Lantheus Holdings 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 Gallium‑68 edotreotide PET diagnostic kit, LNTH‑2501, a kit that prepares Ga‑68 edotreotide injection for imaging somatostatin‑receptor‑positive neuroendocrine tumors in adult and pediatric patients.
The company’s most recent earnings report showed a year‑over‑year decline in revenue and adjusted net income, prompting a revision of 2025 guidance. Operating profit fell as the company invested heavily in research and development and faced margin pressure from competitive pricing in its flagship PSMA PET imaging product, PYLARIFY. Despite the decline, management highlighted continued demand for PET diagnostics and the strategic importance of LNTH‑2501 in diversifying revenue streams.
Lantheus has faced competitive headwinds for PYLARIFY, including pricing challenges and a class action lawsuit alleging securities fraud related to statements about the product’s competitiveness. The lawsuit covers the period from February 26, 2025 to August 5, 2025, with a shareholder deadline of November 10, 2025. These legal and market pressures underscore the significance of expanding the company’s portfolio with new assets such as LNTH‑2501.
In addition to LNTH‑2501, Lantheus is advancing other pipeline assets, including a therapeutic candidate, PNT2003, and an Alzheimer’s disease diagnostic agent, MK‑6240, which has a PDUFA date of August 13, 2026. The company’s strategy to broaden its radiopharmaceutical pipeline aligns with its goal of achieving double‑digit revenue growth starting in 2026, positioning LNTH‑2501 as a key driver of future growth.
The content on BeyondSPX is for informational purposes only and should not be construed as financial or investment advice. We are not financial advisors. Consult with a qualified professional before making any investment decisions. Any actions you take based on information from this site are solely at your own risk.