News

Replimune Stock Plummets 75% After FDA Rejects Application for Skin Cancer Treatment
Replimune said the agency had issued a complete response letter regarding the company’s biologics license application for RP1 ...
Fierce Biotech4d
Replimune's shares crater as FDA rejects melanoma drug
The FDA has rejected Replimune’s request for approval of RP1, adding the melanoma drug candidate to the list of assets to ...
Applied Clinical Trials Online4d
FDA Issues Complete Response Letter to Replimune for RP1 Combination Therapy in Advanced Melanoma
The FDA’s complete response letter cited concerns that the Phase I/II IGNYTE (CT03767348) trial in advanced melanoma was not ...
Iovance climbs after FDA rejection for Replimune’s skin cancer drug
The FDA’s decision to reject Replimune’s (NASDAQ:REPL) lead asset RP1 for a type of skin cancer known as melanoma appears to ...
Replimune plunges as FDA rejects its lead drug for skin cancer
Replimune (REPL) stock in focus as the FDA rejects its lead drug RP1 as part of a combination regimen for melanoma, a type of ...
Replimune Receives Complete Response Letter from FDA for RP1 Biologics License Application for the Treatment of Advanced Melanoma
Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced that the U.S. Food and Drug Administration ...
STAT4d
Replimune skin cancer therapy rejected by FDA, a sign of regulators’ hardened stance
The FDA on Tuesday rejected a skin therapy from Replimune Group, suggesting a hardened stance on drug approvals under new ...
PharmExec1d
Replimune CRL Fallout: How Biopharma Leaders Should Manage a New Layer of FDA Uncertainty
A deep dive into the implications of the Replimune CRL that surprised insiders and investors, the role of new leadership at ...
Managed Healthcare Executive4d
FDA Delays Approval of Replimune’s Melanoma Therapy Despite Promising Trial Results
Replimune's RP1 treatment for advanced melanoma faces FDA rejection due to trial design issues, despite promising results ...
Applied Clinical Trials Online1d
FDA Crackdown on Trial Design: What July’s CRLs to Replimune and Capricor Mean for Sponsors
Complete Response Letters recently issued by the FDA signal heightened scrutiny of trial design and reinforce the agency’s shifting regulatory expectations for sponsors and CROs.
Replimune: FDA Rejects Application Seeking RP1 Approval
Replimune, which was seeking approval of RP1 in combination with Bristol Myers Squibb's Opdivo for the treatment of advanced melanoma, on Tuesday said the FDA issued a so-called complete response ...