Shares of Replimune Group cratered on Tuesday after the biotech said the U.S. Food and Drug Administration rejected an application seeking approval of its experimental skin cancer treatment.
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 conjunction with nivolumab from Bristol Myers Squibb.
While the FDA didn’t raise any safety issues, the agency indicated it wouldn’t be able to approve the application in its current form, Replimune said.
Shares fell 75% to $3.04, putting the stock on track for a record closing low, according to Dow Jones Market Data. The stock traded as low as $2.68 in early Tuesday trading, marking an all-time intraday low.
The FDA took issue with the “Ignyte” trial used to evaluate the efficacy of the drug, saying it was “not considered to be an adequate and well-controlled clinical investigation that provides substantial evidence of effectiveness.”
The agency also cited concerns about patient heterogeneity, pointing to a lack of diversity within the patient population.
Replimune said it would request a Type A meeting with the FDA, which is meant to help a stalled drug development program proceed. The request should be granted within 30 days, the company added.
“We are surprised by this FDA decision and disappointed for advanced melanoma patients who have limited treatment options,” CEO Sushil Patel said. He asserted that the issues highlighted in the FDA’s letter “were not raised by the agency during the mid- and late-cycle reviews.”
The company remains confident that RP1 in combination with nivolumab “can bring substantial benefit to advanced melanoma patients,” Patel added.
Write to Mackenzie Tatananni at mackenzie.tatananni@barrons.com
