LNTH Lantheus

Lantheus updates HSR review timeline for Curium acquisition

Lantheus and Curium voluntarily withdrew and refiled their HSR notification. This starts a new 30-day waiting period ending October 21, 2026. The parties continue to expect to close the acquisition in the first half of 2027, subject to regulatory approvals and other conditions.

Lantheus receives CRL for LNTH-2501 (Ga 68 edotreotide) NDA

FDA issued a Complete Response Letter on June 26, 2026, declining to approve the NDA by the June 29, 2026 PDUFA date. The CRL cites unresolved third-party manufacturing facility conditions; no clinical, safety, or efficacy deficiencies were identified. Approval is now contingent on satisfactory resolution of the facility inspection issues.

Lantheus: FDA approves PYLARIFY TruVu (piflufolastat F18)

FDA granted full approval for PYLARIFY TruVu, a new formulation of the company’s PSMA PET imaging agent. A phased geographic commercial launch is planned to begin in Q4 2026, aligning with coding, coverage, payment, and PMF readiness. The approval enhances manufacturing efficiency and supply flexibility.

Lantheus: FDA sets PDUFA dates for three PET imaging agents

The FDA has set three new PDUFA target action dates: March 6 2026 for the new piflufolastat F 18 PSMA PET formulation, March 29 2026 for LNTH-2501 (Ga 68 edotreotide kit for SSTR+ NETs), and August 13 2026 for MK-6240 (F 18 tau PET agent). These dates establish the next regulatory milestones for Lantheus’ radiopharmaceutical pipeline.