Replimune Group Inc. (REPL)
Here's Why Replimune Stock Skyrockets Nearly 223% in 3 Months
REPL's RP1 secures FDA approval for advanced melanoma, easing regulatory uncertainty. The company expands its oncolytic immunotherapy pipeline.
Replimune Wins FDA Skin Cancer Drug Approval on Third Try. Why the Stock Is Tumbling.
Replimune secures FDA approval for Tudriqev on its third attempt, making it the company's first product on the market.
Replimune Group, Inc. (REPL) Shareholder/Analyst Call Transcript
Replimune Group, Inc. (REPL) Shareholder/Analyst Call Transcript
A Food and Drug Administration advisory panel voted 10-3 for Replimune Group's experimental melanoma therapy, after experts raised doubts about whether the company's data and trial design could be trusted to show the drug works
Independent experts voted 10-3 despite regulators' concern about the design of the company's pivotal cancer trial.
Replimune: Stock Buoyant On Third Try At RP1 Approval - FDA AdCom May Be Crucial
Replimune Group, Inc. faces a pivotal FDA AdCom for RP1 after two prior rejections, with a final FDA approval decision expected August 2, 2026. RP1 demonstrated a 34% ORR and median overall survival of 32.9 months in anti-PD-1-failed melanoma, but trial design concerns persist. REPL stock has surged over 135% since April as FDA leadership changes and collaborative dialogue opened a path for BLA resubmission.
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.
