Lantheus Holdings: Tensions From The PDUFA Extension

Lantheus Holdings faces a three-month FDA PDUFA extension for OCTEVY, delaying potential approval and launch to June 2026. OCTEVY's extension is procedural, tied to manufacturing review, not efficacy or safety, and is not expected to impact its clinical adoption pathway. While OCTEVY alone won't restore double-digit growth, it can stabilize near-term revenue and support LNTH's strategic pivot to PET radiodiagnostics.