Lantheus Holding Stock Price, News & Analysis

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.

Lantheus (NASDAQ: LNTH) announced the FDA accepted its New Drug Application for MK-6240, an F18-labeled PET imaging agent targeting tau neurofibrillary tangles in patients evaluated for Alzheimer’s disease.

The NDA benefits from prior Fast Track designation and is supported by two pivotal Phase 3 trials that met co-primary endpoints for sensitivity and specificity. The FDA set a PDUFA target action date of August 13, 2026. Company leadership said MK-6240 could complement beta-amyloid PET and blood-based diagnostics if approved.

Lantheus (NASDAQ: LNTH) will host a Third Quarter 2025 earnings conference call and webcast on Thursday, November 6, 2025 at 8:00 a.m. ET to discuss financial results and provide a business update.

Participants should register online at https://investor.lantheus.com/news-events/calendar-of-events and are encouraged to register at least 15 minutes before the start to avoid delays. A replay will be posted about two hours after the webcast and archived on the same page for at least 30 days.

Lantheus Holdings (NASDAQ: LNTH) and GE HealthCare (NASDAQ: GEHC) have entered into an exclusive licensing agreement for GE HealthCare to develop, manufacture, and commercialize PYLARIFY® in Japan. The agreement focuses on prostate cancer diagnostics and companion diagnostic use.

PYLARIFY, a PET imaging agent for PSMA-positive lesions in prostate cancer patients, has already achieved success with over 500,000 scans across 48 states in the U.S. The deal includes regulatory dossiers transfer, manufacturing expertise, and technical support. GE HealthCare will leverage its network and R&D capabilities, particularly through its recently acquired Nihon Medi-Physics Co., Ltd.

Under the agreement terms, GE HealthCare will pay Lantheus an upfront license fee, development milestones, and tiered royalties based on Japanese market sales. The collaboration aims to address Japan's significant prostate cancer market, which ranks third globally in case numbers.

Lantheus Holdings (NASDAQ: LNTH), a leading radiopharmaceutical company, has announced its participation in the upcoming Morgan Stanley 23rd Annual Global Healthcare Conference. CEO Brian Markison will deliver a presentation on Tuesday, September 9, at 7:00 a.m. ET.

Investors and interested parties can access the live webcast through the Investors section of Lantheus.com. The presentation recording will remain available on the company's website for a minimum of 30 days following the live event.

Lantheus (NASDAQ: LNTH) reported Q2 2025 financial results with worldwide revenue of $378.0 million, down 4.1% year-over-year, and GAAP EPS of $1.12. The company completed two strategic acquisitions: Life Molecular Imaging, adding Neuraceq® for Alzheimer's diagnosis, and Evergreen Theragnostics, enhancing their radiopharmaceutical capabilities.

Key developments include FDA acceptance of a new NDA for piflufolastat F 18 PSMA PET imaging agent, FDA label expansion for Neuraceq, and a new $400 million stock repurchase program. PYLARIFY sales declined 8.3% to $250.6 million amid increased competition, while DEFINITY sales grew 7.5% to $83.9 million. The company revised its FY2025 guidance downward, now expecting revenue between $1.475-$1.51 billion and adjusted EPS of $5.50-$5.70.

Lantheus Holdings (NASDAQ: LNTH) announced FDA acceptance of a New Drug Application (NDA) for a new formulation of its F 18 PSMA imaging agent. The FDA has set a PDUFA date of March 6, 2026 for the application filed by Lantheus' affiliate, Aphelion.

The new formulation is designed to optimize manufacturing and increase batch size by approximately 50%, building on the success of PYLARIFY, Lantheus' market-leading PSMA PET imaging agent. PYLARIFY has demonstrated an 86% median true-positive rate in detecting recurrent prostate cancer. The enhanced formulation aims to maintain the same efficacy while improving patient access and operational efficiency through increased radioactive concentration.