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 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) reported outcomes from an FDA Type A meeting and said it plans to resubmit the NDA for Oxylanthanum Carbonate (OLC) by year-end 2025 after receiving a Complete Response Letter (CRL) on June 30, 2025.
The CRL cited a single deficiency tied to the compliance status of a third-party manufacturing vendor; no preclinical, clinical, or safety concerns were identified. The company said FDA meeting minutes were constructive and it is engaging the vendor to resolve the issue, potentially yielding a PDUFA date in H1 2026.
Unicycive reported $42 million cash as of September 30, 2025, which it says provides a cash runway into 2027 to support the resubmission, potential approval, and commercialization preparations for OLC.
Unicycive Therapeutics (Nasdaq: UNCY), a clinical-stage biotech company focused on kidney disease treatments, has announced its participation in two upcoming investor events in September 2025.
CEO Shalabh Gupta will participate in a fireside chat at the H.C. Wainwright 27th Annual Global Investment Conference on September 10 at 8:30 a.m. ET, followed by another fireside chat at the Truist Securities Virtual event on September 17 at 10 a.m. ET. Webcasts will be available on the company's investor relations website.
Unicycive Therapeutics (Nasdaq: UNCY) has secured a new U.S. Patent (12,377,082) for UNI-494, extending intellectual property protection until 2040 for treating Chronic Kidney Disease (CKD). This patent complements an existing patent for UNI-494's use in treating Acute Kidney Injury.
The company has already completed a Phase I clinical study of UNI-494 in healthy volunteers and received Orphan Drug Designation for preventing delayed graft function in kidney transplant patients. While Unicycive's primary focus remains on FDA approval for oxylanthanum carbonate, this patent strengthens their intellectual property portfolio and enhances partnership opportunities.
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.