Lantheus Receives Complete Response Letter from FDA for LNTH-2501 (Ga 68 edotreotide)

Rhea-AI Summary

Lantheus (NASDAQ: LNTH) received a Complete Response Letter (CRL) from the FDA for its LNTH-2501 (Ga 68 edotreotide) NDA, a PET imaging kit for SSTR+ neuroendocrine tumors. The FDA cannot approve by the June 29, 2026 PDUFA date due to unresolved third-party manufacturing facility inspection-related conditions, with no safety, efficacy, or data concerns cited.

Positive

• CRL cites no concerns about LNTH-2501 safety, efficacy, or submitted data
• Issues are limited to a third-party manufacturing facility, not the product itself
• Company reports active collaboration with its manufacturing partner and the FDA

Negative

• FDA issues CRL for LNTH-2501 NDA, halting approval progress
• NDA cannot be approved by June 29, 2026 PDUFA action date
• Unresolved inspection-related conditions at third-party manufacturing facility delay approval

News Market Reaction – LNTH

-0.20%

3 alerts

-0.20% Session close to close

-3.4% Trough Tracked

$7.15B Market Cap

0.2x Rel. Volume

In the Jun 29 session, LNTH declined 0.20%, reflecting a mild negative market reaction. Argus tracked a trough of -3.4% from its starting point during tracking. Our momentum scanner triggered 3 alerts that day, indicating moderate trading interest and price volatility.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement details an FDA CRL for LNTH-2501 driven by third-party manufacturing issues, not s...

Analysis

This announcement details an FDA CRL for LNTH-2501 driven by third-party manufacturing issues, not safety or efficacy. Prior news skewed positive but saw mixed reactions. Key risk is timing of facility remediation; investors will watch FDA interactions and partner progress.

Key Figures

PDUFA action date: June 29, 2026 Ga-68 isotope: 68

2 metrics

PDUFA action date June 29, 2026 Original FDA action date for LNTH-2501 NDA before CRL

Ga-68 isotope 68 Gallium 68 label in LNTH-2501 imaging agent

Historical Context

5 past events · Latest: Jun 03 (Positive)

Pattern 5 events

Date	Event	Sentiment	24h Move	Catalyst
Jun 03	Conference appearance	Positive	+4.1%	Participation in Goldman Sachs healthcare conference with webcast access.
Jun 02	Clinical recognition	Positive	-0.8%	SNMMI Image of the Year award for LNTH-2513 PET/CT thrombus imaging.
May 27	Conference appearance	Positive	-1.0%	Presentation at William Blair Growth Stock Conference with investor webcast.
May 21	Data presentations	Positive	-1.7%	New radiodiagnostic data presented at 2026 SNMMI Annual Meeting.
May 19	ASCO data	Positive	-0.6%	Radiopharmaceutical data at 2026 ASCO, including Phase 1/2 LNTH-2403 study.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Recent scientific and conference-related announcements have more often seen negative price reactions despite generally positive content.

Key Terms

complete response letter, new drug application, pet diagnostic imaging, somatostatin receptor-positive, +2 more

6 terms

complete response letter regulatory

"FDA has issued a Complete Response Letter (CRL) regarding its New Drug Application"

A complete response letter is an official communication from a drug or medical-device regulator, such as the U.S. Food and Drug Administration (FDA), telling a company that a marketing application cannot be approved in its current form and listing the specific deficiencies to be fixed. For investors it matters because it pauses or delays a product’s path to market—like a building inspector issuing a list of repairs before a certificate of occupancy—affecting revenue timing, costs and stock value.

new drug application regulatory

"Complete Response Letter (CRL) regarding its 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.

pet diagnostic imaging medical

"a PET diagnostic imaging kit targeting somatostatin receptor-positive (SSTR+)"

Pet diagnostic imaging is the use of pictures of an animal’s body—such as X‑rays, ultrasound, CT, MRI or nuclear scans—to find injuries, illnesses or abnormalities much like medical imaging for people. For investors it matters because these services and the equipment and software behind them create recurring revenue, higher-margin clinical services, and technology-driven growth opportunities, while also carrying capital, regulatory and adoption risks for veterinary businesses.

somatostatin receptor-positive medical

"PET diagnostic imaging kit targeting somatostatin receptor-positive (SSTR+) neuroendocrine tumors"

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.

pdufa regulatory

"cannot approve the NDA by the Prescription Drug User Fee Act (PDUFA) action 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.

