Lantheus Announces FDA Acceptance of New Drug Application for MK-6240, a PET Imaging Agent Targeting Tau in Alzheimer’s Disease
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) ha annunciato che la FDA ha accettato la sua Domanda di Nuovo Farmaco per MK-6240, un agente di imaging PET etichettato con F18 che mira ai grovigli neurofibrillari di tau nei pazienti valutati per la malattia di Alzheimer.
La NDA beneficia della designazione Fast Track precedente ed è supportata da due studi pivotal di fase 3 che hanno raggiunto gli endpoint co-primari per sensibilità e specificità. La FDA ha fissato una data obiettivo PDUFA per l'azione il 13 agosto 2026. La dirigenza ha detto che MK-6240 potrebbe integrare la PET con beta-amyloid e diagnosi basate sul sangue, se approvato.
Lantheus (NASDAQ: LNTH) anunció que la FDA aceptó su Solicitud de Nuevo Fármaco para MK-6240, un agente de imagenología PET etiquetado con F18 que apunta a los ovillos neurofibrilares de tau en pacientes evaluados por la enfermedad de Alzheimer.
La NDA se beneficia de la designación previa de Fast Track y está respaldada por dos ensayos pivotal de fase 3 que cumplieron los criterios co-primarios de sensibilidad y especificidad. La FDA estableció la fecha objetivo de acción PDUFA para el 13 de agosto de 2026. La dirección de la compañía afirmó que MK-6240 podría complementar la PET de beta-amiloide y diagnósticos basados en sangre si fuera aprobado.
Lantheus (NASDAQ: LNTH)는 FDA가 MK-6240에 대한 신약허가신청(NDA)을 접수했다고 발표했습니다. MK-6240은 알츠하이머 병으로 평가받는 환자의 tau 신경섬유 엉킴을 표적으로 하는 F18 표지 PET 영상 조영제입니다.
NDA는 이전의 Fast Track 지정의 혜택을 받고 있으며, 민감도와 특이도에 대한 동시 주요 종단점을 충족한 두 개의 결정적 Phase 3 연구로 뒷받침됩니다. FDA는 PDUFA target action date of August 13, 2026를 정했습니다. 회사 경영진은 승인을 받으면 MK-6240이 베타-아밀로이드 PET 및 혈액 기반 진단을 보완할 수 있다고 말했습니다.
Lantheus (NASDAQ: LNTH) a annoncé que la FDA a accepté sa demande de nouveau médicament pour MK-6240, un agent d’imagerie PET étiqueté F18 qui cible les enchevêtrements neurofibrillaires tau chez les patients évalués pour la maladie d’Alzheimer.
La NDA bénéficie de la désignation Fast Track préalable et est soutenue par deux essais pivot de phase 3 qui ont atteint des critères co-primaires de sensibilité et de spécificité. La FDA a fixé la date cible d’action PDUFA au 13 août 2026. La direction de l’entreprise a déclaré que MK-6240 pourrait compléter le PET bêta-amyloïde et les diagnostics basés sur le sang s’il est approuvé.
Lantheus (NASDAQ: LNTH) gab bekannt, dass die FDA seine Zulassungsanfrage (NDA) für MK-6240 akzeptiert hat, ein mit F18 markiertes PET-Bildgebungsagent, das Tau-Neurofibrillary-Tangles bei Patienten anspricht, die auf Alzheimer-Krankheit bewertet werden.
Die NDA profitiert von der vorherigen Fast Track-Zulassung und wird von zwei maßgeblichen Phase 3-Studien gestützt, die Ko-Primärendpunkte für Empfindlichkeit und Spezifität erfüllt haben. Die FDA setzte ein PDUFA-Zeitziel für die Entscheidung auf den 13. August 2026 fest. Die Unternehmensleitung sagte, MK-6240 könnte die Beta-Amyloid-PET und blutbasierte Diagnostik ergänzen, falls zugelassen.
Lantheus (NASDAQ: LNTH) أعلنت أن إدارة الغذاء والدواء الأمريكية اعتمدت طلب الدواء الجديد MK-6240، وهو عامل تصوير PET مُعلَّم بـ F18 يستهدف العقد العصبية Tau في المرضى الذين يُقيَّمون لاحتمالية وجود الزهايمر.
