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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 population.
The company's shares plunged as much as 78% in Tuesday trading in New York.
Replimune submitted its application in November under the FDA's accelerated approval pathway, which allows drugs for serious or life-threatening conditions to be approved based on early evidence of benefit. The company said in January that the drug had received priority review and the agency hadn't identified any potential review issues.
Replimune said in the statement that it plans to 'urgently interact with the FDA to find a path forward.'
In a note, BMO Capital Markets analyst Evan Seigerman called the FDA rejection 'the worst case scenario' for Replimune and it appeared that the new FDA leadership had a late change of opinion.
'This potential last minute change points to a changing tone at the agency, which is placing a greater emphasis on randomized controlled trials regardless of the patient population and availability of alternative treatment options,' Seigerman wrote.
Vinay Prasad, the FDA's new chief medical and scientific officer, has previously been critical of approving drugs based on uncontrolled data, he said.
In recent days, the FDA has also rejected treatments from Capricor Therapeutics Inc. and Ultragenyx Pharmaceutical Inc.
(Updates with shares trading and additional context in the fifth paragraph.)
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