Lantheus Announces Alzheimer’s Disease Radiodiagnostic MK-6240 Meets Co-Primary Endpoints in Two Pivotal Studies
Lantheus Holdings announced positive results for its Alzheimer's disease radiodiagnostic MK-6240, which successfully met co-primary endpoints in two pivotal studies. The F18-labeled tau PET radiodiagnostic demonstrated strong sensitivity and specificity in detecting tau pathology, a key marker of Alzheimer's disease.
The company plans to submit a New Drug Application (NDA) to the FDA in Q3 2025. MK-6240 targets aggregated tau protein in neurofibrillary tangles and complements Lantheus' existing beta amyloid PET imaging agent, NAV-4694, currently in Phase 3 development.
Market projections indicate the U.S. Alzheimer's Disease radiodiagnostic market could reach over 400,000 scans and $1.5 billion by 2030, driven by increasing disease prevalence, expanded treatment options, and broader PET imaging guidelines. Over 100 therapies targeting beta amyloid or tau are currently in clinical development.
Lantheus Holdings ha annunciato risultati positivi per il suo radiodiagnostico MK-6240 per la malattia di Alzheimer, che ha raggiunto con successo gli endpoint co-primari in due studi fondamentali. Il radiodiagnostico tau PET marcato con F18 ha mostrato un'elevata sensibilità e specificità nel rilevare la patologia tau, un indicatore chiave della malattia di Alzheimer.
L'azienda prevede di presentare una Domanda di Nuovo Farmaco (NDA) alla FDA nel terzo trimestre del 2025. MK-6240 si focalizza sulla proteina tau aggregata nelle fibrille neurofibrillari e integra l'agente di imaging PET per beta amiloide NAV-4694 di Lantheus, attualmente in fase 3 di sviluppo.
Le previsioni di mercato indicano che il mercato statunitense dei radiodiagnostici per la malattia di Alzheimer potrebbe superare i 400.000 esami e raggiungere 1,5 miliardi di dollari entro il 2030, trainato dall'aumento della prevalenza della malattia, dall'espansione delle opzioni terapeutiche e da linee guida più ampie per l'imaging PET. Attualmente sono in sviluppo clinico oltre 100 terapie mirate a beta amiloide o tau.
Lantheus Holdings anunció resultados positivos para su radiodiagnóstico MK-6240 para la enfermedad de Alzheimer, que cumplió con éxito los puntos finales coprimarios en dos estudios clave. El radiodiagnóstico tau PET marcado con F18 demostró alta sensibilidad y especificidad en la detección de la patología tau, un marcador fundamental de la enfermedad de Alzheimer.
La compañía planea presentar una Solicitud de Nuevo Medicamento (NDA) a la FDA en el tercer trimestre de 2025. MK-6240 se dirige a la proteína tau agregada en ovillos neurofibrilares y complementa el agente de imagen PET para beta amiloide NAV-4694 de Lantheus, actualmente en desarrollo en fase 3.
Las proyecciones de mercado indican que el mercado estadounidense de radiodiagnósticos para la enfermedad de Alzheimer podría superar las 400,000 exploraciones y alcanzar los 1.5 mil millones de dólares para 2030, impulsado por el aumento de la prevalencia de la enfermedad, la ampliación de las opciones de tratamiento y unas directrices más amplias para la imagen PET. Actualmente, hay más de 100 terapias dirigidas a beta amiloide o tau en desarrollo clínico.
Lantheus Holdings는 알츠하이머병 방사선진단제 MK-6240에 대해 두 건의 주요 임상시험에서 공동 1차 평가변수를 성공적으로 충족하는 긍정적인 결과를 발표했습니다. F18 표지된 타우 PET 방사선진단제는 알츠하이머병의 핵심 지표인 타우 병리학을 감지하는 데 높은 민감도와 특이성을 보였습니다.
회사는 2025년 3분기에 FDA에 신약 신청서(NDA)를 제출할 계획입니다. MK-6240은 신경섬유 엉킴에 축적된 타우 단백질을 표적으로 하며, 현재 3상 개발 중인 Lantheus의 베타 아밀로이드 PET 영상제인 NAV-4694를 보완합니다.
시장 전망에 따르면 미국 알츠하이머병 방사선진단제 시장은 질병 유병률 증가, 치료 옵션 확대, PET 영상 가이드라인 확대에 힘입어 2030년까지 40만 건 이상의 스캔과 15억 달러 이상의 시장 규모에 이를 것으로 예상됩니다. 현재 베타 아밀로이드 또는 타우를 표적으로 하는 100개 이상의 치료제가 임상 개발 중입니다.
