FDA Accepts Lantheus Holdings, Inc. (LNTH)' NDA for New PSMA Imaging Agent

We recently compiled a list of the 11 Best Pharma Stocks to Invest in for the Long Term. Lantheus Holdings, Inc. is placed sixth among them.

Lantheus Holdings, Inc. (NASDAQ:LNTH), a leader in radiopharmaceuticals, is strengthening its position in diagnostic and therapeutic imaging with several recent milestones. The company’s focus on innovation and growth highlights its expanding role in advancing precision medicine.

A major development came as the FDA accepted Lantheus Holdings, Inc. (NASDAQ:LNTH)’ New Drug Application for a more efficient formulation of its F 18 PSMA PET imaging agent, with a PDUFA date set for March 6, 2026. The updated formulation is expected to boost batch size by roughly 50%, enhancing supply resilience and patient access to prostate cancer diagnostics.

In parallel, the business completed its acquisition of Life Molecular Imaging, a move that broadens its molecular imaging pipeline and research capabilities. The integration will be led by Dr. Ludger Dinkelborg, the newly appointed Head of R&D, who is expected to drive innovation across the expanded portfolio.

On the financial front, the corporation launched a $400 million share repurchase program, underscoring confidence in long-term growth and delivering a direct commitment to shareholders.

While competitive pricing pressures remain a headwind in the PSMA diagnostic market, Lantheus Holdings, Inc. (NASDAQ:LNTH) reported 2% domestic volume growth for its flagship PYLARIFY product, demonstrating resilient demand. With its regulatory progress and pipeline expansion, the company continues to position itself among the best pharmaceutical stocks, combining innovation and shareholder value. The combination of regulatory progress, pipeline expansion, and strategic financial initiatives positions the company to sustain momentum in 2025 and beyond.

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