Replimune said the agency had issued a complete response letter regarding the company’s biologics license application for RP1, its lead candidate to treat advanced melanoma in c

The FDA has rejected Replimune’s request for approval of RP1, adding the melanoma drug candidate to the list of assets to receive complete response letters from the new-look agency. Investors sent the biotech’s share price down 76% to below $3 in premarket trading.

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.