BEDFORD, Mass., June  26, 2026  (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. (&#34;Lantheus&#34; or &#34;Company&#34;) (NASDAQ:LNTH), the leading radiopharmaceutical-focused company committed to enabling clinicians to

LNTH

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

FDA CRL Delays LNTH-2501 NDA on Third-Party Manufacturing Issues

The U.S. ​Food and ‌Drug Administration declined ​to ​approve Lantheus Holdings' ⁠diagnostic imaging...

US FDA declines to approve Lantheus' tumor imaging kit

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  <section data-block="information">
    <h3>Information</h3>
    <p>BEDFORD, Mass., June  26, 2026  (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. (&amp;#34;Lantheus&amp;#34; or &amp;#34;Company&amp;#34;) (NASDAQ:LNTH), the leading radiopharmaceutical-focused company committed to enabling clinicians to</p>
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  <section data-block="ai-summary-paragraph">
    <h3>AI Summary</h3>
    <p>An FDA Complete Response Letter for LNTH-2501 cites unresolved third-party manufacturing conditions, causing a delay beyond the June 29, 2026 PDUFA date. The agency found no data or safety concerns. Lantheus will work with the partner and FDA to address facility issues and pursue a potential NDA resubmission, preserving LNTH-2501&#039;s clinical promise.</p>
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  <section data-block="ai-summary-bullets">
    <h3>Key Points</h3>
    <ul><li>FDA issues CRL for LNTH-2501 NDA due to third-party manufacturing. Data safety not questioned.</li><li>No data or safety concerns identified for LNTH-2501.</li><li>CEO stresses confidence and manufacturing partner remediation only.</li><li>LNTH-2501 is a two-vial Ga-68 edotreotide PET kit; not approved.</li></ul>
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  <section data-block="companies-mentioned">
    <h3>Companies Mentioned</h3>
    <ul><li><strong>Lantheus Holdings, Inc. (LNTH)</strong>: NDA setback for LNTH-2501; manufacturing issue could delay pipeline progress.</li><li><strong>U.S. Food and Drug Administration (FDA)</strong>: Issued the CRL; not due to data/safety concerns but third-party manufacturing.</li><li><strong>LNTH-2501 (Ga-68 edotreotide) kit (LNTH-2501)</strong>: NDA for PET imaging kit; not approved; two-vial kit; US sale not yet permitted.</li><li><strong>Unspecified third-party manufacturing partner (N/A)</strong>: Manufacturing facility conditions driving the approval delay; remediation key to timeline.</li></ul>
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  <section data-block="category">
    <h3>Industry News</h3>
    <p>Category: Industry News. The piece reports a regulatory setback affecting LNTH’s NDA timeline rather than new data; it highlights manufacturing validation as the critical path, which can meaningfully influence near-term valuation and sentiment in LNTH stock.</p>
  </section>

  <section data-block="market-moving">
    <h3>Market-Moving</h3>
    <ul><li>Regulatory setback from FDA CRL could delay LNTH-2501 NDA approval.</li><li>No safety/efficacy concerns identified, limiting downside to core business long-term.</li><li>PDUFA date missed; regulatory timeline remains uncertain.</li><li>Upside possible if manufacturing issues resolve promptly and FDA clears resubmission.</li></ul>
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  <section data-block="key-facts">
    <h3>Key Facts</h3>
    <ul><li>CRL issued June 26, 2026 for LNTH-2501 NDA.</li><li>PDUFA action date was June 29, 2026.</li><li>CRL cites unresolved third-party manufacturing-related conditions.</li><li>CRL not addressing safety or efficacy concerns.</li><li>LNTH-2501 is a Ga-68 edotreotide PET kit; two-vial.</li><li>Not approved or saleable in the United States yet.</li></ul>
  </section>

  <section data-block="trading-thesis">
    <h3>Trading Thesis</h3>
    <p>Near-term LNTH shares may weaken until manufacturing remediation advances and a resubmission timeline clarifies.</p>
  </section>
</section>


