Unicycive Stock Plunges 39% as FDA Rejects Kidney Drug Again
San Diego – September 11, 2026 -- Shareholder rights firm Robbins LLP has filed a class action against Unicycive Therapeutics, Inc. (NASDAQ: UNCY) on behalf of investors who purchased the biotech's securities between December 29, 2025 and June 29, 2026, after the FDA rejected the company's kidney disease drug for a second time over unresolved manufacturing deficiencies.
FDA Issues Second Rejection Citing Identical Manufacturing Flaws
On June 30, 2026, before markets opened, Unicycive disclosed that the FDA had issued a Complete Response Letter for its resubmitted New Drug Application for oxylanthanum carbonate (OLC), identifying the "same third-party manufacturing deficiencies that were identified in the previous CRL issued in June 2025." Shares fell $3.01, or 39.1%, to close at $4.69 on unusually heavy trading volume that day.