Lantheus Holdings announced that the U.S. Food and Drug Administration approved its new formulation of the prostate‑cancer imaging agent PYLARIFY TruVu (piflufolastat F‑18) on March 6 2026. The approval extends the company’s flagship PSMA PET imaging platform, which has already supported more than 760,000 scans since its original launch in May 2021.
The TruVu formulation improves stability at higher radioactive concentrations, enabling larger batch sizes and a more efficient manufacturing and distribution process. Lantheus expects the new product to become commercially available in the fourth quarter of 2026, with a phased geographic rollout designed to transition existing customers from the original PYLARIFY to the new formulation without disruption.
This approval reinforces Lantheus’s commitment to innovation in the radiopharmaceutical space and addresses a key market need for greater patient access. By expanding supply capacity, the company aims to counter recent price competition that has compressed net prices in the PSMA PET market and to restore revenue growth and gross‑margin performance.
"The FDA approval of PYLARIFY TruVu demonstrates Lantheus’ continued commitment to advancing innovation that directly expands patient access to high‑quality diagnostic tools," said Mary Anne Heino, Executive Chairperson and CEO. "The availability of PYLARIFY TruVu addresses a key need identified by clinicians – greater access to our market‑leading formulation."
"As we continue to innovate and expand our portfolio, ensuring a reliable and uninterrupted supply for our customers remains our top priority. The PYLARIFY TruVu formulation is designed to enhance manufacturing efficiency, strengthen supply‑chain dependability and ultimately improve the healthcare system’s ability to deliver timely, accurate imaging for people with prostate cancer," added Dorothy Barr, Senior Vice President, Manufacturing and Technical Operations.
The new formulation is expected to broaden patient access, increase batch sizes, and improve supply‑chain resilience, all of which should translate into higher sales volumes and improved gross margins. By mitigating the impact of price compression and expanding its market reach, Lantheus positions itself to sustain growth in a competitive PSMA PET landscape.
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