Lantheus Holdings a annoncé des résultats positifs pour son radiodiagnostic MK-6240 de la maladie d'Alzheimer, qui a atteint avec succès les critères d'évaluation co-primaires dans deux études pivots. Le radiodiagnostic tau PET marqué au F18 a démontré une forte sensibilité et spécificité dans la détection de la pathologie tau, un marqueur clé de la maladie d'Alzheimer.
L'entreprise prévoit de soumettre une dossier de demande de nouveau médicament (NDA) à la FDA au troisième trimestre 2025. MK-6240 cible la protéine tau agrégée dans les enchevêtrements neurofibrillaires et complète l'agent d'imagerie PET bêta-amyloïde NAV-4694 de Lantheus, actuellement en phase 3 de développement.
Les projections de marché indiquent que le marché américain des radiodiagnostics pour la maladie d'Alzheimer pourrait atteindre plus de 400 000 examens et 1,5 milliard de dollars d'ici 2030, porté par l'augmentation de la prévalence de la maladie, l'élargissement des options thérapeutiques et des directives plus larges pour l'imagerie PET. Plus de 100 thérapies ciblant la bêta-amyloïde ou la tau sont actuellement en développement clinique.
Lantheus Holdings gab positive Ergebnisse für seinen Radiodiagnostik MK-6240 bei Alzheimer-Erkrankung bekannt, der in zwei entscheidenden Studien die gemeinsamen primären Endpunkte erfolgreich erreichte. Der mit F18 markierte Tau-PET-Radiodiagnostik zeigte eine hohe Sensitivität und Spezifität bei der Erkennung der Tau-Pathologie, einem wichtigen Marker für Alzheimer.
Das Unternehmen plant, im dritten Quartal 2025 einen New Drug Application (NDA) bei der FDA einzureichen. MK-6240 zielt auf aggregiertes Tau-Protein in neurofibrillären Tangles ab und ergänzt den bereits existierenden Beta-Amyloid-PET-Imaging-Agenten NAV-4694 von Lantheus, der sich derzeit in Phase 3 der Entwicklung befindet.
Marktprognosen deuten darauf hin, dass der US-amerikanische Markt für Alzheimer-Radiodiagnostik bis 2030 über 400.000 Scans und 1,5 Milliarden US-Dollar erreichen könnte, angetrieben durch die steigende Krankheitsprävalenz, erweiterte Behandlungsoptionen und umfassendere PET-Bildgebungsrichtlinien. Über 100 Therapien, die Beta-Amyloid oder Tau anvisieren, befinden sich derzeit in klinischer Entwicklung.
- MK-6240 met co-primary endpoints in two pivotal studies, advancing towards potential FDA approval
- NDA submission planned for Q3 2025, indicating clear regulatory timeline
- U.S. Alzheimer's Disease radiodiagnostic market potential of 400,000 scans and $1.5B by 2030
- Company has two complementary Alzheimer's diagnostic agents (MK-6240 and NAV-4694) in development
- Strong market positioning as leader in radiopharmaceutical innovation
- Both key products (MK-6240 and NAV-4694) still in development phase, no current revenue generation
- Faces competition from over 100 therapies in clinical development targeting beta amyloid or tau
- Regulatory approval not guaranteed despite positive trial results
Insights
Lantheus' tau imaging agent MK-6240 achieves pivotal trial success, advancing toward NDA filing in critical Alzheimer's diagnostic market.
Lantheus' announcement that its F18-labeled tau PET radiodiagnostic MK-6240 met co-primary endpoints in two pivotal studies represents a significant clinical development milestone. The company has clearly stated its intention to file an NDA with the FDA in Q3 2025, establishing a concrete regulatory timeline.
The technical achievement here is noteworthy. MK-6240 targets aggregated tau protein in the form of neurofibrillary tangles (NFTs), one of the defining pathological hallmarks of Alzheimer's disease. This complements Lantheus' other radiodiagnostic candidate, NAV-4694, which targets beta-amyloid plaques - the other key pathological marker.
From a strategic portfolio perspective, Lantheus is building capabilities to visualize both major pathological hallmarks of Alzheimer's disease. The ability to detect tau pathology is particularly valuable as tau accumulation correlates more closely with cognitive decline than amyloid deposition alone.
