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Investor's Business Daily on MSN3d
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 ...
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 ...
FDA Rejects Replimune’s Skin Cancer Treatment, Shares Sink
Replimune Group Inc. shares sank to their lowest point ever after US regulators rejected a skin cancer treatment from the ...
PharmExec10h
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 ...
STAT3d
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 ...
Fierce Biotech3d
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 ...
Managed Healthcare Executive3d
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 ...
BioPharma Dive3d
Replimune drug rejected by FDA; Omega raises $647M biotech fund
Analysts questioned whether the complete response letter Replimune received was evidence of changing approval standards at the FDA.
Replimune Shares Plumb All-Time Lows After FDA Rejection
Replimune shares collapsed on Tuesday after the U.S. Food and Drug Administration rejected the clinical-stage biotechnology company's proposed advanced melanoma treatment. Shares of the Woburn, Mass., ...
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 ...
Healio3d
FDA rejects RP1 for advanced melanoma, says IGNYTE not a ‘well-controlled’ trial
The FDA has issued a complete response letter to Replimune indicating it is unable to approve the biologics license ...
Applied Clinical Trials Online10h
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.