Lantheus Announces FDA Acceptance of NDA for New Formulation for Market-Leading PSMA PET Imaging Agent
Lantheus Holdings (NASDAQ: LNTH) announced FDA acceptance of a New Drug Application (NDA) for a new formulation of its F 18 PSMA imaging agent. The FDA has set a PDUFA date of March 6, 2026 for the application filed by Lantheus' affiliate, Aphelion.
The new formulation is designed to optimize manufacturing and increase batch size by approximately 50%, building on the success of PYLARIFY, Lantheus' market-leading PSMA PET imaging agent. PYLARIFY has demonstrated an 86% median true-positive rate in detecting recurrent prostate cancer. The enhanced formulation aims to maintain the same efficacy while improving patient access and operational efficiency through increased radioactive concentration.
Lantheus Holdings (NASDAQ: LNTH) ha annunciato che la FDA ha accettato la New Drug Application (NDA) per una nuova formulazione del suo agente di imaging F 18 PSMA. La FDA ha fissato una data PDUFA per il 6 marzo 2026 per la domanda presentata dall'affiliata di Lantheus, Aphelion.
La nuova formulazione è stata progettata per ottimizzare la produzione e aumentare la dimensione del lotto di circa il 50%, basandosi sul successo di PYLARIFY, l'agente di imaging PSMA PET leader di mercato di Lantheus. PYLARIFY ha dimostrato un tasso mediano di veri positivi dell'86% nel rilevamento del cancro alla prostata recidivante. La formulazione migliorata mira a mantenere la stessa efficacia, migliorando al contempo l'accesso dei pazienti e l'efficienza operativa grazie a una maggiore concentrazione radioattiva.
Lantheus Holdings (NASDAQ: LNTH) anunció la aceptación por parte de la FDA de una Solicitud de Nuevo Medicamento (NDA) para una nueva formulación de su agente de imagen F 18 PSMA. La FDA ha establecido una fecha PDUFA para el 6 de marzo de 2026 para la solicitud presentada por la afiliada de Lantheus, Aphelion.
La nueva formulación está diseñada para optimizar la fabricación y aumentar el tamaño del lote en aproximadamente un 50%, basándose en el éxito de PYLARIFY, el agente de imagen PSMA PET líder en el mercado de Lantheus. PYLARIFY ha demostrado una tasa mediana de verdaderos positivos del 86% en la detección del cáncer de próstata recurrente. La formulación mejorada busca mantener la misma eficacia mientras mejora el acceso de los pacientes y la eficiencia operativa mediante una mayor concentración radiactiva.
Lantheus Holdings (NASDAQ: LNTH)가 F 18 PSMA 영상제의 새로운 제형에 대한 신약 신청서(NDA)를 FDA가 접수했다고 발표했습니다. FDA는 Lantheus의 자회사 Aphelion이 제출한 신청서에 대해 2026년 3월 6일을 PDUFA 기한으로 설정했습니다.
새로운 제형은 제조 최적화와 배치 크기를 약 50% 증가시키도록 설계되었으며, Lantheus의 시장 선도 PSMA PET 영상제인 PYLARIFY의 성공을 기반으로 합니다. PYLARIFY는 재발성 전립선암을 감지하는 데 있어 중앙값 86%의 진양성률을 입증했습니다. 개선된 제형은 동일한 효능을 유지하면서 방사능 농도 증가를 통해 환자 접근성과 운영 효율성을 향상시키는 것을 목표로 합니다.
Lantheus Holdings (NASDAQ : LNTH) a annoncé l'acceptation par la FDA d'une demande d'autorisation de mise sur le marché (NDA) pour une nouvelle formulation de son agent d'imagerie F 18 PSMA. La FDA a fixé une date PDUFA au 6 mars 2026 pour la demande déposée par l'affiliée de Lantheus, Aphelion.
La nouvelle formulation est conçue pour optimiser la fabrication et augmenter la taille des lots d'environ 50 %, s'appuyant sur le succès de PYLARIFY, l'agent d'imagerie PSMA PET leader sur le marché de Lantheus. PYLARIFY a démontré un taux médian de vrais positifs de 86 % dans la détection du cancer de la prostate récurrent. La formulation améliorée vise à maintenir la même efficacité tout en améliorant l'accès des patients et l'efficacité opérationnelle grâce à une concentration radioactive accrue.
Lantheus Holdings (NASDAQ: LNTH) gab bekannt, dass die FDA einen Antrag auf Zulassung eines neuen Medikaments (NDA) für eine neue Formulierung seines F 18 PSMA-Bildgebungsagents angenommen hat. Die FDA hat für den von Lantheus' Tochtergesellschaft Aphelion eingereichten Antrag ein PDUFA-Datum am 6. März 2026 festgelegt.
Die neue Formulierung wurde entwickelt, um die Herstellung zu optimieren und die Chargengröße um etwa 50 % zu erhöhen, basierend auf dem Erfolg von PYLARIFY, dem marktführenden PSMA-PET-Bildgebungsagenten von Lantheus. PYLARIFY hat eine mittlere Trefferquote von 86 % bei der Erkennung von rezidivierendem Prostatakrebs gezeigt. Die verbesserte Formulierung zielt darauf ab, die gleiche Wirksamkeit beizubehalten und gleichzeitig den Patientenzugang und die operative Effizienz durch eine erhöhte radioaktive Konzentration zu verbessern.
