Lantheus LNTH-2501 Review Period Extended by FDA
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Mar 18 2026
0mins
Should l Buy LNTH?
Source: seekingalpha
- 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.
Trade with 70% Backtested Accuracy
Stop guessing "Should I Buy LNTH?" and start using high-conviction signals backed by rigorous historical data.
Sign up today to access powerful investing tools and make smarter, data-driven decisions.
Analyst Views on LNTH
Wall Street analysts forecast LNTH stock price to fall
7 Analyst Rating
6 Buy
1 Hold
0 Sell
Strong Buy
Current: 91.000
Low
70.00
Averages
82.17
High
105.00
Current: 91.000
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 Holdings Reports Strong Q1 2026 Earnings Call Insights
- Strong Revenue Performance: Lantheus achieved $377.3 million in revenue for Q1 2026, reflecting year-over-year growth primarily driven by solid performances from PYLARIFY, NEURACEQ, and DEFINITY, indicating the company's ability to maintain stability in a competitive market.
- Product Transition Plan: The company plans to transition PYLARIFY directly to PYLARIFY TRUVU starting in Q4 2026, with significant revenue contributions expected in 2027, highlighting strategic decision-making in product innovation and market adaptability.
- Regulatory Milestone: The FDA approved PYLARIFY TRUVU on March 6, which is expected to enhance production capacity and patient coverage, further solidifying Lantheus's market position in the radiotherapeutic sector.
- Full-Year Performance Outlook: Despite a strong Q1, the CFO reiterated the full-year revenue guidance of $1.4 billion to $1.45 billion for 2026, reflecting the company's cautious stance amid competition and the CEO transition period.
See More
Lantheus Holdings Reports Strong Q1 Earnings Growth
- Significant Earnings Growth: Lantheus Holdings reported Q1 earnings of $118.42 million, translating to $1.80 per share, which marks a substantial increase from last year's $72.95 million and $1.02 per share, indicating enhanced competitiveness in the market.
- Adjusted Earnings Performance: Excluding special items, the company reported adjusted earnings of $95.80 million or $1.46 per share, showcasing a sustained improvement in core business profitability, which further solidifies investor confidence in the company's future growth.
- Slight Revenue Increase: The total revenue for the first quarter reached $377.33 million, up 1.2% from $372.76 million last year, demonstrating resilience and ongoing customer demand despite the modest growth rate in a stable market environment.
- Optimistic Market Outlook: With the improvement in earnings and stable market demand, Lantheus Holdings is poised to maintain its growth momentum in the future, attracting more investor interest in its long-term development potential.
See More
Lantheus Reports Strong Q1 2026 Results with $377.3M Revenue
- Revenue Growth: Lantheus achieved worldwide revenue of $377.3 million in Q1 2026, reflecting a 1.2% increase compared to the same period in 2025, indicating stable performance amidst competitive pressures.
- Profitability Improvement: The GAAP fully diluted earnings per share rose to $1.80, up 76.5% from $1.02 in Q1 2025, showcasing the company's success in cost control and operational efficiency.
- FDA Product Approvals: The company received FDA approval for PYLARIFY TruVuTM and plans a phased geographic launch starting in Q4 2026, which is expected to enhance market competitiveness and drive future revenue growth.
- Strategic Focus: Lantheus completed the divestiture of its SPECT business to concentrate on PET radiodiagnostics, aiming to accelerate growth in 2027 through optimized resource allocation and technology integration.
See More
Lantheus Holdings to Announce Q1 Earnings on May 7
- Earnings Announcement Schedule: Lantheus Holdings is set to announce its Q1 earnings on May 7 before market open, with a consensus EPS estimate of $1.23, reflecting a 19.6% year-over-year decline, indicating potential profitability challenges for the company.
- Revenue Expectations Decline: The consensus revenue estimate stands at $354.42 million, down 4.9% year-over-year, suggesting that the company may face challenges in market competition and will need to implement strategies to regain growth.
- Historical Performance Review: Over the past two years, Lantheus has beaten EPS estimates 50% of the time and revenue estimates 75% of the time, demonstrating a degree of capability to exceed expectations, but future sustainability remains to be seen.