The timing aligns with evolving clinical practices in Alzheimer's management. With the emergence of disease-modifying therapies targeting these pathologies, accurate biomarker identification becomes increasingly essential for patient selection and treatment monitoring. The press release notes approximately 100 therapies in clinical development targeting either beta amyloid or tau, highlighting the potential diagnostic demand.
Lantheus positions for $1.5B Alzheimer's diagnostic market by 2030 with dual-biomarker imaging strategy following MK-6240's pivotal success.
The successful pivotal studies for MK-6240 position Lantheus to capitalize on significant market opportunity in Alzheimer's diagnostics. The press release explicitly projects the U.S. Alzheimer's Disease radiodiagnostic market could reach over 400,000 scans and $1.5 billion by 2030, driven by three key factors: rising disease prevalence, expanding treatment options, and updated PET imaging guidelines.
This market projection reflects the growing importance of biomarker-confirmed diagnosis in the Alzheimer's care pathway. With the FDA's approval of disease-modifying therapies that target underlying pathology, confirming the presence of relevant pathological markers becomes essential for appropriate patient selection.
Lantheus is strategically developing two complementary radiodiagnostics that align with the two primary pathological targets in Alzheimer's disease: tau (MK-6240) and beta-amyloid (NAV-4694). This comprehensive approach addresses the clinical reality that both pathologies contribute to disease progression.
The market dynamics create a favorable environment for diagnostic innovation. The press release notes three specific market drivers: increasing prevalence, more treatment options requiring accurate diagnosis, and expanded PET imaging guidelines that support utilization.
With approximately 100 therapies in development targeting these pathways, the demand for accurate diagnostic tools is poised for substantial growth. The strategic value of Lantheus' dual biomarker approach is its alignment with this therapeutic pipeline, potentially positioning the company as a leader in the radiopharmaceutical innovation space for neurodegenerative conditions.
Company plans to file NDA in the third quarter of this year
BEDFORD, Mass., April 30, 2025 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. (“Lantheus”) (NASDAQ: LNTH), the leading radiopharmaceutical-focused company committed to enabling clinicians to Find, Fight and Follow disease to deliver better patient outcomes, today announced that its clinical-stage F18-labeled tau Positron Emission Tomography (PET) radiodiagnostic, MK-6240 (F18-florquinitau), successfully met its co-primary endpoints in two pivotal studies assessing its sensitivity and specificity. This achievement reinforces the potential of MK-6240 as a valuable diagnostic tool. The data from these two studies will support a New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA) expected to be filed in the third quarter of 2025.
“As a clinician, the ability to visualize tau pathology represents the opportunity for a seismic shift in how we diagnose and manage Alzheimer’s disease,” said Luca Passamonti, MD, PhD, Neuroscience Medical Director, Lantheus. “Tools like MK-6240 offer more than just clarity — they provide precision. By identifying tau accumulation early and accurately, we have the potential to improve diagnostic confidence, tailor patient care, and, through monitoring, ultimately change what we know about the trajectory of disease progression. This level of insight has long been missing in the field, and MK-6240, a next-generation imaging agent, has the potential to fill that critical gap.”
“The clinical results of MK-6240 underscore our commitment to providing cutting-edge imaging solutions for Alzheimer’s disease that align with the latest scientific advancements,” said Brian Markison, CEO, Lantheus. “With MK-6240 successfully meeting its primary endpoints in both pivotal studies, we are moving closer to delivering this innovative radiodiagnostic to potentially support precise diagnoses and improve disease management.”
MK-6240 is designed to target aggregated tau protein in the form of neurofibrillary tangles (NFTs), a key hallmark of several neurodegenerative diseases, including Alzheimer’s disease. The successful completion of these studies represents the next step in advancing MK-6240 as a potential tool to aid in the diagnosis, staging, and monitoring of Alzheimer’s disease.
The development of MK-6240 complements Lantheus’ ß amyloid PET imaging agent, NAV-4694 (F18-flutafuranol), which is currently in Phase 3 development and is actively utilized in both academic and industry-led investigational therapeutic trials for Alzheimer’s disease. Together, these imaging agents, if approved, will further position Lantheus as the leader in radiopharmaceutical innovation, supporting the evolving diagnostic landscape for neurodegenerative conditions.
