Lantheus Announces Alzheimer’s Disease Radiodiagnostic MK-6240 Meets Co-Primary Endpoints in Two Pivotal Studies
“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
“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
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
Driven by rising prevalence, more treatment options, and expanded PET imaging guidelines, the
About Alzheimer’s Disease
Alzheimer’s disease is a degenerative neurological disorder that causes a decline in cognition and function. In the
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
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
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,
4Lohith TG, Bennacef I, Vandenberghe R, Vandenbulcke M,
Contacts:
Vice President, Investor Relations
978-671-8842
ir@lantheus.com
Executive Director, External Communications
646-975-2533
media@lantheus.com

Source: Lantheus Holdings, Inc.