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Lantheus : FDA Approves PYLARIFY TruVu, New PSMA Imaging Agent For Prostate Cancer

By RTTNews Staff Writer   ✉   | Published:   | Follow Us On Google News

Lantheus Holdings Inc. (LNTH) announced that the U.S. Food and Drug Administration has approved PYLARIFY TruVu (piflufolastat F 18) injection, a new formulation of its F 18 prostate-specific membrane antigen (PSMA) imaging agent.

PYLARIFY TruVu is indicated for positron emission tomography (PET) imaging of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy or suspected recurrence based on elevated serum prostate-specific antigen (PSA) level.

PYLARIFY TruVu is expected to be commercially available in the fourth quarter of 2026 and will be introduced on a rolling geographic basis, allowing customers to transition from PYLARIFY to the new formulation with minimal disruption.

LNTH ended regular trading at $72.56, down $3.75 or 4.91% by the close at 4:00:02 PM EST. In after-hours trading, the stock showed a slight recovery, edging up to $72.62, a modest gain of $0.06 or 0.08%.

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