Driven by rising prevalence, more treatment options, and expanded PET imaging guidelines, the U.S. Alzheimer’s Disease radiodiagnostic market has the potential to reach over 400,000 scans and
About Alzheimer’s Disease
Alzheimer’s disease is a degenerative neurological disorder that causes a decline in cognition and function. In the U.S., there are nearly 12 million people living with mild cognitive impairment or Alzheimer’s disease. As the population ages, it is likely that the prevalence of this disease will continue to rise and, by 2050, the number of people aged 65 and older with mild cognitive impairment and Alzheimer’s disease may grow to more than 20 million.2
About MK-6240
MK-6240 is designed to target aggregated tau protein in the form of neurofibrillary tangles (NFTs), a key hallmark of several neurodegenerative diseases, including Alzheimer’s disease. MK-6240 has demonstrated a high affinity for tau and limited off-target binding in both preclinical and clinical studies.3,4 Acquired by Lantheus in 2023, MK-6240 has received Fast Track designation and is currently being used in over 100 active clinical trials. We anticipate that MK-6240 will support earlier disease detection, patient staging, therapy selection, and monitoring, and may help enable tau to serve as a surrogate endpoint for treatment efficacy. Lantheus expects to file an NDA with the FDA in the third quarter of 2025.
About Lantheus
Lantheus is the leading radiopharmaceutical-focused company, delivering life-changing science to enable clinicians to Find, Fight and Follow disease to deliver better patient outcomes. Headquartered in Massachusetts with offices in New Jersey, Canada and Sweden, Lantheus has been providing radiopharmaceutical solutions for nearly 70 years. For more information, visit www.lantheus.com.
Safe Harbor for Forward-Looking and Cautionary Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, that are subject to risks and uncertainties and are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements may be identified by their use of terms such as "continue,” “expects,” “may,” “moving closer,” “plans,” “poised,” “position,”“potential,” “will,” and other similar terms. Such forward-looking statements are based upon current plans, estimates and expectations that are subject to risks and uncertainties that could cause actual results to materially differ from those described in the forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation that such plans, estimates and expectations will be achieved. Readers are cautioned not to place undue reliance on the forward-looking statements contained herein, which speak only as of the date hereof. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law. Risks and uncertainties that could cause our actual results to materially differ from those described in the forward-looking statements include: (i) a delay in obtaining, or failure to obtain, a positive regulatory outcome from the FDA for MK-6240; (ii) our ability to launch MK-6240 as a commercial product; (iii) the market receptivity to MK-6240 as a radiopharmaceutical diagnostic; (iv) the existence, availability and profile of competing products; (v) our ability to obtain and maintain adequate coding, coverage and payment for MK-6240; (vi) the safety and efficacy of MK-6240; (vii) the intellectual property protection of MK-6240; (viii) our ability to successfully develop and scale the manufacturing capabilities to support the launch of MK-6240; and (ix) the risks and uncertainties discussed in our filings with the Securities and Exchange Commission (including those described in the RiskFactors section in our most recently filed Annual Report on Form 10-K and Quarterly Reports on Form 10-Q).
1Addressable market based on current management estimates, internal data, and current WAC / 340B pricing.
2Alzheimer’s Association. 2024 Alzheimer’s Disease Facts and Figures. Alzheimer’s Dement 2024;20(5).
3Krishnadas N, Doré V, Robertson JS, Ward L, Fowler C, Masters CL, Bourgeat P, Fripp J, Villemagne VL, Rowe CC. Rates of regional tau accumulation in ageing and across the Alzheimer’s disease continuum: an AIBL 18F-MK-6240 PET study. EBioMedicine. 2023 Feb;88:104450. doi: 10.1016/j.ebiom.2023.104450. Epub 2023 Jan 27. PMID: 36709581; PMCID: PMC9900352.
4Lohith TG, Bennacef I, Vandenberghe R, Vandenbulcke M, Salinas CA, Declercq R, Reynders T, Telan-Choing NF, Riffel K, Celen S, Serdons K, Bormans G, Tsai K, Walji A, Hostetler ED, Evelhoch JL, Van Laere K, Forman M, Stoch A, Sur C, Struyk A. Brain imaging of Alzheimer dementia patients and elderly controls with 18F-MK-6240, a PET tracer targeting neurofibrillary tangles. J Nucl Med. 2019 Jan;60(1):107-114. doi: 10.2967/jnumed.118.208215. Epub 2018 Jun 7. PMID: 29880509.
Contacts:
Lantheus
Mark Kinarney
Vice President, Investor Relations
978-671-8842
ir@lantheus.com
Melissa Downs
Executive Director, External Communications
646-975-2533
media@lantheus.com
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