Shares of Replimune crashed nearly 32% on Tuesday after its lead skin cancer therapy came under fresh scrutiny, with FDA staff reviewers stating the company has not provided clear evidence that the drug works as claimed. The stock also fell below its 100-day moving average for the first time in nearly two months and is down 32% so far this year.1What Does the FDA take issue with? According to Replimune, some patients achieved complete disappearance of their tumors. FDA also says the overall survival data submitted by Replimune cannot be reliably interpreted to show a treatment benefit. The latest review adds to a difficult regulatory history for Replimune.