<link type="text/css" rel="stylesheet" href="https://www.globenewswire.com/styles/gnw_nitf.css"></link><p>BEDFORD, Mass., June  26, 2026  (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. ("Lantheus" or "Company") (NASDAQ:<a class="ticker" href="https://www.benzinga.com/quote/LNTH">LNTH</a>), 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). </p>  <p>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.</p>  <p>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.</p>  <p>"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."</p>  <p><strong>About LNTH-2501 (Ga 68 edotreotide)</strong><br></br>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.</p>  <p><strong>About Lantheus </strong><br></br>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 <a href="https://www.globenewswire.com/Tracker?data=YZkTOoSFzvRCgnIUyy5NkE8QpNcTDY1YRJJfGkhyZdU1MH6HX7JJ3xsP1eieJwN3trEtkTRAHURdpzxLEDZq0R8eZdB47iw-masMCvHZBA2Vlg88Jzp0z2J8B4cQ3c9SYdJxFGBNVe5rN8P-HwhSDznRbYndBCXAo_FxiI9OoFDwYyXxZmSave4loUCJdOc1lNjNeo67PPy85z0pegT7c42GU7ZkS0LwT8WDsi1F08mLZNQD60BExfrtEr0jW40aaIjlrLE939g7kr1-PvQzzqSs5BIlKMlXGwSiD3Eq3lStTGq1pHF5LzJopF4w4KTljYslgiag2aJUGezoflz5nXEIcWerL1KjIcoZa4cVHNRsy0kgSXiJWDBSJVgKV9dpEVr8oP2QvQlixlDxst2ZjFYAVquzYcHKdY9BqIj5iVx9UuZoMVWTw4DQR0QUQ5ph" rel="nofollow" target="_blank">www.lantheus.com</a>.  </p>  <p><strong>Safe Harbor for Forward-Looking and Cautionary Statements</strong><br></br>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).</p>  <p><strong>Contacts:</strong><br></br><br></br><strong>Lantheus</strong><br></br>Mark Kinarney<br></br>Vice President, Investor Relations<br></br>978-671-8842<br></br><a href="https://www.globenewswire.com/Tracker?data=xn086ylnxsS-8gGIY2MHd3CkhDGJ72DsLZ0e7LINDgDq7WOLEb-J2zvV1YoCHEwNb_qQQBPzRLxal1Cb3FZQNjHdjhT-_PghHwAFy_owF6A-xwFcIaFZ89Jz_XFR404pgAIRQDdEsyzPyVvlojOsUkksYqHy8N-uKiXrvvF32I23q8dSFwFChrSFJO9vGKEQn15sgT6_QpqkRkusZkHgf-EZe9_QgPtWDm5UcEfWEfY=" rel="nofollow" target="_blank">ir@lantheus.com</a></p>  <p>Melissa Downs<br></br>Executive Director, External Communications<br></br>646-975-2533<br></br><a href="https://www.globenewswire.com/Tracker?data=fo2UmttguZe__ycjvGJgxlJVMbxENdHS4Xim8JNTevrZxBCkYJSoDB9RjqSIrYe3TxLaWPUfW6AHC2FwxTqALuTj2antNaX-VaJogz21wJxb_9uq7XKDA1xrf6J4ArUgcTnREJyjpgSxwYOi4kHjlv4LGUlXiNqAwpwStHLxPi4D8c2nP___4XMwf8t6wIajQbUw0oB4BDTIRaGfqxunb8A-fnI5NhT2_DGzp9jFq_iF3-dlBo6rMNBKr-4iMnF5f9PGWIyAO6gd0XaEhP5Hiw==" rel="nofollow" target="_blank">media@lantheus.com</a></p> <img alt="" class="__GNW8366DE3E__IMG" src="https://www.globenewswire.com/newsroom/ti?nf=OTc1MzM5OSM3NjgwNTU0IzIwMDc2OTA="></img> <br></br><img alt="" src="https://ml.globenewswire.com/media/NDY2YmY5YzgtNGRiNC00NzdlLWFhODAtM2Q2ZWEzNThlMmViLTEwMTkyNjMtMjAyNi0wNi0yNi1lbg==/tiny/Lantheus-Holdings-Inc-.png" referrerpolicy="no-referrer-when-downgrade"></img><p><a href="https://www.globenewswire.com/NewsRoom/AttachmentNg/7ff76065-4799-4307-9b3d-033643bacc35"><img src="https://ml.globenewswire.com/media/7ff76065-4799-4307-9b3d-033643bacc35/small/lantheus-logo-png.png" border="0" width="150" height="34" alt="Primary Logo"></img></a></p>

An FDA Complete Response Letter for LNTH-2501 cites unresolved third-party manufacturing conditions, causing a delay beyond the June 29, 2026 PDUFA date. The agency found no data or safety concerns. Lantheus will work with the partner and FDA to address facility issues and pursue a potential NDA resubmission, preserving LNTH-2501's clinical promise.

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

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