Aurinia Pharmaceuticals filed a federal lawsuit against former FDA Center for Drug Evaluation and Research director George Tidmarsh on November 2, 2025, alleging he made false statements about the safety and efficacy of its lupus nephritis drug LUPKYNIS (voclosporin).
The complaint claims Tidmarsh asserted the drug had significant toxicity and lacked evidence of benefit on hard clinical outcomes such as progression to end‑stage renal disease. It also alleges he solicited a bribe to retaliate against Aurinia chairman Kevin Tang and that he posted a now‑deleted LinkedIn comment disparaging LUPKYNIS.
Aurinia seeks damages and a court order to prevent further defamatory statements. The company says Tidmarsh’s remarks contributed to a market value loss of more than $350 million.
Aurinia reported Q3 2024 total net revenue of $67.8 million, up 24 % year‑over‑year, and net product revenue of $55.5 million, up 36 % year‑over‑year. The company posted net income of $14.4 million ($0.10 per share) for the quarter, compared with a net loss of $13.4 million ($0.09 per share) in Q3 2023. Management highlighted strong demand for LUPKYNIS and ongoing development of other assets such as AUR200.
Tidmarsh resigned from his position as CDER director on the same day the lawsuit was filed, after being placed on administrative leave on October 31, 2025. The lawsuit marks Aurinia’s formal response to the director’s allegations and underscores the company’s intent to protect its product’s reputation and regulatory standing.
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