Top FDA regulator’s unusual criticism of therapy gets Wall Street wagging

Adam Feuerstein is a senior writer and biotech columnist, reporting on the crossroads of drug development, business, Wall Street, and biotechnology. He is also a co-host of the weekly biotech podcast The Readout Loud and author of the newsletter Adam’s Biotech Scorecard. You can reach Adam on Signal at stataf.54.

Is George Tidmarsh, the Food and Drug Administration’s top regulator, trying to exact revenge on a prominent Wall Street investor after a run-in with him six years ago? 

It’s the question biotech investors were wagging about all Monday after Tidmarsh used his personal LinkedIn page to raise questions about the safety of voclosporin, a rather obscure drug the FDA approved in 2021 to treat patients with lupus nephritis, a type of autoimmune disease that damages the kidneys. 

Voclosporin has “significant toxicity,” Tidmarsh wrote in his LinkedIn post, adding that the drug “has not been shown to provide a direct clinical benefit for patients.”