Replimune Group Inc. (REPL)
REPL Stock Soars on Plans of BLA Resubmission for Melanoma Combo Drug
Replimune stock surges after the company aligned with the FDA on plans to resubmit its BLA for RP1 plus Opdivo in advanced melanoma.
How Replimune's drug got a third chance after the White House intervened
Replimune representatives met with White House officials in early May and by the end of month, the Food and Drug Administration was planning to review the melanoma medication again.
Replimune to resubmit twice-rejected drug for approval after FDA shakeup
Replimune said it plans to resubmit its melanoma drug for approval following two earlier rejections. The move follows the departure of Food and Drug Administration Commissioner Marty Makary.
Replimune reaches agreement with US FDA to resubmit melanoma drug application
Replimune said on Friday it it has reached an agreement with the U.S. Food and Drug Administration to resubmit the marketing application for its experimental skin cancer drug after the regulator twice declined to approve the therapy.
Replimune Gets Third Try at FDA Approval After Makary Departure
Experimental melanoma drug was rejected twice because the Food and Drug Administration questioned its study design.
Replimune: Perhaps The FDA Shakeup Will Get A Mulligan For RP1
Replimune Group, Inc.'s RP1 has failed at the FDA twice, but Makary's resignation keeps a resubmission possible. REPL's cash runway stands at under a year; workforce cuts and RP1 discontinuation are being considered. I maintain a cautious Buy on the ability for REPL to court surprising, bold turnarounds. I don't think this story is over.
US Health Secretary Kennedy distances himself from FDA's Replimune cancer drug rejection
Health Secretary Robert F. Kennedy Jr. told a Senate hearing on Wednesday that he had nothing to do with the U.S. FDA's decision to not approve Replimune's drug for advanced skin cancer, saying it was in the hands of the agency's Commissioner Dr. Marty Makary.
Replimune Gets Second FDA CRL for Melanoma Drug BLA, Stock Crashes
REPL stock plunges after a second FDA CRL delays RP1 melanoma approval, casting doubt on its regulatory path and near-term growth plans.
Replimune melanoma therapy rejected by FDA, shares plunge
Replimune Group (NASDAQ:REPL) shares fell roughly 63% following the company's disclosure that it received a Complete Response Letter (CRL) from the US Food and Drug Administration, effectively blocking the approval of its lead melanoma therapy RP1 in combination with nivolumab. The decision represents a significant setback for the biotechnology company, which had been seeking approval based on data from its IGNYTE clinical program in patients with advanced melanoma who had progressed on prior anti-PD-1 therapy.
Does Replimune Group (REPL) Have the Potential to Rally 79.61% as Wall Street Analysts Expect?
The mean of analysts' price targets for Replimune Group (REPL) points to a 79.6% upside in the stock. While this highly sought-after metric has not proven reasonably effective, strong agreement among analysts in raising earnings estimates does indicate an upside in the stock.
Replimune Group, Inc. (REPL) Presents at 44th Annual J.P. Morgan Healthcare Conference Transcript
Replimune Group, Inc. (REPL) Presents at 44th Annual J.P. Morgan Healthcare Conference Transcript
Here's Why Replimune Stock Skyrockets Nearly 131% in 3 Months
REPL shares soar 131.1% over the past three months after the FDA accepts its resubmitted BLA for the RP1/Opdivo combo in advanced melanoma.
