The litigation centers on a period between December 29, 2025, and June 29, 2026. Throughout these months, Unicycive executives maintained that the resubmission of its 505(b)(2) application was progressing based on improvements at its manufacturing vendor. However, when the FDA issued a second Complete Response Letter on June 30, 2026, it revealed that the same manufacturing issues from June 2025 remained unresolved. The company subsequently disclosed that it had not conducted its own inspections of the vendor's facility during the review period, relying instead on the vendor’s own assurances.
Unicycive Therapeutics Faces Class Action Over OLC Approval Delays
A federal class action lawsuit alleges that Unicycive Therapeutics misled shareholders for six months regarding the status of its oxylanthanum carbonate (OLC) application. The complaint claims the company repeatedly assured investors the project was on track without ever verifying that its third-party manufacturer had resolved critical FDA-cited deficiencies.
The market reaction was swift. After closing at $7.70 on June 29, UNCY shares plummeted 39.1% the following session, shedding $3.01 to finish at $4.69 on heavy trading volume. Joseph E. Levi of Levi & Korsinsky LLP, the firm representing the plaintiffs, noted that the sequence of disclosures raises significant questions about the company’s due diligence process before reporting to the public. Investors who purchased shares during the specified class period have until November 2, 2026, to seek lead plaintiff status in the United States District Court for the Northern District of California.
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