News

Replimune rebounds despite analyst downgrades on FDA rejection
Replimune (REPL) stock rebounds even as FDA rejection of its RP1 skin cancer drug lead to multiple analyst downgrades on Wall Street. Read more here.
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., ...
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 ...
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 ...
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 ...
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 ...
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 (NCT03767348) trial in advanced melanoma was not ...
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 ...
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 ...
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.
BioPharma Dive4d
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.