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 (NASDAQ:UNCY), a clinical-stage biotech company focused on kidney disease treatments, has released its Q2 2025 financial results and business updates. The company has requested a Type A meeting with the FDA to address the Complete Response Letter (CRL) for oxylanthanum carbonate (OLC), with the meeting expected within 30 days.
Recent pivotal trial data published in CJASN demonstrated that OLC achieved effective phosphate control in over 90% of dialysis patients with a low pill burden. Financial highlights include $22.3 million in cash, providing runway into H2 2026, R&D expenses of $1.8 million (down from $4.9 million), and G&A expenses of $5.2 million (up from $2.5 million). The company reported a net loss of $6.4 million for Q2 2025.
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%).
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