UNCY - Unicycive stock rises on UK drug regulator nod for UNI-494 to enter phase 1 trial

• Unicycive Therapeutics ( NASDAQ: UNCY ) said U.K.'s Medicines and Healthcare Products Regulatory Agency (MHRA) cleared its application seeking to start a phase 1 trial of UNI-494 in healthy volunteers.
• The MHRA accepted completed review of the clinical trial application (CTA) and issued a notice of acceptance for UNI-494.
• The company noted that UNI-494 is a patent-protected new chemical entity in late preclinical development to treat acute kidney injury.
• "We've selected a qualified UK-based Contract Research Organization (CRO) to conduct the Phase 1 study, which we expect will begin dosing patients in the first quarter of 2023. We also plan to file a corresponding Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) in 2023 for a Phase 2 proof-of-concept trial in acute kidney injury (AKI) patients with a background of CKD (Chronic Kidney Disease)," said Unicycive CEO Shalabh Gupta.
• UNCY +4.07% to $0.73 premarket Dec. 22

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