Welcome to our dedicated page for Lantheus Holding news (Ticker: LNTH), a resource for investors and traders seeking the latest updates and insights on Lantheus Holding stock.
Lantheus Holdings, Inc. (NASDAQ: LNTH) is a radiopharmaceutical-focused company whose news flow centers on diagnostic imaging products, radiopharmaceutical pipeline progress and corporate developments. The company describes its purpose as enabling clinicians to "Find, Fight and Follow" disease, and its announcements frequently highlight advances in PET radiodiagnostics, oncology imaging agents and Alzheimer’s disease diagnostics.
News about Lantheus often covers regulatory milestones for its radiopharmaceutical pipeline. Recent releases include U.S. Food and Drug Administration (FDA) acceptance of a New Drug Application for a new formulation of its piflufolastat F 18 PSMA PET imaging agent, a PDUFA date for LNTH-2501 (Ga 68 edotreotide) for somatostatin receptor-positive neuroendocrine tumors, and FDA acceptance of an NDA for MK-6240, a tau-targeted PET imaging agent for Alzheimer’s disease. These updates provide insight into how the company is expanding its diagnostic portfolio in oncology and neurology.
Lantheus news also frequently addresses business development and portfolio shaping. The company has reported acquisitions of Evergreen Theragnostics and Life Molecular Imaging, adding assets such as OCTEVY and Neuraceq and expanding its capabilities across the radiopharmaceutical value chain. It has also announced the divestiture of its SPECT business to SHINE Technologies, along with licensing agreements such as an exclusive deal with GE HealthCare to develop, manufacture and commercialize PYLARIFY in Japan.
Investors and healthcare professionals following LNTH news can also expect quarterly earnings releases, stock repurchase program announcements, leadership transition updates and conference participation notices. Together, these items provide context on Lantheus’ financial performance, capital allocation, governance and strategic direction in the radiopharmaceutical and medical imaging space.
Lantheus (NASDAQ: LNTH) announced FDA approval of PYLARIFY TruVu (piflufolastat F 18), a new formulation of its PSMA PET imaging agent designed for larger batch production and broader patient access. The product, approved via the 505(b)(2) pathway relying on OSPREY and CONDOR data, is expected to launch in 4Q 2026 with a phased geographic rollout. More than 760,000 patients have received PSMA PET scans with PYLARIFY since May 2021. TruVu aims to improve stability at higher radioactive concentrations to enable larger batches and wider distribution.
Lantheus (NASDAQ: LNTH) received FDA tentative approval for its ANDA of Lutetium Lu 177 Dotatate (PNT2003), a radioequivalent to LUTATHERA®, on March 2, 2026. The tentative approval confirms the ANDA meets statutory requirements but full approval awaits expiration of a 30-month stay in June 2026.
The company licensed exclusive worldwide rights to PNT2003 from POINT Biopharma in December 2022; POINT was later acquired by Eli Lilly. Lantheus says it expects to seek final approval and make PNT2003 available to patients pending regulatory clearance.
Lantheus (NASDAQ: LNTH) reported Q4 2025 worldwide revenue of $406.8 million and full year 2025 revenue of $1.54 billion. GAAP diluted EPS was $0.82 in Q4 and $3.41 for FY2025; adjusted diluted EPS were $1.67 and $6.08, respectively.
The company completed acquisitions, repurchased shares, divested its legacy SPECT business, and issued FY2026 guidance: $1.4–1.45 billion revenue and $5.00–5.25 adjusted EPS.
Lantheus (NASDAQ: LNTH) announced that Mary Anne Heino, Executive Chairperson and CEO, will present at two investor conferences in March 2026: TD Cowen 46th Annual Health Care Conference on March 3, 2026 at 11:10 a.m. ET and Leerink Global Healthcare Conference on March 10, 2026 at 8:00 a.m. ET.
Live webcasts will be accessible via the Investors section of the company's website, with replays available for at least 30 days following each presentation.
Lantheus (NASDAQ: LNTH) will host a conference call and webcast at 8:00 a.m. ET on February 26, 2026 to discuss fourth quarter and full year 2025 financial and operating results. Participants should register online and are encouraged to register 15 minutes early to avoid delays.
A replay will be available approximately two hours after the webcast and archived on the events page for at least 30 days. Access registration at the company events calendar.
Lantheus (NASDAQ: LNTH) announced on January 2, 2026 that it has completed the sale of its SPECT business to SHINE Technologies. The divestiture transfers the SPECT diagnostic agents TechneLite, NEUROLITE, Xenon Xe-133, and Cardiolite, the portion of the North Billerica, Massachusetts campus that manufactures SPECT products, and SPECT-related Canadian operations to SHINE.
With the SPECT business closed, Lantheus will concentrate on its commercial PET radiodiagnostics and microbubbles and continue advancing its radiopharmaceutical pipeline. Financial, legal, and tax advisors to Lantheus on the transaction were disclosed.
Lantheus (NASDAQ: LNTH) will present new florbetaben F 18 data at Clinical Trials on Alzheimer’s Disease (CTAD) 2025, held December 1–4 in San Diego, CA. The company’s poster, titled "Florbetaben binding to amyloid plaques is unaffected by amyloid-targeting antibodies lecanemab and donanemab", is scheduled for Wednesday, December 3, 2025, during Session 06: Clinical Trials: Imaging (Poster P184).
The poster will be presented by Marianne Chapleau, Life Molecular Imaging. The session runs from 7:15 AM to 5:30 PM PT on that day.
Lantheus (NASDAQ: LNTH) reported Q3 2025 revenue $384.0M, GAAP EPS $0.41 and adjusted EPS $1.27, with free cash flow $94.7M. The company closed the acquisition of Life Molecular Imaging in July and repurchased $100M of common stock in Q3. Management announced the planned retirement of CEO effective Dec 31, 2025 and the Board is conducting a CEO search. FDA PDUFA target action dates were set for a new piflufolastat F 18 formulation (Mar 6, 2026), LNTH-2501 Ga 68 kit (Mar 29, 2026) and MK-6240 (Aug 13, 2026). Updated FY2025 guidance: $1.49B–$1.51B revenue and $5.50–$5.65 adjusted EPS.
Lantheus (NASDAQ: LNTH) announced a planned leadership transition: CEO Brian Markison will retire effective Dec 31, 2025 and will serve as strategic advisor through at least Mar 31, 2026. The Board has begun a CEO search. Chairperson Mary Anne Heino will become Executive Chairperson effective Nov 7, 2025 and will act as interim CEO after Markison’s retirement. President Paul Blanchfield is leaving the company; Heino and Markison will assume his responsibilities. Amanda Morgan returns from leave as Chief Commercial Officer reporting to Heino.
The release highlights completed acquisitions (Evergreen Theragnostics, Life Molecular Imaging, Meilleur Technologies) and multiple near-term potential FDA approvals, with management positioning for continued commercial execution.
Lantheus (NASDAQ: LNTH) announced the FDA has set a PDUFA target action date of March 29, 2026 for LNTH-2501 (Gallium-68 edotreotide), a PET diagnostic kit for localization of somatostatin receptor-positive (SSTR+) neuroendocrine tumors in adults and pediatric patients.
The submission was filed under the FDA 505(b)(2) pathway and builds on multiple published studies for Ga-68 edotreotide, positioning LNTH-2501 to expand Lantheus’ oncology diagnostic portfolio and broaden access to SSTR+ NET imaging.