Unicycive Therapeutics Inc. leaders are responsible for misrepresenting that its manufacturing arrangements for a chronic kidney disease treatment under FDA review would meet the agency’s requirements, an investor alleges.
The directors and top executives overstated Unicycive’s readiness and ability to satisfy that aspect of the Food and Drug Administration’s new-drug review process, Tacarra Jackson says on behalf of the company. She filed her derivative suit Thursday in the US District Court for the Northern District of California.
Because of those representations, the biotechnology company’s stock suffered a jolt when the FDA issued a “complete response letter” indicating the review cycle ...