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

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BEDFORD, Mass., June 26, 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 issued a Complete Response Letter (CRL) regarding its New Drug Application (NDA) for LNTH-2501 (Gallium 68 edotreotide), a PET diagnostic imaging kit targeting somatostatin receptor-positive (SSTR+) neuroendocrine tumors (NETs). 

The FDA stated that the agency cannot approve the NDA by the Prescription Drug User Fee Act (PDUFA) action date of June 29, 2026, due to unresolved third-party facility manufacturing-related conditions. The third-party facility is responsible for drug product manufacturing. Satisfactory resolution of the unresolved facility inspection-related conditions is required before the LNTH-2501 NDA may be approved.

The CRL did not identify any concerns regarding the data submitted by Lantheus in support of the application, nor did it identify any issues related to the safety or efficacy of LNTH-2501.

“We remain confident in LNTH-2501 and are committed to bringing this imaging agent to NETs patients and healthcare providers as soon as possible,” said Mary Anne Heino, Executive Chairperson and Chief Executive Officer, Lantheus. “The feedback received from the FDA relates solely to our third-party manufacturer, and not to the clinical performance of the product. We are working closely with our partner and the Agency to address these facility manufacturing-related conditions and advance the program.”

About LNTH-2501 (Ga 68 edotreotide)
LNTH-2501 (Kit for Preparation of Ga 68 edotreotide Injection), is an investigational 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 our ability to work with our third-party manufacturing partner to address the feedback outlined in the CRL in order 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

What did the FDA communicate to Lantheus (NASDAQ: LNTH) about LNTH-2501 on June 26, 2026?

The FDA issued a Complete Response Letter for Lantheus’ LNTH-2501 NDA. According to Lantheus, the agency cannot approve by the June 29, 2026 PDUFA date because of unresolved inspection-related conditions at a third-party manufacturing facility responsible for drug product manufacturing.

Why did the FDA issue a Complete Response Letter for Lantheus LNTH-2501 (Ga 68 edotreotide)?

The FDA issued the CRL due to unresolved third-party facility manufacturing-related conditions. According to Lantheus, these issues involve inspection-related conditions at the external drug product manufacturing site and must be satisfactorily resolved before the LNTH-2501 New Drug Application can be approved.

Did the FDA raise any safety or efficacy concerns about Lantheus LNTH-2501 in the June 2026 CRL?

The FDA did not identify safety or efficacy concerns for LNTH-2501. According to Lantheus, the CRL raised no issues with the clinical data supporting the application, and the feedback relates solely to manufacturing conditions at the third-party facility, not product performance.

How might the LNTH-2501 Complete Response Letter affect Lantheus (LNTH) approval timing?

The CRL means LNTH-2501 cannot be approved by the June 29, 2026 PDUFA date. According to Lantheus, approval now depends on satisfactorily resolving inspection-related manufacturing conditions at the third-party facility in coordination with its partner and the FDA.

What is LNTH-2501 (Ga 68 edotreotide) and which patients is Lantheus targeting?

LNTH-2501 is a PET diagnostic imaging kit targeting somatostatin receptor-positive neuroendocrine tumors. According to Lantheus, this agent is intended to help clinicians image SSTR+ NETs, supporting their mission to enable providers to Find, Fight and Follow disease for better patient outcomes.

What steps is Lantheus taking after the LNTH-2501 FDA Complete Response Letter?

Lantheus states it is working closely with its third-party manufacturing partner and the FDA. According to Lantheus, the focus is on addressing the facility manufacturing-related, inspection-linked conditions so the LNTH-2501 NDA can advance toward potential approval for neuroendocrine tumor imaging.