Lantheus Announces FDA Grants PDUFA Date for LNTH-2501 (Ga 68 edotreotide), a PET Diagnostic Imaging Kit Targeting Somatostatin Receptor-Positive (SSTR+) Neuroendocrine Tumors (NETs)
Lantheus (NASDAQ: LNTH) announced the FDA has set a PDUFA target action date of March 29, 2026 for LNTH-2501 (Gallium-68 edotreotide), a PET diagnostic kit for localization of somatostatin receptor-positive (SSTR+) neuroendocrine tumors in adults and pediatric patients.
The submission was filed under the FDA 505(b)(2) pathway and builds on multiple published studies for Ga-68 edotreotide, positioning LNTH-2501 to expand Lantheus’ oncology diagnostic portfolio and broaden access to SSTR+ NET imaging.
Lantheus (NASDAQ: LNTH) ha annunciato che la FDA ha fissato una data obiettivo PDUFA per l'azione del 29 marzo 2026 per LNTH-2501 (Ga-68 edotreotide), un kit diagnostico PET per la localizzazione di tumori neuroendocrini positivi ai recettori della somatostatina (SSTR+) negli adulti e nei pazienti pediatrici.
La presentazione è stata presentata tramite la via FDA 505(b)(2) e si basa su molteplici studi pubblicati su Ga-68 edotreotide, posizionando LNTH-2501 per espandere il portafoglio diagnostico oncologico di Lantheus e ampliare l'accesso all'imaging dei NET SSTR+.
Lantheus (NASDAQ: LNTH) anunció que la FDA ha fijado una fecha objetivo de acción PDUFA del 29 de marzo de 2026 para LNTH-2501 (Ga-68 edotreotida), un kit diagnóstico PET para la localización de tumores neuroendocrinos positivos a receptores de somatostatina (SSTR+) en adultos y pacientes pediátricos.
La presentación se presentó bajo la vía de la FDA 505(b)(2) y se basa en múltiples estudios publicados para Ga-68 edotreotida, posicionando LNTH-2501 para ampliar la cartera diagnóstica oncológica de Lantheus y ampliar el acceso a la imagenología de NETS SSTR+.
Lantheus (NASDAQ: LNTH)는 FDA가 LNTH-2501( Gallium-68 edotreotide)에 대해 PDUFA 목표 조치일을 2026년 3월 29일로 설정했다고 발표했다. 이는 성상소마토스타틴 수용체 양성(SSTR+) 신경내분비 종양의 위치 확인을 위한 PET 진단 키트이다.
제출은 FDA 505(b)(2) 경로에 따라 접수되었으며 Ga-68 edotreotide에 대한 다수의 발표 연구를 바탕으로 LNTH-2501은 Lantheus의 암 진단 포트폴리오를 확장하고 SSTR+ NET 영상에 대한 접근성을 넓힐 예정이라고 설명했다.
Lantheus (NASDAQ: LNTH) a annoncé que la FDA a fixé une date cible d'action PDUFA au 29 mars 2026 pour LNTH-2501 (Gallium-68 edotreotide), un kit diagnostique PET pour la localisation des tumeurs neuroendocrines positives aux récepteurs de la somatostatine (SSTR+) chez les adultes et les patients pédiatriques.
La soumission a été déposée via la voie FDA 505(b)(2) et s'appuie sur de multiples études publiées sur le Ga-68 edotreotide, positionnant LNTH-2501 pour étendre le portefeuille diagnostique oncologique de Lantheus et élargir l'accès à l'imagerie NET SSTR+.
Lantheus (NASDAQ: LNTH) gab bekannt, dass die FDA eine Zieltermin für die PDUFA-Aktion auf den 29. März 2026 für LNTH-2501 (Gallium-68 edotreotide) festgelegt hat, ein PET-Diagnostikkit zur Lokalisierung von somatostatinrezeptor-positiven (SSTR+) Neuroendokrinen Tumoren bei Erwachsenen und pädiatrischen Patienten.
Die Einreichung wurde gemäß dem FDA 505(b)(2)-Weg eingereicht und baut auf mehreren veröffentlichten Studien zu Ga-68 edotreotide auf und positioniert LNTH-2501, um Lantheus’ onkologie-diagnostisches Portfolio zu erweitern und den Zugang zur SSTR+ NET-Bildgebung zu erleichtern.
Lantheus (NASDAQ: LNTH) أعلنت أن إدارة الغذاء والدواء الأمريكية قد حددت تاريخ هدف PDUFA للإجراء في 29 مارس 2026 لـ LNTH-2501 (Gallium-68 edotreotide)، وهو مجموعة فحص PET تشخيصية لتحديد المواقع للأورام العصبية الغدية المستقبلة للسوماتوستاتين الموجبة (SSTR+) لدى البالغين والمرضى الأطفال.