تستفيد NDA من التصميم السابق Fast Track ويدعمها تجربتان حاسمتان من المرحلة 3 حققتا نقاط النهاية المشتركة من حيث الحساسية والدقة. حددت FDA تاريخ الإجراء المستهدف PDUFA ليوم 13 أغسطس 2026. وقالت قيادة الشركة إن MK-6240 قد يُكمل PET للـ beta-amyloid والاختبارات المعتمدة على الدم إذا تمت الموافقة عليه.
Lantheus (NASDAQ: LNTH) 宣布 FDA 已接受其新药申请（NDA）用于 MK-6240，这是一种标记为 F18 的 PET 成像剂，靶向评估阿尔茨海默病患者的 tau 神经纤维缠结。
NDA 受益于先前的 Fast Track 指定，并由两项关键的 Phase 3 试验支持，达到了灵敏度和特异性的共同终点。FDA 将 PDUFA 目标行动日期设定为 2026 年 8 月 13 日。公司领导层表示，如果获批，MK-6240 可能与 β-淀粉样 PET 及基于血液的诊断共同发挥作用。
- FDA accepted NDA for MK-6240 with a PDUFA date of August 13, 2026
- Two pivotal Phase 3 trials met co-primary endpoints of sensitivity and specificity
- Fast Track designation from FDA for MK-6240
- None.
Insights
FDA accepted the NDA for MK-6240 with a
Lantheus gained formal FDA review for MK-6240, an F18 tau PET tracer, which advances its regulatory path from development into a potential marketed diagnostic. Acceptance and a set PDUFA date mean the agency found the NDA dossier complete enough to review, and the filing cites two pivotal Phase 3 trials that met co-primary endpoints of sensitivity and specificity for detecting tau neurofibrillary tangles.
The key dependencies to monitor are the FDA review questions, any advisory committee input, and the review of the Phase 3 datasets and manufacturing controls; deficiencies in those areas commonly drive delays or post-approval requirements. Watch the
PDUFA Date Set for August 13, 2026
BEDFORD, Mass., Oct. 28, 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 the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for MK-6240, the company’s investigational F18-labeled tau-targeted Positron Emission Tomography (PET) imaging agent for the detection of tau neurofibrillary tangle (NFT) pathology in patients with cognitive impairment being evaluated for Alzheimer’s disease. MK-6240 previously received Fast Track designation from the FDA for its potential to address an unmet medical need in Alzheimer’s disease diagnostics. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of August 13, 2026.
“We’re pleased the FDA has accepted our Fast Track application for MK-6240, highlighting the urgent need for innovative Alzheimer’s diagnostic tools and the potential of MK-6240 to meet that need by enabling direct visualization of tau pathology,” said Brian Markison, CEO, Lantheus. “With over 100 disease-modifying therapies in development, including about 30 targeting tau and 40 targeting beta amyloid, imaging plays a critical role in diagnosis and treatment selection. If approved, MK-6240 would complement beta-amyloid PET imaging and emerging blood-based diagnostics, helping guide treatment strategies for providers and patients.”
The NDA submission is supported by data from two pivotal Phase 3 clinical trials, which evaluated MK-6240’s performance in detecting tau pathology in early Alzheimer’s disease. These studies met their co-primary endpoints of sensitivity and specificity to detect tau NFTs.
About Alzheimer’s Disease and Dementia
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 65 and older with mild cognitive impairment and Alzheimer’s disease may grow to more than 20 million.1
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 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 previously received Fast Track designation and is currently being used in nearly 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.
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, Germany, Sweden, Switzerland and United Kingdom, 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 "designed,” “growing,” “potential,” “would,” 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 Risk Factors section in our most recently filed Annual Report on Form 10-K and Quarterly Reports on Form 10-Q).
1Alzheimer’s Association. 2024 Alzheimer’s Disease Facts and Figures. Alzheimer’s Dement 2024;20(5).
2Addressable market based on current management estimates, internal data, and current WAC / 340B pricing.
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
FAQ
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