Lantheus Holdings, Inc. 8K

Lantheus reported Q1 2026 financial results, announced multiple FDA approvals and regulatory milestones for its radiopharmaceutical portfolio, reaffirmed 2026 guidance, and detailed the strategic shift toward PET radiodiagnostics following the divestiture of its SPECT business.

Lantheus Holdings, Inc. filed a Form 8-K to furnish its first quarter 2026 financial results and business update, reporting modest revenue growth to $377.3 million, significantly higher GAAP EPS of $1.80 versus $1.02 a year earlier (though adjusted EPS declined), stronger cash and liquidity, and the impact of divesting its SPECT business. The company highlighted key regulatory milestones, including FDA approval of PYLARIFY TruVu (with a phased U.S. launch planned for Q4 2026), FDA tentative approval for Lutetium Lu 177 Dotatate (PNT2003) as a radioequivalent treatment for GEP-NETs, and a three‑month PDUFA extension to June 29, 2026 for LNTH‑2501 to allow additional review of manufacturing data. Lantheus reaffirmed its full-year 2026 revenue guidance of $1.4–$1.45 billion and adjusted fully diluted EPS guidance of $5.00–$5.25, and described its strategic focus on PET radiodiagnostics, preparation for conversion to PYLARIFY TruVu, expansion of its neurology imaging portfolio, and continued disciplined capital allocation following the sale of the legacy SPECT business.

Filing Facts

CIK

1521036

Ticker

-

Form

8K

Source Type

fda

Accession

0001193125-26-210369

Alert Tier

6