FDA Manufacturing Issues Delay Lantheus' Tumor Imaging Kit

On Friday, the U.S.

Food and Drug Administration (FDA) issued a Complete Response Letter to Lantheus Holdings Inc.’s (NASDAQ: LNTH ) New Drug Application (NDA) for LNTH-2501 (Gallium 68 edotreotide), a PET diagnostic imaging kit targeting somatostatin receptor-positive neuroendocrine tumors.

FDA Issues Complete Response Letter For Lantheus Imaging Agent The FDA stated unresolved third-party facility manufacturing-related conditions.

The third-party facility is responsible for drug product manufacturing.

Satisfactory resolution of the unresolved facility inspection-related conditions is required before the LNTH-2501 NDA may be approved.

The CRL did not identify any concerns regarding the data submitted by Lantheus in support of the application, nor did it identify any issues related to the safety or efficacy of LNTH-2501.

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 said that the standard review extension is not related to the efficacy or safety data of LNTH-2501.

Read Also: Radiopharm Theranostics Eyes Pivotal Trial Path After Encouraging Interim Results William Blair Delays Octevy Sales Forecast William Blair on Monday wrote, “While we are disappointed by the setback, we are encouraged that the complete response letter (CRL) does not appear to be clinical in nature.” In light of the CRL, analyst Andy Hsieh pushed back initial sales of Octevy by one year in the model to the first quarter of 2028 from the first quarter of 2027 previously.

Octevy is a PET diagnostic imaging agent for certain neuroendocrine tumors.

Analyst Highlights Improving Fundamentals, Growth Catalysts Taking a step back, William Blair wrote that the fundamentals for Lantheus are improving as the company navigates through challenging pricing dynamics before transitioning the market to Pylarify TruVu at the end of the year.

The analyst said that the ongoing launch of Neuraceq, coupled with the anticipated approval of MK-6240 (tau-directed diagnostic PET agent for Alzheimer’s disease ), provides multiple drivers to reinvigorate top-line growth.

LNTH Price Action: Lantheus Holdings shares were trading down 0.50% at $109.25 at the time of publication on Monday.

The stock is trading near its 52-week high of $111.46, according to Pro data.

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