- Estimation Revision Dynamics: In the last three months, EPS estimates have seen 4 upward revisions and 4 downward revisions, while revenue estimates have experienced 5 upward revisions and 2 downward revisions, indicating a divergence in analysts' outlook on the company's future performance.
See More
Lantheus to Host Q1 2026 Financial Results Call on May 7
- Conference Call Announcement: Lantheus Holdings will host a conference call on May 7, 2026, at 8:00 a.m. ET to discuss its Q1 2026 financial results and provide a business update, which is expected to deliver critical insights for investors.
- Registration Recommendation: The company encourages participants to register online 15 minutes in advance to avoid delays at the start of the call, demonstrating its commitment to enhancing the investor experience.
- Webcast Replay Availability: A replay of the call will be available approximately two hours after the conclusion of the webcast and will be archived on the same webpage for at least 30 days, allowing investors who could not attend live to access the information, thereby increasing transparency.
- Company Overview: Lantheus is a leading radiopharmaceutical-focused company with 70 years of experience, dedicated to enabling clinicians to find, fight, and follow diseases, ultimately improving patient outcomes through innovative scientific solutions.
See More
Lantheus Holdings Stock Surges Amid FDA Approvals
- Strong Stock Performance: Lantheus Holdings Inc (NASDAQ:LNTH) has seen its stock price rise approximately 23% year-to-date and over 46% in the past six months, reflecting strong market demand for its medical imaging solutions and heightened investor confidence.
- Product Portfolio Expansion: The company received FDA approval for its imaging agent PYLARIFY TruVu on March 6 and is awaiting FDA approval for its diagnostic imaging kit LNTH-2501, which has had its review extended by three months, with a decision expected by June 29, potentially enhancing its market competitiveness.
- Robust Financial Performance: In Q4 2025, Lantheus reported a 4.0% year-over-year revenue increase to $406.8 million, with a net income of $54.1 million compared to a net loss of $11.8 million in the same period last year, indicating significant improvement in profitability.
- Optimistic Market Outlook: Despite the extended review period for LNTH-2501, Citizens reiterated its Market Outperform rating and $85.00 price target for Lantheus, indicating confidence in the company's future growth potential, especially as the product is expected to be the only imaging kit with TPT reimbursement.
See More
Lantheus Holdings Reports Strong Q1 2026 Earnings Call Insights
- Strong Revenue Performance: Lantheus achieved $377.3 million in revenue for Q1 2026, reflecting year-over-year growth primarily driven by solid performances from PYLARIFY, NEURACEQ, and DEFINITY, indicating the company's ability to maintain stability in a competitive market.
- Product Transition Plan: The company plans to transition PYLARIFY directly to PYLARIFY TRUVU starting in Q4 2026, with significant revenue contributions expected in 2027, highlighting strategic decision-making in product innovation and market adaptability.
- Regulatory Milestone: The FDA approved PYLARIFY TRUVU on March 6, which is expected to enhance production capacity and patient coverage, further solidifying Lantheus's market position in the radiotherapeutic sector.
- Full-Year Performance Outlook: Despite a strong Q1, the CFO reiterated the full-year revenue guidance of $1.4 billion to $1.45 billion for 2026, reflecting the company's cautious stance amid competition and the CEO transition period.
See More
Lantheus Holdings Reports Strong Q1 Earnings Growth
- Significant Earnings Growth: Lantheus Holdings reported Q1 earnings of $118.42 million, translating to $1.80 per share, which marks a substantial increase from last year's $72.95 million and $1.02 per share, indicating enhanced competitiveness in the market.
- Adjusted Earnings Performance: Excluding special items, the company reported adjusted earnings of $95.80 million or $1.46 per share, showcasing a sustained improvement in core business profitability, which further solidifies investor confidence in the company's future growth.
- Slight Revenue Increase: The total revenue for the first quarter reached $377.33 million, up 1.2% from $372.76 million last year, demonstrating resilience and ongoing customer demand despite the modest growth rate in a stable market environment.
