Clinical TrialsReplimune will likely need to re-run its clinical studies to get to approval and may not have enough cash on its books to get there, in our view.
Financial OutlookAnalysts adjust the rating of shares to Underperform and cut the target price to $2/share, reflecting uncertainty at the new FDA and the cash required to re-run studies.
Market Entry DelaysRP1's potential U.S. market entry has been pushed back to 2029, while its probability of approval has been lowered to 50% from the prior 95%.
Regulatory ChallengesThe FDA has issued a Complete Response Letter regarding the Biologics License Application for RP1 in anti-PD-1-failed melanoma, which is likely a negative surprise for many investors.