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Unicycive Therapeutics (UNCY) has resubmitted an NDA to the US FDA for its candidate for hyperphosphatemia in individuals with chronic kidney disease, oxylanthanum carbonate. In late June, the company...
2025-12-30 05:25
The NDA for OLC was resubmitted based on continued progress by the original third-party manufacturing vendor in resolving FDA-cited deficiencies and demonstrating inspection readiness. Unicycive previously discussed
2025-12-29 20:08
Unicycive Therapeutics has resubmitted its NDA for oxylanthanum carbonate (OLC) to the FDA for treating hyperphosphatemia in CKD dialysis patients. The resubmission follows progress by the third-party manufacturer to regain FDA compliance. With adequate funding, the company aims to complete the regulatory process and bring the treatment to market soon. The NDA resubmission aligns with a Type A meeting with the FDA in September 2025, addressing pr...
2025-12-29 12:05
Unicycive Therapeutics, Inc., a biotechnology company focused on developing treatments for kidney diseases, announced that its CEO, Shalabh Gupta, M.D., will participate in two investor events in December. The events include a fireside chat at the Piper Sandler 37th Annual Healthcare Conference on December 3, 2025, and a virtual presentation by Noble Capital Markets on December 10, 2025. Links to the webcasts will be available on the company's we...
2025-11-25 12:05
Unicycive Therapeutics ( ($UNCY) ) just unveiled an announcement. On November 1...
2025-11-15 06:34
Unicycive Therapeutics announced its Q3 2025 financial results and business updates, highlighting its plan to resubmit the New Drug Application (NDA) for oxylanthanum carbonate (OLC) by year-end. OLC showed significant reduction in pill burden for hyperphosphatemia patients, with 7x lower volume and 2x fewer pills compared to existing treatments. The company ended Q3 with $42.7 million in cash, expecting runway into 2027. R&D expenses decreased s...
2025-11-12 12:05
今日重点评级关注:HC Wainwright & Co.:维持Unicycive Therapeutics"买入"评级,目标价从9美元升至22美元;花旗:维持Arcus Biosciences"买入"评级,目标价从54美元升至56美元
2025-10-30 14:22
Unicycive Therapeutics, Inc. (NASDAQ:UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease (the Company or Unicycive), today announced an update from its meeting with the
2025-10-28 19:10
<p>Unicycive Therapeutics announced plans to resubmit its New Drug Application (NDA) for Oxylanthanum Carbonate (OLC) by year-end following a constructive FDA meeting. The company aims for a PDUFA date in early 2026. With $42 million in cash, it expects to maintain operations into 2027. OLC, an investigational phosphate binder, offers potential advantages in reducing pill burden for dialysis patients with hyperphosphatemia. The company remains fo...
2025-10-28 11:05
Aclass actionlawsuit was filed againstUnicycive Therapeutics ...
2025-09-30 21:18