Recent Updates — UNCY
Unicycive Therapeutics appointed Meredith S. Manning as an independent director effective October 1, 2026, assigning her to the Audit, Compensation, and Nominating committees where she will serve as chair. The company resubmitted its New Drug Application for oxylanthanum carbonate, addressing prior Complete Response Letters by adding CMC data from a new manufacturing vendor with FDA 'No Action Indicated' status. Unicycive anticipates FDA acceptance within 30 days and expects a PDUFA date six months post-resubmission, while maintaining cash reserves of $61.4 million to support operations into the second half of 2027. The company operates in the biotechnology industry, developing therapies for kidney diseases.
On September 3, 2026, a securities class action lawsuit was filed in the United States District Court for the Northern District of California against Unicycive Therapeutics, Inc. and certain officers. The complaint alleges violations of federal securities laws related to public statements concerning the company's new drug application for oxylanthanum carbonate phosphate binder, intended for treating hyperphosphatemia in chronic kidney disease patients on dialysis. The company asserts the claims are meritless and intends to vigorously defend against them. Unicycive Therapeutics operates in the biotechnology industry, focusing on developing therapies for metabolic bone diseases.
Unicycive Therapeutics reported a net loss of $1.7 million, or $0.06 per share, for the second quarter ended June 30, 2026, compared to a $6.5 million loss in the prior year period, driven by a $8.4 million gain from the change in fair value of its warrant liability. The company holds $61.4 million in cash and marketable securities as of June 30, 2026, providing expected runway into 2027. Operationally, Unicycive received a Complete Response Letter for its New Drug Application for oxylanthanum carbonate due to manufacturing deficiencies at a third-party vendor; however, the FDA has now assigned an inspection to this facility, which is a prerequisite for resubmitting the application. The company continues commercial readiness initiatives while awaiting inspection results. Unicycive Therapeutics operates in the biotechnology industry, developing therapies for kidney diseases.
Unicycive Therapeutics reported an ending cash balance of approximately $61.4 million as of June 30, 2026, based on preliminary unaudited second-quarter results. The company operates in the biotechnology industry and develops therapeutic products.