Unicycive Therapeutics develops investigational treatments for kidney diseases, with news centered on its clinical-stage pipeline, regulatory communications, financial results, and investor presentations. Its lead program, oxylanthanum carbonate, is an oral phosphate binder being developed for hyperphosphatemia in chronic kidney disease patients on dialysis, and company updates frequently address NDA activity, chemistry, manufacturing and controls matters, and commercial-readiness planning.
Unicycive also reports developments for UNI-494, a drug candidate for conditions related to acute kidney injury, including its FDA orphan drug designation for prevention of delayed graft function in kidney transplant patients and completed Phase 1 safety work. Recurring announcements include business updates, conference participation, and capital or cash-position disclosures tied to advancing the kidney-disease portfolio.
Unicycive Therapeutics (Nasdaq: UNCY) announced the publication of pivotal trial data for oxylanthanum carbonate (OLC) in the Clinical Journal of the American Society of Nephrology. The Phase 2 clinical trial demonstrated that OLC effectively controlled serum phosphate levels in over 90% of chronic kidney disease (CKD) patients on dialysis with hyperphosphatemia.
The study, involving 86 patients, showed that two-thirds of participants achieved target phosphate levels with three or fewer tablets daily. The treatment demonstrated minimal to no systemic absorption and was well-tolerated, with only 4% of patients discontinuing due to treatment-related adverse events. The most common side effects were gastrointestinal, including diarrhea (9%) and vomiting (6%).
Unicycive Therapeutics (NASDAQ:UNCY), a clinical-stage biotechnology company focused on kidney disease therapies, has successfully regained compliance with Nasdaq's minimum bid price requirement. The compliance was achieved following a 1:10 reverse stock split that became effective on June 20, 2025.
The company received official confirmation from Nasdaq's Listing Qualifications Department on July 7, 2025, stating that UNCY's common stock has maintained an average closing share price of at least $1.00. This resolves the previous listing compliance issue, and Nasdaq has officially closed the matter.
Unicycive Therapeutics (Nasdaq: UNCY), a clinical-stage biotech company focused on kidney disease treatments, has announced its participation in the upcoming H.C. Wainwright 4th Annual Kidney Virtual Conference. The company's CEO, Dr. Shalabh Gupta, will engage in a fireside chat on July 14, 2025, at 11:00 AM ET.
Investors and interested parties can access the webcast through the Events and Presentations section of Unicycive's website under the Investors tab.
Unicycive Therapeutics (Nasdaq: UNCY) announced receiving a Complete Response Letter (CRL) from the FDA regarding its New Drug Application (NDA) for Oxylanthanum Carbonate (OLC), intended to treat hyperphosphatemia in chronic kidney disease patients on dialysis.
The CRL cited deficiencies at a third-party manufacturing vendor unrelated to OLC itself. The FDA did not raise concerns about pre-clinical, clinical, or safety data. The company has identified a second manufacturing vendor that has already produced OLC drug product and could help resolve the Clinical Manufacturing and Controls (CMC) issues.
Unicycive plans to request a Type A meeting with the FDA to discuss next steps. The company reports an unaudited cash balance of approximately $20.7 million, with runway expected into the second half of 2026.
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.