- Expected 50% increase in batch size production capacity
- Maintains high 86% median true-positive detection rate
- Potential for expanded geographic access through enhanced radioactive concentration
- Optimization of manufacturing process for improved operational efficiency
- Extended regulatory timeline with PDUFA date set for March 2026
- Pending FDA approval creates uncertainty for implementation
Insights
FDA acceptance of Lantheus' new PSMA imaging agent formulation signals potential 50% production increase, strengthening market position in prostate cancer diagnostics.
Lantheus has achieved a significant regulatory milestone with the FDA's acceptance of their New Drug Application (NDA) for an enhanced formulation of their flagship prostate cancer imaging product. The new formulation, which maintains the 86% median true-positive rate of their market-leading PYLARIFY agent, is designed to increase batch production capacity by approximately
This development represents a strategic manufacturing optimization rather than a novel diagnostic tool. By increasing the radioactive concentration of the agent, Lantheus aims to address several business-critical challenges simultaneously:
- Enhanced production efficiency with ~50% larger batch sizes
- Improved geographic reach into previously underserved markets
- Strengthened supply chain resilience for a time-sensitive radiopharmaceutical
- Expanded capacity to meet growing demand in prostate cancer diagnostics
The PDUFA date of March 6, 2026 establishes a clear regulatory timeline. If approved, this reformulation would reinforce Lantheus' dominant position in the PSMA PET imaging market without requiring providers to adapt to a fundamentally different product.
This manufacturing enhancement aligns with healthcare economics trends toward operational efficiency. By increasing the yield per production batch, Lantheus can potentially improve margins while maintaining pricing flexibility. The formulation optimization demonstrates how pharmaceutical companies can innovate beyond just new molecular entities to create shareholder value through production enhancements.
For Lantheus, whose identity is heavily tied to radiopharmaceuticals with inherently complex logistics and short half-lives, manufacturing improvements represent a particularly valuable competitive advantage that competitors cannot easily replicate.
Designed to expand PSMA PET imaging access for patients by increasing batch size by ~
PDUFA date set for March 6, 2026
BEDFORD, Mass., Aug. 06, 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 Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) for a new formulation of its F 18 PSMA imaging agent filed by its affiliate, Aphelion. The FDA has set an action date goal of March 6, 2026 under the Prescription Drug User Fee Act (PDUFA).
This NDA acceptance builds on the success of Lantheus’ market-leading PSMA PET imaging agent, PYLARIFY, which has demonstrated high diagnostic performance and meaningful impact on clinical decision making. If approved, we expect that this new formulation will offer an efficacy consistent with the market-leading PSMA PET agent, PYLARIFY, which has demonstrated an
“We are pleased the FDA accepted Aphelion’s NDA for the new piflufolastat F 18 formulation, which we expect will improve patient access due to a significant increase in the number of doses per batch,” said Brian Markison, CEO, Lantheus. “This formulation is a natural next step in our commitment to advancing PSMA imaging. There is a growing burden of prostate cancer in the U.S. and a clear need for accurate and early detection. Building on PYLARIFY’s proven performance and accuracy, Lantheus is well-positioned for continued leadership in prostate cancer imaging.”
This new formulation optimizes the manufacturing process and is expected to increase batch size by ~
“We have reached a key milestone and delivered on our commitment to advance prostate cancer imaging through sustainable innovation,” said Paul Blanchfield, President, Lantheus. “By enhancing the efficiency of production, we expect to improve patient access, streamline operations, and support the broader healthcare system’s ability to deliver timely diagnostic imaging.”
About Prostate Cancer
In the U.S., prostate cancer is the second most frequently diagnosed cancer and fifth-leading cause of cancer-related deaths among men globally. For 2025, estimates suggest nearly 315,000 new cases and more than 35,000 deaths.2 Projections indicate a significant increase in prostate cancer incidence, with annual cases expected to nearly double to 2.9 million by 2040.3 This is largely attributed to aging populations and increased life expectancy, particularly in low- and middle-income countries where healthcare access and early detection may be limited.
About PYLARIFY® (piflufolastat F 18) Injection
PYLARIFY® (piflufolastat F 18) injection (also known as 18F-DCFPyL or PyL) is a fluorinated small molecule PSMA-targeted PET imaging agent that enables visualization of lymph nodes, bone and soft tissue metastases to determine the presence or absence of recurrent and/or metastatic prostate cancer. For men with prostate cancer, PYLARIFY PET combines the accuracy of PET imaging, the precision of PSMA targeting and the clarity of an F 18 radioisotope for superior diagnostic performance. The recommended PYLARIFY dose is 333 MBq (9 mCi) with an acceptable range of 296 MBq to 370 MBq (8 mCi to 10 mCi), administered as a bolus intravenous injection.3-9
PYLARIFY has made a profound impact on the lives of patients battling prostate cancer. It is the number one ordered PSMA PET imaging agent in the U.S., and is a proven diagnostic backed by real-world experience, including in over 500,000 scans across 48 states, Puerto Rico and Washington, D.C.
