Lantheus Announces Three-Month Extension of PDUFA Date for LNTH-2501 (Ga 68 edotreotide), a PET Diagnostic Imaging Kit Targeting Somatostatin Receptor-Positive (SSTR+) Neuroendocrine Tumors (NETs)
Lantheus Announces Three-Month Extension of PDUFA Date for LNTH-2501 (Ga 68 edotreotide), a PET Diagnostic Imaging Kit Targeting Somatostatin Receptor-Positive (SSTR+) Neuroendocrine Tumors (NETs)
Lantheus (NASDAQ: LNTH) said the FDA extended the PDUFA date for LNTH-2501 (Gallium 68 edotreotide) by three months to June 29, 2026. The extension allows additional review of manufacturing information and is a standard delay not related to efficacy or safety.
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Positive
PDUFA date moved to June 29, 2026 (three‑month extension)
FDA requested additional manufacturing-related information for review
Company clarified extension is not related to efficacy or safety
Negative
Approval decision delayed by three months to June 29, 2026
News Market Reaction – LNTH
-0.26%
-0.26%Session close to close
In the Mar 18 session, LNTH declined 0.26%, reflecting a mild negative market reaction.
This announcement details a three-month extension of the LNTH-2501 PDUFA date to June 29, 2026, expl...
Analysis
This announcement details a three-month extension of the LNTH-2501 PDUFA date to June 29, 2026, explicitly described as unrelated to efficacy or safety and focused on manufacturing information review. It comes amid a busy regulatory period for Lantheus, including recent FDA approvals and tentative approvals. Investors may focus on how this timing adjustment interacts with the company’s broader pipeline, upcoming PDUFA dates, and previously issued FY2026 revenue and EPS guidance when assessing execution risk.
Scheduling of Q4 and FY2025 earnings conference call and webcast.
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Pattern Detected
Recent Lantheus news, especially FDA-related updates, has mostly seen price moves aligned with the positive tone, with one divergence on an earnings report.
Recent Company History
Over the last month, Lantheus reported strong Q4 and FY2025 results with revenue of $406.8 million for Q4 and $1.54 billion for 2025, alongside FY2026 guidance. The company also secured FDA approval for PYLARIFY TruVu and tentative approval for PNT2003, both followed by positive price reactions. Investor events and an earnings call announcement drew relatively small moves. Today’s three-month PDUFA extension for LNTH-2501 fits into a dense period of regulatory activity highlighted in recent disclosures.
Key Terms
pdufa, new drug application, nda, pet, +4 more
8 terms
pdufaregulatory
"The extension and revised target Prescription Drug User Free Act (PDUFA) goal date..."
PDUFA is the Prescription Drug User Fee Act, the U.S. law under which drug companies pay fees that fund the FDA's review of new medicines. In company news the term usually appears as the PDUFA date, the target deadline by which the FDA aims to decide on a drug application; that date tells investors when to expect the approval or rejection decision for the product.
new drug applicationregulatory
"has extended its review of the New Drug Application (NDA) for LNTH-2501..."
A new drug application is a formal request submitted to government regulators seeking approval to market a new medicine. It is like a detailed proposal that shows the drug has been tested for safety and effectiveness. For investors, receiving approval signals that the drug may soon become available for sale, potentially leading to revenue growth and impacting the company's value.
ndaregulatory
"has extended its review of the New Drug Application (NDA) for LNTH-2501..."
An NDA, or nondisclosure agreement, is a legal contract that keeps certain information private between parties. It’s like a promise not to share sensitive details, helping protect business ideas, strategies, or data from being leaked or used without permission. For investors, NDAs help ensure that confidential information remains secure, enabling trust and open communication during business discussions.
petmedical
"a PET Diagnostic Imaging Kit Targeting Somatostatin Receptor-Positive..."
Positron emission tomography (PET) is a medical imaging test that creates a live map of how organs and tissues are working by tracking a tiny, safe amount of radioactive tracer inside the body. For investors, PET matters because it’s often used in clinical trials and diagnosis to show whether a drug or treatment is affecting disease — think of it as a performance meter that can speed regulatory decisions, change market forecasts, and affect a product’s commercial value.
A tissue or tumor labeled “somatostatin receptor-positive” has cells that display somatostatin receptors on their surface, which act like locks that specific drugs or imaging agents can fit into like keys. That matters to investors because these receptors make the disease detectable by targeted scans and treatable with receptor-directed therapies, affecting how large the potential market is, how well treatments work, and how quickly regulatory or commercial milestones may be reached.
