Lantheus Holdings, Inc. (LNTH) Announces FDA Approval of its New Drug Application for F 18 PSMA Imaging Agent

With a price-to-earnings multiple under 15x and its relative strength index below 40, Lantheus Holdings, Inc. (NASDAQ:LNTH) secures a spot on our list of the 13 Oversold Value Stocks to Invest in Now.

Lantheus Holdings, Inc. (NASDAQ:LNTH) announced on August 6, 2025, that the FDA approved a New Drug Application (NDA). This NDA, filed by its affiliate Aphelion, relates to a new formulation of its F 18 PSMA imaging agent. The Prescription Drug User Fee Act (PDUFA) date is set for March 6, 2026.

This development follows the successful launch of PYLARIFY, which is Lantheus Holdings, Inc. (NASDAQ:LNTH)‘s market-leading PSMA PET imaging agent. PSMA has shown an 86% median true-positive rate in recurrent prostate cancer detection.

With the new formulation, Lantheus Holdings, Inc. (NASDAQ:LNTH) expects to boost manufacturing efficiency, increasing batch sizes by roughly 50%, potentially improving patient access and geographic reach. With this development, LNTH takes a step forward in sustainable innovation and advancing prostate cancer imaging.

Lantheus Holdings, Inc. (NASDAQ:LNTH), a radiopharmaceutical-focused company, delivers diagnostic and therapeutic solutions to improve disease detection, treatment, and patient outcomes globally. It is one of the oversold stocks.

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Disclosure: None.