Lantheus LNTH-2501 New Drug Application Review Extended to June 29
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Mar 17 2026
0mins
Should l Buy LNTH?
Lantheus announced that the FDA has extended its review of the new drug application for LNTH-2501 by three months to June 29. The extension and revised target Prescription Drug User Free Act, or PDUFA, goal date of June 29 will allow the FDA additional time to review and consider further manufacturing related information submitted by Lantheus. This standard review extension is not related to the efficacy or safety data of LNTH-2501.
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Analyst Views on LNTH
Wall Street analysts forecast LNTH stock price to rise
7 Analyst Rating
6 Buy
1 Hold
0 Sell
Strong Buy
Current: 75.700
Low
70.00
Averages
82.17
High
105.00
Current: 75.700
Low
70.00
Averages
82.17
High
105.00
About LNTH
Lantheus Holdings, Inc. is a radiopharmaceutical-focused company, dedicated to helping clinicians find, fight, and follow disease to deliver better patient outcomes. The Company's product categories include Radiopharmaceutical Oncology, Precision Diagnostics, and Strategic Partnerships and Others. The Company's Radiopharmaceutical Oncology products help healthcare professionals (HCPs) find, fight and follow cancer. The Company's Precision Diagnostic products assist HCPs to find and follow diseases. Its Strategic Partnerships include biomarkers and digital solutions in support of its partners’ therapeutic development, out-licensing agreements for non-core assets and optimization of its assets geographically. The Company's commercial products are used by cardiologists, internal medicine physicians, neurologists, nuclear medicine physicians, oncologists, radiologists, sonographers, technologists, and urologists working in a variety of clinical settings.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Lantheus LNTH-2501 Review Period Extended by FDA
- Review Period Extended: The FDA has announced a three-month extension for the review of Lantheus Holdings' (LNTH) LNTH-2501 radioactive diagnostic kit, with the new target action date set for June 29, 2026, indicating the regulator's emphasis on additional manufacturing data.
- Manufacturing Data Review: The extension is due to the FDA's need to review additional manufacturing-related data submitted by Lantheus, which does not pertain to the efficacy or safety of LNTH-2501, suggesting that the product's quality remains unquestioned.
- Market Impact: LNTH-2501 is designed for use with positron emission tomography (PET) to localize somatostatin receptor-positive neuroendocrine tumors (NETs), and this delay may affect Lantheus's competitive position in the PET imaging market.
- Financial Outlook: Lantheus forecasts revenue between $1.4 billion and $1.45 billion for 2026, and despite the review delay, the company is actively transforming its focus towards PET radiodiagnostics, demonstrating confidence in future growth.
See More
FDA Extends Review of LNTH-2501 by Three Months
- Review Extension: Lantheus Holdings, Inc. announced that the U.S. FDA has extended the review period for its LNTH-2501 by three months, with a new decision date set for June 29, allowing the agency additional time to review manufacturing-related information submitted by the company to ensure product quality.
- Focus on Manufacturing: The extension is not related to the efficacy or safety data of LNTH-2501, indicating that the FDA is primarily concerned with compliance in the production process, which could impact future market access and product promotion strategies.
- Diagnostic Tool Context: LNTH-2501 is a radioactive diagnostic kit for detecting somatostatin receptor positive neuroendocrine tumors in both adults and pediatric patients, and the growing market demand could present significant revenue potential for Lantheus.
- Market Reaction Outlook: While the review extension may introduce short-term uncertainty, the company's updates on Stocktwits indicate a commitment to transparency, which could help maintain investor confidence and mitigate market volatility.
See More
Lantheus Holdings Exceeds 2025 Financial Expectations
- Strong Financial Performance: Lantheus Holdings reported nearly $407 million in revenue for Q4 2025, a 4% increase year-over-year, and despite a slight drop in net income to $111 million, it surpassed the analyst consensus estimate of $1.17 per share, indicating robust market performance.
- Strategic Focus Shift: The company announced a strategic pivot towards innovative radiodiagnostics, prioritizing investments in PET radiodiagnostics while seeking value-maximizing alternatives for its radiotherapeutic assets, reflecting a keen insight into future market demands.
- Sales Dynamics: Although sales of its cancer imaging agent Pylarify fell nearly 10% year-over-year to over $240 million in Q4, the precision diagnostics product category surged 22%, generating over $143 million in revenue, showcasing the company's potential in emerging markets.
