Lantheus

LNTH

Market cap $5.46B

Lantheus Holdings faces a three-month FDA PDUFA extension for OCTEVY, delaying potential approval and launch to June 2026. OCTEVY's extension is procedural, tied to manufacturing review, not efficacy or safety, and is not expected to impact its clinical adoption pathway. While OCTEVY alone won't restore double-digit growth, it can stabilize near-term revenue and support LNTH's strategic pivot to PET radiodiagnostics.

BEDFORD, Mass., March 17, 2026 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. (“Lantheus” or “Company”) (NASDAQ: LNTH), the leading radiopharmaceutical-focused company committed to enabling clinicians to Find, Fight and Follow disease to deliver better patient outcomes, announced today that the U.S. Food and Drug Administration (FDA) has extended its review of the New Drug Application (NDA) for LNTH-2501 (Gallium 68 edotreotide) by three months to June 29, 2026.

Although its adjusted net income dipped, it handily beat analyst expectations on both the top and bottom lines. It also announced a very sensible pivot in its business.

New formulation of its widely-used U.S. market-leading PSMA PET imaging agent combines the diagnostic performance of PYLARIFY® (piflufolastat F 18) with the potential for larger batches and greater patient availability

NEW YORK CITY & NEW ORLEANS--(BUSINESS WIRE)--Former Attorney General of Louisiana, Charles C. Foti, Jr., Esq., a partner at the law firm of Kahn Swick & Foti, LLC (“KSF”), announces that KSF has commenced an investigation into Lantheus Holdings, Inc. (NasdaqGM: LNTH). In August of 2025, contrary to the Company's prior optimistic outlook for the growth potential of its flagship product, Pylarify, the Company disclosed an 8% year-over-year decline in Pylarify revenue, as well as cuts to its.

Lantheus Holdings, Inc. (LNTH) Q4 2025 Earnings Call Transcript

BEDFORD, Mass., Feb. 26, 2026 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. (Lantheus or the Company) (NASDAQ: LNTH), the leading radiopharmaceutical-focused company committed to enabling clinicians to Find, Fight and Follow disease to deliver better patient outcomes, today reported financial results for its fourth quarter and full year ended December 31, 2025.

BEDFORD, Mass., Feb. 12, 2026 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. (the “Company”) (NASDAQ: LNTH) today announced that it will host a conference call and webcast at 8:00 a.m. ET on Thursday, February 26, 2026, to discuss its financial and operating results for the fourth quarter and full year of 2025.

NEW YORK & NEW ORLEANS--(BUSINESS WIRE)--Former Attorney General of Louisiana, Charles C. Foti, Jr., Esq., a partner at the law firm of Kahn Swick & Foti, LLC (“KSF”), announces that KSF has commenced an investigation into Lantheus Holdings, Inc. (NasdaqGM: LNTH). In August of 2025, contrary to the Company's prior optimistic outlook for the growth potential of its flagship product, Pylarify, the Company disclosed an 8% year-over-year decline in Pylarify revenue, as well as cuts to its full-.

In 1979, the Three Mile Island nuclear power plant suffered a partial nuclear meltdown.