Responding to a now retracted LinkedIn post referencing voclosporin by an FDA official, Aurinia Pharmaceuticals Inc. (AUPH) stated that it stands firmly behind the favorable benefit/risk profile of LUPKYNIS (voclosporin). The drug received full FDA approval in January 2021, supported by data from AURORA 1—a large, randomized 52-week clinical trial. In April 2024, the FDA further approved a supplementary new drug application for long-term use of LUPKYNIS, based on AURORA 2 results, which confirmed sustained efficacy over three years and a safety profile consistent with AURORA 1.
Earlier today, George Tidmarsh, director of the FDA's Center for Drug Evaluation and Research, reportedly said in a LinkedIn post that the company's voclosporin, which was approved by the FDA in 2021, has "significant toxicity" and has not been shown to have a positive impact on patients. CDER will be evaluating surrogate endpoints used for FDA approval.
AUPH closed Monday's regular trading at $11.06 down $2.08 or 15.83%. But in the After hours trading the stock gained $0.81 or 7.32%.
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Business News
May 15, 2026 15:25 ET Apart from the confirmation of Kevin Warsh as the next Fed chair, the main news on the economics front this week included key price data from the U.S. and the first quarter economic growth figures from major economies. Both consumer prices and producer costs have started to reflect the effect of supply shocks due to the Middle East conflict. In Europe, GDP data was in focus, while inflation data from China dominated the news flow in Asia.