GlobeNewsWire
11 Jul 2026, 00:00 UTC · 3h ago
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The FDA issued a second Complete Response Letter (CRL) rejecting Unicycive Therapeutics' resubmitted application for oxylanthanum carbonate due to persistent third-party manufacturing deficiencies. — A second CRL for the same issues suggests a significant failure in the company's ability to remedy manufacturing problems, delaying or blocking the path to commercialization for its primary drug candidate.
-0.90The law firm Kirby McInerney LLP is investigating Unicycive Therapeutics for potential violations of federal securities laws and unlawful business practices. — The prospect of securities litigation creates additional legal overhang and potential financial liability for the company beyond the drug failure.
-0.40Unicycive Therapeutics' share price fell approximately 39% on June 30, 2026, following the FDA announcement. — This confirms the market has already priced in a large portion of the negative news, though it establishes a new, lower baseline for valuation.
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The company received a second FDA Complete Response Letter and is under investigation by a law firm for potential securities law violations.
The company is mentioned in the context of an investor alert from a law firm regarding potential securities claims.
The company is mentioned as being under investigation by a plaintiffs' law firm.
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