Unicycive Therapeutics (NASDAQ: UNCY) stock is down 35% today after the U.S. Food and Drug Administration (FDA) flagged significant compliance deficiencies at a third-party manufacturing vendor involved in producing its investigational kidney therapy, oxylanthanum carbonate (OLC).
During an inspection, the FDA identified current Good Manufacturing Practice (cGMP) issues at a subcontractor of Unicycive’s contract development and manufacturing organization—not at the drug substance vendor itself. As a result, the FDA has halted any label discussions with Unicycive, casting uncertainty over the drug’s approval timeline.
The company has responded to all FDA information requests and still expects a final decision on its New Drug Application (NDA) by the Prescription Drug User Fee Act (PDUFA) action date of June 28, 2025.
Despite management’s confidence in the drug’s clinical promise and ongoing efforts to resolve the regulatory concerns, the setback has triggered sharp selling pressure, as investors worry about potential approval delays and the impact on Unicycive’s future revenue prospects.
While Wall Street analysts maintain an “Outperform” rating and see substantial long-term upside if the issues are resolved, today’s steep decline reflects immediate investor anxiety over regulatory risk and uncertainty surrounding the path to market for OLC.