Neuroendocrine tumors are a type of abnormal growth that originates from cells responsible for releasing hormones into the bloodstream. These tumors can develop in various parts of the body and sometimes grow slowly or remain hidden for years. Their potential to affect hormone levels and spread makes them important for investors to monitor, especially as advancements in treatment may influence healthcare company performance.
radiopharmaceuticalmedical
"the leading radiopharmaceutical-focused company committed to enabling clinicians..."
A radiopharmaceutical is a special type of medicine that contains a small amount of radioactive material, used primarily for medical imaging or treatment. It can be thought of as a tiny, targeted signal that helps doctors see inside the body or deliver therapy directly to affected areas. For investors, understanding radiopharmaceuticals is important because they represent a growing field within healthcare, driven by advancements in diagnostics and personalized treatments.
gallium 68medical
"for LNTH-2501 (Gallium 68 edotreotide) by three months to June 29, 2026."
Gallium‑68 is a short‑lived radioactive isotope used as a tracer in medical PET scans to make tumors, infections or other biological processes visible on images; think of it as a tiny, glowing spotlight that doctors use to find hidden problems inside the body. It matters to investors because demand, supply, regulatory approval, and reimbursement for Gallium‑68 based diagnostic drugs and delivery systems can directly affect revenues and growth for makers of radiopharmaceuticals, imaging centers, and related suppliers.
BEDFORD, Mass., March 17, 2026 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. (“Lantheus” or “Company”) (NASDAQ: LNTH), the leading radiopharmaceutical-focused company committed to enabling clinicians to Find, Fight and Follow disease to deliver better patient outcomes, announced today that the U.S. Food and Drug Administration (FDA) has extended its review of the New Drug Application (NDA) for LNTH-2501 (Gallium 68 edotreotide) by three months to June 29, 2026.
The extension and revised target Prescription Drug User Free Act (PDUFA) goal date of June 29, 2026, 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.
About LNTH-2501 (Ga 68 edotreotide) LNTH-2501 (Kit for Preparation of Ga 68 edotreotide Injection), is currently under evaluation by the FDA as a radioactive diagnostic kit indicated for use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients. LNTH-2501 is supplied as a 2-vial kit to radiopharmacies which allows for direct preparation of Ga 68 edotreotide injection with the eluate of Gallium from an on-site generator at the radiopharmacy. LNTH-2501 is not currently approved by the FDA and is not yet available for sale in the United States.
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 the United Kingdom, Lantheus has been providing radiopharmaceutical solutions for 70 years. For more information, visit www.lantheus.com.
Safe Harbor for Forward-Looking and Cautionary Statements This press release may contain “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. 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 a delay in obtaining, or failure to obtain, a positive regulatory outcome from the FDA for LNTH-2501 and 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).
Contacts:
Lantheus Mark Kinarney Vice President, Investor Relations 978-671-8842 ir@lantheus.com
Why did the FDA extend the PDUFA date for LNTH-2501 (LNTH) to June 29, 2026?
The FDA extended the PDUFA date by three months to allow more time for manufacturing review. According to the company, the extension provides the agency additional time to consider manufacturing-related information submitted by Lantheus.
Does the PDUFA extension for LNTH-2501 signal safety or efficacy concerns for LNTH?
No, the extension is not related to safety or efficacy data for LNTH-2501. According to the company, the delay is a standard review extension tied to manufacturing information, not clinical results or safety findings.
How will the June 29, 2026 PDUFA extension affect LNTH commercialization timing?
The three-month extension shifts the regulatory decision timeline to June 29, 2026, delaying potential commercialization milestones. According to the company, the change reflects review time for manufacturing details rather than clinical issues.
What specific review area did the FDA request more information on for LNTH-2501 (LNTH)?
The FDA requested additional manufacturing-related information as part of its extended review for LNTH-2501. According to the company, the extra time is to assess those manufacturing submissions and is unrelated to efficacy or safety data.
When is the new target Prescription Drug User Fee Act (PDUFA) goal date for LNTH-2501 (LNTH)?
The revised PDUFA goal date is June 29, 2026, after a three-month extension. According to the company, this revised date reflects additional FDA review time focused on manufacturing information.
