Lantheus announced that the U.S. Food and Drug Administration has set a Prescription Drug User Fee Act (PDUFA) target action date of March 29, 2026 for its LNTH‑2501 diagnostic kit, a Gallium‑68 edotreotide product designed to image somatostatin‑receptor‑positive neuroendocrine tumors.
The kit will allow radiopharmacies to prepare the radiopharmaceutical on site using a generator, providing clinicians with a PET imaging tool that offers higher sensitivity for detecting neuroendocrine tumors compared with existing modalities.
The announcement follows Lantheus’ recent Q1 2024 financial results, in which worldwide revenue reached $370.0 million, up 23.0% from Q1 2023. PYLARIFY net product sales were $258.9 million, a 32.4% increase, while DEFINITY net product sales were $76.6 million, up 11.2%.
Lantheus’ strategy to become a fully integrated radiopharmaceutical leader includes the LNTH‑2501 launch, which would diversify its portfolio beyond PSMA PET agent PYLARIFY and ultrasound agent DEFINITY. The company also continues to pursue strategic acquisitions and has recently divested its SPECT business.
The company faces headwinds, including a securities fraud class action alleging misrepresentations about PYLARIFY’s competitive position. Nonetheless, the growing neuroendocrine tumor imaging market, projected to reach $7.26 billion by 2034, supports the potential impact of LNTH‑2501.
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