- Optimistic Market Outlook: With the improvement in earnings and stable market demand, Lantheus Holdings is poised to maintain its growth momentum in the future, attracting more investor interest in its long-term development potential.
See More
Lantheus Reports Strong Q1 2026 Results with $377.3M Revenue
- Revenue Growth: Lantheus achieved worldwide revenue of $377.3 million in Q1 2026, reflecting a 1.2% increase compared to the same period in 2025, indicating stable performance amidst competitive pressures.
- Profitability Improvement: The GAAP fully diluted earnings per share rose to $1.80, up 76.5% from $1.02 in Q1 2025, showcasing the company's success in cost control and operational efficiency.
- FDA Product Approvals: The company received FDA approval for PYLARIFY TruVuTM and plans a phased geographic launch starting in Q4 2026, which is expected to enhance market competitiveness and drive future revenue growth.
- Strategic Focus: Lantheus completed the divestiture of its SPECT business to concentrate on PET radiodiagnostics, aiming to accelerate growth in 2027 through optimized resource allocation and technology integration.
See More
Lantheus Holdings to Announce Q1 Earnings on May 7
- Earnings Announcement Schedule: Lantheus Holdings is set to announce its Q1 earnings on May 7 before market open, with a consensus EPS estimate of $1.23, reflecting a 19.6% year-over-year decline, indicating potential profitability challenges for the company.
- Revenue Expectations Decline: The consensus revenue estimate stands at $354.42 million, down 4.9% year-over-year, suggesting that the company may face challenges in market competition and will need to implement strategies to regain growth.
- Historical Performance Review: Over the past two years, Lantheus has beaten EPS estimates 50% of the time and revenue estimates 75% of the time, demonstrating a degree of capability to exceed expectations, but future sustainability remains to be seen.
- Estimation Revision Dynamics: In the last three months, EPS estimates have seen 4 upward revisions and 4 downward revisions, while revenue estimates have experienced 5 upward revisions and 2 downward revisions, indicating a divergence in analysts' outlook on the company's future performance.
See More
Lantheus to Host Q1 2026 Financial Results Call on May 7
- Conference Call Announcement: Lantheus Holdings will host a conference call on May 7, 2026, at 8:00 a.m. ET to discuss its Q1 2026 financial results and provide a business update, which is expected to deliver critical insights for investors.
- Registration Recommendation: The company encourages participants to register online 15 minutes in advance to avoid delays at the start of the call, demonstrating its commitment to enhancing the investor experience.
- Webcast Replay Availability: A replay of the call will be available approximately two hours after the conclusion of the webcast and will be archived on the same webpage for at least 30 days, allowing investors who could not attend live to access the information, thereby increasing transparency.
- Company Overview: Lantheus is a leading radiopharmaceutical-focused company with 70 years of experience, dedicated to enabling clinicians to find, fight, and follow diseases, ultimately improving patient outcomes through innovative scientific solutions.
See More
Lantheus Holdings Stock Surges Amid FDA Approvals
- Strong Stock Performance: Lantheus Holdings Inc (NASDAQ:LNTH) has seen its stock price rise approximately 23% year-to-date and over 46% in the past six months, reflecting strong market demand for its medical imaging solutions and heightened investor confidence.
- Product Portfolio Expansion: The company received FDA approval for its imaging agent PYLARIFY TruVu on March 6 and is awaiting FDA approval for its diagnostic imaging kit LNTH-2501, which has had its review extended by three months, with a decision expected by June 29, potentially enhancing its market competitiveness.
- Robust Financial Performance: In Q4 2025, Lantheus reported a 4.0% year-over-year revenue increase to $406.8 million, with a net income of $54.1 million compared to a net loss of $11.8 million in the same period last year, indicating significant improvement in profitability.
- Optimistic Market Outlook: Despite the extended review period for LNTH-2501, Citizens reiterated its Market Outperform rating and $85.00 price target for Lantheus, indicating confidence in the company's future growth potential, especially as the product is expected to be the only imaging kit with TPT reimbursement.
See More
