Key Takeaways:
- FDA issued CRL for Lantheus's LNTH-2501 three days before PDUFA date
- CRL cites third-party manufacturing issues, not safety or efficacy
- Lantheus shares traded near $109.64, up 64% year-to-date
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Lantheus receives FDA CRL for NET imaging drug LNTH-2501
Lantheus Holdings received a Complete Response Letter from the FDA for LNTH-2501, its PET imaging agent for neuroendocrine tumors, three days before the June 29 PDUFA date.
"The feedback received from the FDA relates solely to our third-party manufacturer, and not to the clinical performance of the product," Mary Anne Heino, Executive Chairperson and Chief Executive Officer at Lantheus, said.
The FDA cited unresolved third-party facility manufacturing-related conditions as the reason for the CRL. The agency did not identify any concerns regarding the safety or efficacy data submitted in the application. LNTH-2501 (Gallium 68 edotreotide) is a two-vial kit supplied to radiopharmacies for direct preparation with gallium eluate from an on-site generator, used with PET to localize somatostatin receptor-positive neuroendocrine tumors in adult and pediatric patients.
Lantheus shares traded at $109.64, near their 52-week high, with the stock up 64% year-to-date before the announcement. The company holds a $7.2 billion market capitalization and reported $1.55 billion in revenue over the last twelve months. In the first quarter of 2026, Lantheus posted adjusted earnings per share of $1.46 on revenue of $377.3 million, both above consensus estimates. Bloomberg reported in recent weeks that Lantheus is considering a sale to Curium in a potential deal valued at approximately $7 billion.
The CRL delays Lantheus's entry into the neuroendocrine tumor imaging market, where LNTH-2501 would have competed with established somatostatin receptor PET agents. The company said it is working with its third-party manufacturing partner and the FDA to resolve the facility conditions. LNTH-2501 is not yet approved or available for sale in the United States.
This article is for informational purposes only and does not constitute investment advice.
