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BEDFORD, Mass. - The U.S. Food and Drug Administration has accepted Lantheus Holdings, Inc.’s (NASDAQ:LNTH) New Drug Application for MK-6240, an investigational PET imaging agent designed to detect tau pathology in patients being evaluated for Alzheimer’s disease, the company announced Tuesday. The company, currently valued at $3.95 billion, has maintained strong financial health with a "GREAT" rating according to InvestingPro metrics.
The FDA has set a target action date of August 13, 2026, for the application, which previously received Fast Track designation for its potential to address unmet needs in Alzheimer’s diagnostics.
MK-6240 is designed to target aggregated tau protein in the form of neurofibrillary tangles, a key hallmark of Alzheimer’s disease. The imaging agent would complement existing beta-amyloid PET imaging and emerging blood-based diagnostics if approved.
"We’re pleased the FDA has accepted our Fast Track application for MK-6240, highlighting the urgent need for innovative Alzheimer’s diagnostic tools," said Brian Markison, CEO of Lantheus, according to the press release. Despite the stock’s recent 45% decline over the past six months, InvestingPro analysis suggests the company is currently undervalued, with 8 additional exclusive ProTips available for subscribers.
The NDA submission is supported by data from two pivotal Phase 3 clinical trials that 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 neurofibrillary tangles.
Lantheus acquired MK-6240 in 2023, and the agent is currently being used in nearly 100 active clinical trials. According to the company, there are nearly 12 million people living with mild cognitive impairment or Alzheimer’s disease in the U.S., with projections suggesting this number could grow to more than 20 million by 2050.
The company estimates that the U.S. Alzheimer’s Disease radiodiagnostic market has the potential to reach over 400,000 scans and $1.5 billion by 2030. Lantheus appears well-positioned to capitalize on this opportunity, maintaining robust financials with a 63.75% gross profit margin and a healthy current ratio of 4.29. For detailed analysis and comprehensive insights, investors can access the full Pro Research Report, available exclusively on InvestingPro.
In other recent news, Lantheus Holdings has been at the center of several significant developments. The company recently announced an exclusive licensing agreement with GE HealthCare for its prostate cancer diagnostic imaging agent in Japan. This deal involves GE HealthCare taking on the development, manufacturing, and commercialization of the product, which could lead to regulatory submissions and a commercial launch in Japan. However, Lantheus has faced challenges with its Pylarify franchise, as noted by several analyst firms. Goldman Sachs downgraded the stock from Buy to Neutral, citing concerns about growth visibility and lowering its price target to $77.00. Similarly, Truist Securities downgraded the stock to Hold, with a new price target of $63.00, due to concerns about Pylarify’s performance. Leerink Partners also reduced its price target to $99.00, maintaining an Outperform rating, while highlighting competitive pressures affecting Pylarify. Additionally, Goldman Sachs adjusted its price target to $110.00, following Lantheus’s second-quarter revenue miss and reduced fiscal year 2025 guidance. These recent developments indicate a mix of strategic partnerships and financial challenges for Lantheus.
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