Replimune Plunges After FDA Rejects Skin Cancer Drug Again (2)

Replimune Group Inc. shares plunged after US regulators rejected the company’s skin cancer treatment for a second time, a sign that they are maintaining their tough stance on drug reviews.

Replimune shares fell 58% when trading resumed after New York markets closed, following a halt earlier Friday. The Food and Drug Administration denied Replimune’s medication to treat advanced melanoma, which combined the company’s immunotherapy and another cancer drug.

The data on the company’s treatment is “insufficient to conclude substantial evidence of effectiveness,” according to a Friday letter from the FDA to the company.

Replimune disagreed with the FDA about whether ...