تم إرسال الطلب بموجب مسار FDA 505(b)(2) ويستند إلى عدة دراسات منشورة لـ Ga-68 edotreotide، مما يضع LNTH-2501 في مكانها لتوسيع محفظة تشخيص الأورام لدى Lantheus وتوسيع الوصول إلى تصوير NETs SSTR+.
- PDUFA date set for March 29, 2026
- Submitted via 505(b)(2) pathway leveraging published Ga-68 edotreotide evidence
- Expands oncology diagnostic portfolio with SSTR+ NET PET imaging kit
- FDA decision still pending; approval not guaranteed
PDUFA Date Set for March 29, 2026
BEDFORD, Mass., Oct. 30, 2025 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. (“Lantheus”) (NASDAQ: LNTH), the leading radiopharmaceutical-focused company committed to enabling clinicians to Find, Fight and Follow disease to deliver better patient outcomes, today announced that the U.S. Food and Drug Administration (FDA) has established a Prescription Drug User Fee Act (PDUFA) date for LNTH-2501 (Gallium-68 edotreotide). LNTH-2501 is a diagnostic kit for the preparation of Ga 68 edotreotide Injection, indicated for use with positron emission tomography (PET) imaging for localization of somatostatin receptor-positive (SSTR+) neuroendocrine tumors (NETs) in adult and pediatric patients.
The FDA has set a PDUFA target action date of March 29, 2026.
“The development of LNTH-2501 underscores our commitment to expanding access to high-quality diagnostic solutions in oncology,” said Brian Markison, CEO, Lantheus. “LNTH-2501 has the potential to provide clinicians a reliable and accessible option for identifying and managing somatostatin receptor-positive neuroendocrine tumors, ultimately supporting more informed treatment decisions and improved patient care.”
LNTH-2501 (Ga-68 edotreotide Injection) further expands Lantheus’ oncology diagnostic portfolio with a PET imaging kit for SSTR+ NETs. Submitted under the FDA’s 505(b)(2) pathway, the filing builds on an extensive evidence base for Ga-68 edotreotide, including multiple published studies. LNTH-2501 is designed to deliver high-quality, reliable and accessible SSTR+ NET imaging.
About Neuroendocrine Tumors (NETs)
Neuroendocrine tumors (NETs) are rare, often slow-growing cancers that can develop throughout the body.1 A subset known as gastroenteropancreatic NETs (GEP-NETs) affects the digestive system and pancreas and may be functional or non-functional depending on hormone activity. In the U.S., it is estimated that there are over 170,000 people living with NETs, with gastroenteropancreatic NETs (GEP-NETs), which are those NETs arising in the pancreas and digestive system, accounting for 55–
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. If approved, LNTH-2501 may complement Lantheus’ therapeutic candidate PNT2003 as part of a theranostic approach, advancing the company’s strategy to deliver integrated diagnostic and therapeutic solutions for patients with cancer.
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 nearly 70 years. For more information, visit www.lantheus.com.
Safe Harbor for Forward-Looking and Cautionary Statements
This press release contains “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. Forward-looking statements may be identified by their use of terms such as "designed,” “growing,” “potential,” “would,” and other similar terms. Such forward-looking statements are based upon current plans, estimates and expectations that are subject to risks and uncertainties that could cause actual results to materially differ from those described in the forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation that such plans, estimates and expectations will be achieved. 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: (i) a delay in obtaining, or failure to obtain, a positive regulatory outcome from the FDA for LNTH-2501; (ii) our ability to launch LNTH-2501 as a commercial product; (iii) the market receptivity to LNTH-2501 as a radiopharmaceutical diagnostic; (iv) the existence, availability and profile of competing products; (v) the potential of LNTH-2501 to complement Lantheus’ therapeutic candidate PNT2003 as part of a theranostic approach; and (ix) 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
_____________________________
REFERENCES:
1 Neuroendocrine Tumors. Cleveland Clinic. Published June 26, 2024. Accessed May 22, 2025. https://my.clevelandclinic.org/health/diseases/22006-neuroendocrine-tumors-net
2 Principles of Diagnosis and Management of Neuroendocrine Tumours. National Library of Medicine. Published March 13, 2017. Accessed May 22, 2025. https://pmc.ncbi.nlm.nih.gov/articles/PMC5359105/
3 P-136 Survey of Challenges in Access to Diagnostics and Treatment for Neuroendocrine Tumor Patients (SCAN): Early Diagnosis and Treatment Availability. Annals of Oncology. Published July 2020. Accessed May 22, 2025. https://www.annalsofoncology.org/article/S0923-7534(20)39517-X/fulltext
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