- Optimistic 2026 Outlook: Lantheus anticipates revenue between $1.4 billion and $1.45 billion for 2026, with adjusted per-share net profit expected to be between $5 and $5.25, both exceeding current analyst estimates, indicating strong confidence and growth potential for the company.
See More
U.S. Stock Futures Lower, Investors Eye Individual Stocks
- Market Dynamics: U.S. stock futures opened lower this morning on Monday, reflecting a cautious investor sentiment that may influence trading strategies for the day.
- Investor Focus: Despite the overall market decline, certain individual stocks may still attract investor attention, indicating a trend of market differentiation that could lead to capital flowing into specific sectors or companies.
- Expected Volatility: Market participants anticipate greater volatility in the stock market as economic data releases and corporate earnings reports approach, which could impact investor decision-making.
- Data Source: This market analysis is provided by Benzinga, highlighting the importance of real-time tracking and analysis of market dynamics to assist investors in making more informed investment choices.
See More
Lantheus Receives FDA Approval for New Imaging Agent
- FDA Approval: Lantheus Holdings Inc. announced that its new F 18 prostate-specific membrane antigen imaging agent, PYLARIFY TruVu, has received approval from the U.S. Food and Drug Administration (FDA), marking a significant advancement in prostate cancer imaging.
- Defined Indication: PYLARIFY TruVu is indicated for positron emission tomography (PET) imaging in prostate cancer patients, particularly for those with suspected metastasis, which is expected to provide more accurate diagnostic tools for patients.
- Market Launch Plan: The product is expected to be commercially available in the fourth quarter of 2026 and will be introduced on a rolling geographic basis, allowing customers to transition to the new formulation with minimal disruption, thereby enhancing market competitiveness.
- Market Reaction: Although Lantheus's stock fell by 4.91% to $72.56 during regular trading, it showed a slight recovery in after-hours trading, indicating potential market confidence in the new product, which may influence future stock performance.
See More
Lantheus Holdings' PYLARIFY TruVu Injection Receives FDA Approval
- Stock Price Surge: Shares of Lantheus Holdings, Inc. (LNTH) rose 5% in after-hours trading on Friday, reflecting positive market sentiment towards the company's new product and indicating investor confidence in its future growth potential.
- FDA Approval: The company announced that its PYLARIFY TruVu injection has received approval from the U.S. Food and Drug Administration (FDA), marking a significant milestone for the product's application in imaging for prostate cancer patients, which is expected to enhance the company's competitiveness in the medical imaging market.
- Market Launch Timeline: The injection is expected to be commercially available in the fourth quarter of 2026, suggesting that the company will realize new revenue streams in the coming years, further driving its financial performance and market share growth.
- Strategic Implications: This approval not only strengthens Lantheus's product portfolio in the prostate cancer treatment space but may also attract more investor attention, enhancing the company's overall image and market position within the biopharmaceutical industry.
See More
Lantheus LNTH-2501 Review Period Extended by FDA
- Review Period Extended: The FDA has announced a three-month extension for the review of Lantheus Holdings' (LNTH) LNTH-2501 radioactive diagnostic kit, with the new target action date set for June 29, 2026, indicating the regulator's emphasis on additional manufacturing data.
- Manufacturing Data Review: The extension is due to the FDA's need to review additional manufacturing-related data submitted by Lantheus, which does not pertain to the efficacy or safety of LNTH-2501, suggesting that the product's quality remains unquestioned.
- Market Impact: LNTH-2501 is designed for use with positron emission tomography (PET) to localize somatostatin receptor-positive neuroendocrine tumors (NETs), and this delay may affect Lantheus's competitive position in the PET imaging market.
- Financial Outlook: Lantheus forecasts revenue between $1.4 billion and $1.45 billion for 2026, and despite the review delay, the company is actively transforming its focus towards PET radiodiagnostics, demonstrating confidence in future growth.
See More
FDA Extends Review of LNTH-2501 by Three Months
- Review Extension: Lantheus Holdings, Inc. announced that the U.S. FDA has extended the review period for its LNTH-2501 by three months, with a new decision date set for June 29, allowing the agency additional time to review manufacturing-related information submitted by the company to ensure product quality.
