Unicycive Therapeutics: FDA Grants Orphan Drug Designation To UNI-494

(RTTNews) - Unicycive Therapeutics, Inc. (UNCY) announced the FDA has granted orphan drug designation to UNI-494 for the prevention of Delayed Graft Function in kidney transplant patients. On March 12, 2024, the company will present data on the efficacy of UNI-494 in animal models of Delayed Graft Function and a poster describing the ongoing Phase 1 clinical trial design for UNI-494 in healthy volunteers at the 29th International Conference on Advances in Critical Care Nephrology AKI and CRRT 2024.

Shalabh Gupta, CEO of Unicycive, said: "Obtaining orphan drug designation is an important milestone in the development of UNI-494 that may provide certain tax credits for qualified clinical trials, exemption of user fees, and the potential for seven years of market exclusivity after approval."

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