Unicycive Therapeutics Inc Stock Price, News & Analysis

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.

Unicycive Therapeutics (NASDAQ: UNCY), a clinical-stage biotech company focused on kidney disease therapies, has announced a 1-for-10 reverse stock split effective June 18, 2025. The stock will begin trading on a split-adjusted basis on June 20, 2025, maintaining its NASDAQ symbol "UNCY". This corporate action aims to regain compliance with NASDAQ's $1.00 minimum bid price requirement. The split will reduce outstanding shares from approximately 126.4 million to 12.6 million. Stockholders approved this action on June 9, 2025. The split will automatically round up fractional shares and proportionally adjust exercise prices of stock options, warrants, and conversion prices of preferred stock. No stockholder action is required for those holding shares through brokers.

Unicycive Therapeutics (NASDAQ: UNCY) announced that the FDA has identified compliance deficiencies at a third-party manufacturing vendor during the review of their New Drug Application (NDA) for oxylanthanum carbonate (OLC). The drug is intended to treat hyperphosphatemia in chronic kidney disease patients on dialysis. The FDA has indicated that these deficiencies, found at a CDMO's third-party subcontractor, prevent further label discussions. While Unicycive has responded to all FDA information requests, the final decision is expected by the PDUFA date of June 28, 2025. CEO Shalabh Gupta expressed confidence in OLC's potential based on their clinical and preclinical data, despite the manufacturing setback.

Unicycive Therapeutics (NASDAQ: UNCY), a clinical stage biotech company focused on kidney disease therapies, has announced a time change for its 2025 Annual Meeting of Stockholders. The meeting will now be held at 7:00 a.m. PDT on June 9, 2025, at 4300 El Camino Real, Suite 210, Los Altos, CA 94022. The date and location remain unchanged from the previous announcement. Stockholders of record as of April 30, 2025 can access additional meeting participation details at the company's annual general meetings website.