Why Replimune Shares Dropped Despite FDA Nod for Melanoma Drug TUDRIQEV
Investors reacted to the 24.2% ORR on the official label.
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Leerink Upgrades Replimune to Outperform, Sees High Odds of FDA Approval for Melanoma Therapy
Leerink upgrades Replimune to Outperform with $17 target, citing high odds of FDA accelerated approval for RP-1 melanoma therapy after 10-3 vote.
FDA Panel Backs Replimune’s Melanoma Drug After Multiple Rejections
FDA panel votes 10-3 for Replimune’s RP1 melanoma drug after two rejections, citing benefits for resistant patients despite messy data.
FDA Raises Serious Doubts Over Replimune’s RP1 Melanoma Therapy Ahead of Key Panel
FDA briefing docs criticize Replimune’s RP1 trial data, raising doubts over effectiveness and sending shares down ahead of Thursday’s panel.
Capricor Shares Plunge After FDA Briefing Documents Raise Doubts on Deramiocel
FDA briefing documents for Capricor’s deramiocel question effectiveness and highlight safety risks ahead of the July 29 advisory committee.
Replimune Stock Gets BMO Upgrade to Outperform as FDA De-Risks RP1 Approval
PDUFA date set for August 2, 2026.