PYLARIFY® (piflufolastat F 18) Injection
Indication
PYLARIFY® (piflufolastat F 18) Injection is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer:
- with suspected metastasis who are candidates for initial definitive therapy.
- with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level.
Important Safety Information
Contraindications
None.
Warnings and Precautions
Risk of Image Misinterpretation
Imaging interpretation errors can occur with PYLARIFY imaging. A negative image does not rule out the presence of prostate cancer and a positive image does not confirm the presence of prostate cancer. The performance of PYLARIFY for imaging of patients with biochemical evidence of recurrence of prostate cancer seems to be affected by serum PSA levels. The performance of PYLARIFY for imaging of metastatic pelvic lymph nodes prior to initial definitive therapy seems to be affected by risk factors such as Gleason score and tumor stage. PYLARIFY uptake is not specific for prostate cancer and may occur with other types of cancer as well as non-malignant processes and in normal tissues. Clinical correlation, which may include histopathological evaluation of the suspected prostate cancer site, is recommended.
Hypersensitivity Reactions
Monitor patients for hypersensitivity reactions, particularly patients with a history of allergy to other drugs and foods. Reactions may be delayed. Always have trained staff and resuscitation equipment available.
Radiation Risks
Diagnostic radiopharmaceuticals, including PYLARIFY, expose patients to radiation. Radiation exposure is associated with a dose-dependent increased risk of cancer. Ensure safe handling and preparation procedures to protect patients and health care workers from unintentional radiation exposure. Advise patients to hydrate before and after administration and to void frequently after administration.
Adverse Reactions
The most frequently reported adverse reactions were headaches, dysgeusia and fatigue, occurring at rate of ≤
Drug interactions
Androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, may result in changes in uptake of PYLARIFY in prostate cancer. The effect of these therapies on performance of PYLARIFY PET has not been established.
To report suspected adverse reactions for PYLARIFY, call 1-800-362-2668 or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Please read the accompanying full Prescribing Information also available at PYLARIFY.com.
Safe Harbor for Forward-Looking and Cautionary Statements
This press release contains “forward-looking statements” that are subject to risks and uncertainties. Forward-looking statements include, but are not limited to, statements relating to the potential FDA approval of the NDA for a new formulation of piflufolastat F18, the Company’s F-18 based PET imaging agent and statements regarding Lantheus’ expectations, hopes, beliefs, intentions or strategies regarding the future. Forward-looking statements may be identified by their use of terms such as “aim,” “designed,” “expect,” “expected,” “will” 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, including our ability to obtain FDA approval for our new formulation of PYLARIFY, to complete the technology transfer across our PET manufacturing facilities network for such new formulation, and to obtain adequate coding, coverage and payment, as well as the risk and uncertainties discussed in our filings with the Securities and Exchange Commission (including those described in the Risk Factors section in our Annual Reports on Form 10-K and our Quarterly Reports on Form 10-Q).
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 and Switzerland, Lantheus has been providing radiopharmaceutical solutions for nearly 70 years. For more information, visit www.lantheus.com.
1Morris MJ, et al; CONDOR Study Group. Diagnostic Performance of 18F-DCFPyL-PET/CT in Men with Biochemically Recurrent Prostate Cancer: Results from the CONDOR Phase III, Multicenter Study. Clin Cancer Res. 2021 Jul 1;27(13):3674-3682. doi: 10.1158/1078-0432.CCR-20-4573. Epub 2021 Feb 23. PMID: 33622706; PMCID: PMC8382991.
2American Cancer Society. Cancer Facts & Figures 2025. Atlanta: American Cancer Society; 2025. Available at https://www.cancer.org/research/cancer-facts-statistics/all-cancer-facts-figures/2025-cancer-facts-figures.html
3Harris E. Prostate Cancer Cases Might Rise to 3 Million Globally by 2040. JAMA. 2024;331(20):1698. doi:10.1001/jama.2024.6729
4PYLARIFY® [package insert]. North Billerica, MA: Progenics Pharmaceuticals, Inc., a Lantheus company.
5Data on file. Bedford, MA: Progenics Pharmaceuticals, Inc.; 2024.
6Mena E, Lindenberg ML, Turkbey IB, et al. 18F-DCFPyL PET/CT imaging in patients with biochemically recurrent prostate cancer after primary local therapy. J Nucl Med. 2020;61(6):881-889.
7Werner RA, Derlin T, Lapa C, et al. 18F-labeled, PSMA-targeted radiotracers: leveraging the advantages of radiofluorination for prostate cancer molecular imaging. Theranostics. 2020;10(1):1-16.
8Alipour R, Azad A, Hofman MS. Guiding management of therapy in prostate cancer: time to switch from conventional imaging to PSMA PET? Ther Adv Med Oncol. 2019;11:1-14.
9Petersen LJ, Zacho HD. PSMA PET for primary lymph node staging of intermediate and high-risk prostate cancer: an expedited systematic review. Cancer Imaging. 2020;20(1):10.
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
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