Investors Target Unicycive Therapeutics Over Failed FDA Compliance

The complaint filed by Robbins LLP alleges that Unicycive lacked a reasonable basis for its positive business outlook while seeking approval for its kidney disease therapy, oxylanthanum carbonate. Despite a Type A meeting with the FDA in October 2025 intended to resolve outstanding manufacturing issues, the company reportedly failed to inspect the vendor’s facility or confirm the status of necessary corrective actions.

This oversight came to light on June 30, 2026, when Unicycive announced that the FDA had issued a second Complete Response Letter citing the same manufacturing deficiencies identified a year prior. Shares of UNCY plummeted by $3.01 that day, closing at $4.69. Investors who suffered significant losses during the class period must contact the firm by November 2, 2026, to be considered for the lead plaintiff role, a position that carries no upfront costs for participants.