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 ...
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 ...
PharmExec4d
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 ...
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 ...
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 ...
Investor's Business Daily on MSN4d
Why Replimune's Surprise Rejection Rattled Wall Street, And Cratered Its Stock
Replimune stock cratered Tuesday after the Food and Drug Administration unexpectedly rejected its experimental melanoma ...
Medscape2d
FDA Declines to Approve New Melanoma Therapy
In a complete response letter, the FDA indicates the drug trial is not an adequate, well-controlled clinical investigation, ...
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: A Surprise CRL Exposes Fragility Of The Melanoma Program
Replimune Group, Inc. faces FDA setbacks with RP1, raising financial risks and dilution concerns. Click here to find out why ...
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 ...
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 ...