Unicycive Therapeutics, Inc. (UNCY) has recently received an orphan drug designation from the FDA for UNI-494, a drug intended to prevent Delayed Graft Function in kidney transplant patients. On March 12, 2024, the company will be presenting data related to the efficacy of UNI-494 from animal models of Delayed Graft Function. They will also unveil a poster that details the ongoing Phase 1 clinical trial design for UNI-494 among healthy volunteers. This event will take place at the 29th International Conference on Advances in Critical Care Nephrology AKI and CRRT 2024.
CEO of Unicycive, Shalabh Gupta, considers the orphan drug designation an important achievement in the development of UNI-494. This designation could potentially bring about certain tax credits for qualified clinical trials, an exemption of user fees, and the possibility of seven years of market exclusivity post-approval.
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