Unicycive Therapeutics IncFDA issued second Complete Response Letter for kidney disease therapy, citing manufacturing deficiencies, causing 39% stock drop.

The law firm Kirby McInerney LLP is investigating Unicycive Therapeutics on behalf of investors concerning possible violations of federal securities laws. The investigation follows Unicycive's June 30, 2026 announcement that the FDA issued a second Complete Response Letter for its kidney disease therapy drug application, citing the same third-party manufacturing deficiencies identified in a prior June 2025 letter. On that news, Unicycive's share price fell $3.01, or approximately 39%, from $7.70 on June 29, 2026 to close at $4.69 on June 30, 2026. No lawsuit has been filed at this stage, and the investigation is ongoing to determine whether claims may be brought.
Unicycive Therapeutics IncFDA issued second Complete Response Letter for kidney disease therapy, citing manufacturing deficiencies, causing 39% stock drop.