Unicycive ($UNCY) FDA Manufacturing Failures and OLC Approval Misrepresentation Case

• $UNCY investors filed a claim against Unicycive Therapeutics for overstating its readiness to meet FDA manufacturing standards and exaggerating the regulatory prospects of its lead drug candidate oxylanthanum carbonate (OLC).

• After the FDA flagged cGMP deficiencies on June 10, 2025, halting label discussions, $UNCY fell nearly 41%. Then, on June 30, 2025, the FDA issued a Complete Response Letter citing those same deficiencies, driving the stock down another 30%.

• $UNCY investors can join this case to be notified about potential recovery.

Case Details:

Between March 29, 2024, and June 27, 2025, Unicycive repeatedly told investors it was well-positioned for FDA approval of OLC, assuring the market that its manufacturing and compliance controls were strong. Executives highlighted progress on the New Drug Application (NDA) and downplayed risks tied to reliance on third-party manufacturing.

In truth, the company faced undisclosed compliance vulnerabilities. The FDA identified serious deficiencies at a subcontractor facility, delaying label discussions and jeopardizing approval. On June 10, 2025, Unicycive disclosed the FDA’s findings, sending shares tumbling nearly 41%. Just weeks later, on June 30, 2025, the FDA issued a Complete Response Letter rejecting the NDA due to those unresolved deficiencies. Shares fell another 30%, compounding investor losses.

Based on these events, $UNCY investors filed a claim against Unicycive, alleging the company:

• It misrepresented its readiness to meet FDA standards.

• It concealed risks tied to subcontractor compliance failures.

• It artificially inflated its stock price by exaggerating the likelihood of OLC approval.

Investors argue Unicycive misled the market about its regulatory and manufacturing readiness to sustain its valuation.