Unicycive Therapeutics Inc Stock Price, News & Analysis

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.

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.