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.

The Food and Drug Administration on Tuesday rejected a viral-based treatment from Replimune Group intended for patients with advanced skin cancer — a decision that again signals a hardened stance on drug approvals from Vinay Prasad, the agency’s top regulator of cell and gene therapies. 

The FDA declined to approve the Replimune drug, called RP1, because the company’s clinical trial was “not considered to be an adequate and well-controlled clinical investigation that provides substantial evidence of effectiveness,” the company said in a statement. 

Data from the study could not be “adequately interpreted due to the heterogeneity of the patient population,” the company said the FDA reported.

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