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Biotech / Medical : Immunomedics (IMMU) - moderated
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From: dorightbythem9/29/2025 6:04:51 PM
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What can be done, if anything, about hit job statements like this one on an approve in 2021 drug like voclosporin.

Shares of Aurinia Pharmaceuticals () were slipping after George Tidmarsh, director of the FDDA’s Center for Drug Evaluation and Research, 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,” Tidmarsh said. “While there is no doubt that the use of such endpoints has benefited patients by bringing valuable treatments to patients sooner, there have been notable failures in confirmatory trials, such as those for exon skipping therapies in DMD. And for some diseases such as lupus nephritis, companies have not run trials to demonstrate a benefit on hard clinical endpoints like progression to end stage renal disease. So we have approved drugs with significant toxicity like voclosporin that has not been shown to provide a direct clinical benefit for patients. We will be taking a close look at the use of surrogate endpoints to see where we can further accelerate promising drugs faster while requiring companies to perform the trials necessary to confirm actual clinical benefit.” Aurinia shares were down 16.4% in afternoon trading.
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