Replimune Sinks After FDA Rejects Skin Cancer Treatment (1)

Replimune Group Inc.shares sank to their lowest point ever after US regulators rejected a skin cancer treatment from the biotech company, another sign of the agency’s new leadership taking a hard line on drug approvals.

The US Food and Drug Administration denied the company’s application to treat advanced melanoma with a combination of its immunotherapy and another cancer drug.

The agency said the company’s trial “is not considered to be an adequate and well-controlled clinical investigation that provides substantial evidence of effectiveness,” Replimune wrote in a statement. The FDA also had issues with the company’s trial design and patient ...