Unicycive Therapeutics Faces Class Action Over Manufacturing Oversight

The litigation targets the period between December 29, 2025, and June 29, 2026, centering on the company’s reliance on third-party vendors. According to the complaint, Unicycive proceeded with a New Drug Application resubmission despite a June 2025 FDA warning regarding current Good Manufacturing Practice deficiencies at its manufacturer’s facility. Plaintiffs argue the company lacked a reasonable basis to believe these issues had been resolved, having never conducted its own audit or inspection of the site.

The consequences of this reliance became apparent on June 30, 2026, when Unicycive announced a second Complete Response Letter from the FDA. The regulator cited the identical manufacturing deficiencies that had stalled the previous application. Following the announcement, UNCY shares plummeted from a class-period high of $8.56 to close at $4.69. Joseph E. Levi, representing the plaintiffs, stated that the company owed shareholders an accurate account of its verification process rather than relying on unconfirmed assumptions of vendor progress. Investors seeking to serve as lead plaintiff must file motions with the court by November 2, 2026.