Lantheus Holdings Inc. received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for LNTH-2501 (Gallium 68 edotreotide), a PET diagnostic imaging kit targeting somatostatin receptor-positive neuroendocrine tumors. The FDA stated it cannot approve the NDA by the Prescription Drug User Fee Act (PDUFA) action date of June 29, 2026, due to unresolved third-party facility manufacturing-related conditions. The third-party facility is responsible for drug product manufacturing, and satisfactory resolution of these inspection-related conditions is required before approval.

The CRL did not identify any concerns regarding the data submitted by Lantheus in support of the application. Additionally, the agency did not identify any issues related to the safety or efficacy of LNTH-2501. Mary Anne Heino, Executive Chairperson and Chief Executive Officer of Lantheus, stated that the feedback relates solely to the third-party manufacturer and not to the clinical performance of the product. The company is working closely with its partner and the agency to address the facility manufacturing-related conditions.

In March, the FDA extended the PDUFA date for LNTH-2501 by three months to June 29, 2026, to allow additional time to review manufacturing-related information. The agency stated that this standard review extension is not related to the efficacy or safety data of LNTH-2501.

Analyst Reaction

William Blair analyst Andy Hsieh pushed back initial sales of Octevy, the trade name for LNTH-2501, by one year in the model to the first quarter of 2028 from the first quarter of 2027 previously. The firm noted that while the setback is disappointing, they are encouraged that the CRL does not appear to be clinical in nature. William Blair highlighted that the fundamentals for Lantheus are improving as the company navigates pricing dynamics and transitions the market to Pylarify TruVu.

Key Details of the CRL

LNTH-2501 (Kit for Preparation of Ga 68 edotreotide Injection) is an investigational radioactive diagnostic kit indicated for use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients. It is supplied as a 2-vial kit to radiopharmacies, allowing for direct preparation of Ga 68 edotreotide injection with the eluate of Gallium from an on-site generator. LNTH-2501 is not currently approved by the FDA and is not yet available for sale in the United States.

Citizens analyst David Turkaly has reaffirmed a Market Outperform rating for Lantheus Holdings, maintaining a price target of $115. The rating reiteration underscores the firm's continued confidence in the company's market performance.

Analyst Rating and Price Target

The research note from Citizens highlights the following key details regarding Lantheus Holdings:

The stock is listed on the NASDAQ under the ticker symbol LNTH.