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.
Complaint Alleges Company Never Inspected Vendor Facility
The lawsuit claims Unicycive failed to inspect or audit its third-party manufacturing vendor's compliance with current good manufacturing practices before assuring investors the FDA's concerns had been addressed. According to the complaint, the company lacked a reasonable basis to believe the vendor had resolved the deficiencies first cited by regulators in June 2025.
Regulatory Timeline Shows Repeated Setbacks Since 2024 Filing
Unicycive submitted the OLC NDA in September 2024, which the FDA accepted in November 2024. After the FDA's June 2025 Complete Response Letter, the company held a Type A meeting with regulators in October 2025 to address the single cited deficiency tied to the manufacturing vendor, then resubmitted the application in December 2025 -- only for the FDA to reject it again in June 2026 on identical grounds.
Investors Face November Deadline to Seek Lead Plaintiff Role
Investors who suffered losses during the class period may pursue claims under federal securities laws and must contact Robbins LLP before the November 2, 2026 lead plaintiff deadline. The firm is representing investors on a contingency fee basis.