FDA Pushes Back Its Review of New PET Imaging Agent From Lantheus

Why It Matters

The postponement pushes back the market entry of a niche oncology imaging tool, delaying potential revenue and affecting investors, while the reassurance on safety keeps the product’s clinical promise intact.

Summary

The U.S. FDA has extended its review of Lanteus’ PET imaging agent LNTH‑2501 by three months, moving the PDUFA target date to June 29. LNTH‑2501, a Ga‑68 edotreotide kit for detecting neuroendocrine tumors in adults and children, remains unapproved and unavailable for sale. Lantheus says the delay is unrelated to safety or efficacy and still expects a Q3 launch with projected sales of $2 million in Q3 and $5 million in Q4. The news nudged Lantheus shares lower, trading around $80.45.