on dialysis, has a FDA PDUFA target date of June 28, 2025.

Financial highlights include: Net loss increased to $37.8 million ($0.56 per share) compared to $31.4 million in 2023. R&D expenses rose to $20.0 million from $12.9 million, while G&A expenses increased to $12.1 million from $8.5 million. Cash position stands at $26.1 million, sufficient to fund operations into 2026.

The company's Korean partner, Lotus Pharmaceutical, submitted an NDA for OLC with potential milestone payments up to $3.7 million plus tiered royalties. Unicycive completed a Phase 1 study of UNI-494 showing favorable tolerability.

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.