The filed complaint alleges that Unicycive Therapeutics, Inc. made materially false and/or misleading statements and/or failed to disclose that: (i) Unicycive’s readiness and ability to satisfy the FDA’s manufacturing compliance requirements was overstated; (ii) the oxylanthanum carbonate new drug application’s regulatory prospects were likewise overstated; and (iii) as a result, defendants’ public statements were materially false and misleading at all relevant times.