- Focus on Manufacturing: The extension is not related to the efficacy or safety data of LNTH-2501, indicating that the FDA is primarily concerned with compliance in the production process, which could impact future market access and product promotion strategies.
- Diagnostic Tool Context: LNTH-2501 is a radioactive diagnostic kit for detecting somatostatin receptor positive neuroendocrine tumors in both adults and pediatric patients, and the growing market demand could present significant revenue potential for Lantheus.
- Market Reaction Outlook: While the review extension may introduce short-term uncertainty, the company's updates on Stocktwits indicate a commitment to transparency, which could help maintain investor confidence and mitigate market volatility.
See More
Lantheus Holdings Exceeds 2025 Financial Expectations
- Strong Financial Performance: Lantheus Holdings reported nearly $407 million in revenue for Q4 2025, a 4% increase year-over-year, and despite a slight drop in net income to $111 million, it surpassed the analyst consensus estimate of $1.17 per share, indicating robust market performance.
- Strategic Focus Shift: The company announced a strategic pivot towards innovative radiodiagnostics, prioritizing investments in PET radiodiagnostics while seeking value-maximizing alternatives for its radiotherapeutic assets, reflecting a keen insight into future market demands.
- Sales Dynamics: Although sales of its cancer imaging agent Pylarify fell nearly 10% year-over-year to over $240 million in Q4, the precision diagnostics product category surged 22%, generating over $143 million in revenue, showcasing the company's potential in emerging markets.
- Optimistic 2026 Outlook: Lantheus anticipates revenue between $1.4 billion and $1.45 billion for 2026, with adjusted per-share net profit expected to be between $5 and $5.25, both exceeding current analyst estimates, indicating strong confidence and growth potential for the company.
See More
U.S. Stock Futures Lower, Investors Eye Individual Stocks
- Market Dynamics: U.S. stock futures opened lower this morning on Monday, reflecting a cautious investor sentiment that may influence trading strategies for the day.
- Investor Focus: Despite the overall market decline, certain individual stocks may still attract investor attention, indicating a trend of market differentiation that could lead to capital flowing into specific sectors or companies.
- Expected Volatility: Market participants anticipate greater volatility in the stock market as economic data releases and corporate earnings reports approach, which could impact investor decision-making.
- Data Source: This market analysis is provided by Benzinga, highlighting the importance of real-time tracking and analysis of market dynamics to assist investors in making more informed investment choices.
See More
Lantheus Receives FDA Approval for New Imaging Agent
- FDA Approval: Lantheus Holdings Inc. announced that its new F 18 prostate-specific membrane antigen imaging agent, PYLARIFY TruVu, has received approval from the U.S. Food and Drug Administration (FDA), marking a significant advancement in prostate cancer imaging.
- Defined Indication: PYLARIFY TruVu is indicated for positron emission tomography (PET) imaging in prostate cancer patients, particularly for those with suspected metastasis, which is expected to provide more accurate diagnostic tools for patients.
- Market Launch Plan: The product is expected to be commercially available in the fourth quarter of 2026 and will be introduced on a rolling geographic basis, allowing customers to transition to the new formulation with minimal disruption, thereby enhancing market competitiveness.
- Market Reaction: Although Lantheus's stock fell by 4.91% to $72.56 during regular trading, it showed a slight recovery in after-hours trading, indicating potential market confidence in the new product, which may influence future stock performance.
See More
Lantheus Holdings' PYLARIFY TruVu Injection Receives FDA Approval
- Stock Price Surge: Shares of Lantheus Holdings, Inc. (LNTH) rose 5% in after-hours trading on Friday, reflecting positive market sentiment towards the company's new product and indicating investor confidence in its future growth potential.
- FDA Approval: The company announced that its PYLARIFY TruVu injection has received approval from the U.S. Food and Drug Administration (FDA), marking a significant milestone for the product's application in imaging for prostate cancer patients, which is expected to enhance the company's competitiveness in the medical imaging market.
- Market Launch Timeline: The injection is expected to be commercially available in the fourth quarter of 2026, suggesting that the company will realize new revenue streams in the coming years, further driving its financial performance and market share growth.
- Strategic Implications: This approval not only strengthens Lantheus's product portfolio in the prostate cancer treatment space but may also attract more investor attention, enhancing the company's overall image and market position within the biopharmaceutical industry.
See More
