By Elias Schisgall
Replimune Group criticized a Food and Drug Administration decision to deny its application for a melanoma treatment in a review process that the clinical-stage biotechnology company said was marked by inconsistencies and poor communication.
The company said Friday that it disagreed with the FDA's assessment that clinical trial data doesn't show substantial evidence that RP1, also known as vusolimogene oderparepvec, is effective in treating advanced melanoma.
Replimune also said the FDA, in its complete response letter, seems to have contradicted positions it expressed at a Type A meeting in September, including about trial design and tumor assessment methodology.
The CRL showed that the FDA appointed a different team to review the company's resubmitted biologics license application for RP1 after an initial application was rejected in July, Replimune said, which declined to meet with the company during the review process.
"The country's foremost melanoma specialists stood behind the RP1 data. Patients and caregivers pleaded for urgency," Chief Executive Officer Sushil Patel said. "All of it was met with inconsistent communication and a fragmented and slow-moving regulatory process which clearly puts U.S. innovation at risk."
As a result of the FDA's decision, Patel said the company will be forced to cut jobs and scale back manufacturing in the U.S.
The FDA did not immediately respond to a request for comment.
The agency submitted its complete response letter earlier on Friday, and said that the evidence submitted does not meet the necessary standards for regulatory approval. Additional exploratory analysis provided by Replimune did not change its prior conclusion that RP1 had no substantial evidence of effectiveness, the FDA said.
Shares of Replimune fell 46% to $2.57 in after-hours trading. The stock closed down 19% at $4.76 and is down 51% this year.
Write to Elias Schisgall at elias.schisgall@wsj.com
(END) Dow Jones Newswires
04-10-26 1820ET
