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.

Rhea-AI Summary

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.

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

Argus Mar 18 session

-0.26% close to close 0.8x rel. volume Open Argus

Details

News Market Reaction – LNTH

On Mar 18, the first trading day after this news, LNTH closed 0.26% below the previous close.

Data tracked by StockTitan Argus for the Mar 18 session.

Key Figures

LNTH-2501 PDUFA date: June 29, 2026 Q4 2025 revenue: $406.8 million FY2025 revenue: $1.54 billion +5 more

LNTH-2501 PDUFA date

June 29, 2026

Revised PDUFA goal date after three-month extension

Q4 2025 revenue

$406.8 million

Fourth quarter 2025 reported revenue

FY2025 revenue

$1.54 billion

Full year 2025 reported revenue

FY2025 GAAP EPS

$3.41

Full year 2025 GAAP diluted EPS

FY2025 adj EPS

$6.08

Full year 2025 adjusted diluted EPS

FY2026 revenue guide

$1.4–1.45 billion

Company FY2026 revenue guidance range

FY2026 adj EPS guide

$5.00–5.25

Company FY2026 adjusted EPS guidance range

Share price

$78.50

Price before LNTH-2501 PDUFA extension announcement

Historical Context

5 past events · Latest: 2026-03-06

5 events

1. 2026-03-06

   FDA approval

   24h Move

   +10.3%

   FDA approval of PYLARIFY TruVu for broader PSMA PET imaging access.

2. 2026-03-02

   Regulatory tentative ok

   24h Move

   +1.9%

   FDA tentative approval of PNT2003 ANDA pending 30-month stay expiry.

3. 2026-02-26

   Earnings results

   24h Move

   -0.4%

   Q4 and FY2025 results plus FY2026 revenue and EPS guidance.

4. 2026-02-24

   Investor conferences

   24h Move

   +0.3%

   Announcement of CEO presentations at March 2026 investor conferences.

5. 2026-02-12

   Earnings call notice

   24h Move

   +2.1%

   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.

Key Terms

pdufa, new drug application, nda, pet, +4 more

8 terms

pdufa regulatory

"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 application regulatory

"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.

nda regulatory

"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.

pet medical

"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.

somatostatin receptor-positive medical

"Targeting Somatostatin Receptor-Positive (SSTR+) Neuroendocrine Tumors (NETs)"

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 medical

"Targeting Somatostatin Receptor-Positive (SSTR+) Neuroendocrine Tumors (NETs)"

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.

radiopharmaceutical medical

"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 68 medical

"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.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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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

Melissa Downs
Executive Director, External Communications
646-975-2533
media@lantheus.com

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

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.