Unicycive Therapeutics Appoints New Director; Resubmits NDA for Oxylanthanum Carbonate
Unicycive Therapeutics, Inc. announced the appointment of Meredith S. Manning as an independent director to its board, effective October 1, 2026. Ms. Manning will also chair the Nominating and Corporate Governance Committee and serve on the Audit and Compensation Committees. In a separate announcement, the company resubmitted its New Drug Application (NDA) for oxylanthanum carbonate, an oral phosphate binder for hyperphosphatemia in chronic kidney disease patients. The resubmission includes updated CMC data from a new manufacturing vendor, and the company anticipates FDA acceptance within 30 days with a PDUFA date six months thereafter. The company's current cash position provides runway into the second half of 2027.
Key Highlights
- Unicycive Therapeutics appoints Meredith S. Manning as an independent director to its board, effective October 1, 2026.
- Meredith S. Manning will serve on the Audit, Compensation, and Nominating and Corporate Governance Committees.
- Manning will also serve as the Chairperson of the Nominating and Corporate Governance Committee.
- Manning brings over 25 years of global biopharmaceutical experience, including leadership roles at Soleno Therapeutics and PharmaEssentia.
- Unicycive Therapeutics resubmitted its New Drug Application (NDA) for Oxylanthanum Carbonate.
- The NDA resubmission includes CMC data from a new third-party drug product manufacturing vendor.
- Company anticipates FDA acceptance of the NDA within 30 days; new PDUFA date expected 6 months from resubmission.
- Unicycive Therapeutics has a cash position supporting runway into the second half of 2027.
Price Impact
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