This section highlights FDA-related milestones and regulatory updates for drugs developed by Lantheus (LNTH).
Over the past two years, Lantheus has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
MK-6240, LNTH-2501, Piflufolastat, PYLARIFY, and Lu-PNT2002. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
MK-6240 FDA Regulatory Events
MK-6240 is a drug developed by Lantheus for the following indication: PET Imaging Agent Targeting Tau in Alzheimer's Disease.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- MK-6240
- Announced Date:
- August 14, 2026
- Indication:
- PET Imaging Agent Targeting Tau in Alzheimer's Disease
Announcement
Lantheus Holdings, Inc. announced U.S. Food and Drug Administration (FDA) approval of TAUKLARIFY™ (florquinitau F 18 injection), also referred to as MK-6240, a radiodiagnostic agent indicated for positron emission tomography (PET) of the brain in adults with cognitive impairment who are being evaluated for Alzheimer’s disease to identify patients with tau neurofibrillary tangle (NFT) pathology.
Read Announcement- Drug:
- MK-6240
- Announced Date:
- October 28, 2025
- Target Action Date:
- August 13, 2026
- Indication:
- PET Imaging Agent Targeting Tau in Alzheimer's Disease
Announcement
Lantheus Holdings, Inc. announced that The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of August 13, 2026.
AI Summary
Lantheus Holdings, Inc. announced that the U.S. Food and Drug Administration has accepted its New Drug Application for MK-6240, an investigational F18-labeled PET imaging agent designed to detect tau neurofibrillary tangles in patients with cognitive impairment. MK-6240 previously received Fast Track designation for its potential to fill an unmet need in Alzheimer’s disease diagnostics.
The FDA set a Prescription Drug User Fee Act (PDUFA) target action date of August 13, 2026 for MK-6240. This date marks when the agency aims to complete its review and decide whether to approve the agent for clinical use, helping to guide diagnosis and treatment strategies for Alzheimer’s disease.
The NDA submission is backed by two pivotal Phase 3 trials that met co-primary endpoints of sensitivity and specificity in detecting tau pathology. If approved, MK-6240 could complement existing beta-amyloid imaging and emerging blood tests, advancing early detection and patient management in Alzheimer’s care.
Read Announcement- Drug:
- MK-6240
- Announced Date:
- October 28, 2025
- Indication:
- PET Imaging Agent Targeting Tau in Alzheimer's Disease
Announcement
Lantheus Holdings, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for MK-6240, the company's investigational F18-labeled tau-targeted Positron Emission Tomography (PET) imaging agent for the detection of tau neurofibrillary tangle (NFT) pathology in patients with cognitive impairment being evaluated for Alzheimer's disease.
AI Summary
Lantheus Holdings announced that the U.S. Food and Drug Administration has accepted its New Drug Application for MK-6240, an investigational F18-labeled tau-targeted PET imaging agent. MK-6240 is designed to detect tau neurofibrillary tangles in patients with cognitive impairment being evaluated for Alzheimer’s disease.
The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of August 13, 2026, for its review. If approved, MK-6240 would allow physicians to visualize tau pathology directly, helping to confirm diagnosis and guide treatment decisions.
Submission of the NDA was supported by data from two pivotal Phase 3 trials that showed MK-6240 met co-primary endpoints for sensitivity and specificity in detecting tau tangles in early Alzheimer’s disease. By complementing beta-amyloid PET scans and blood-based tests, MK-6240 could play a key role in patient staging, therapy selection, and monitoring of emerging Alzheimer’s treatments.
Read Announcement
LNTH-2501 FDA Regulatory Timeline and Events
LNTH-2501 is a drug developed by Lantheus for the following indication: PET Diagnostic Imaging Kit Targeting Somatostatin Receptor-Positive (SSTR+) Neuroendocrine Tumors (NETs).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- LNTH-2501
- Announced Date:
- June 26, 2026
- Indication:
- PET Diagnostic Imaging Kit Targeting Somatostatin Receptor-Positive (SSTR+) Neuroendocrine Tumors (NETs)
Announcement
Lantheus Holdings, Inc. 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).
AI Summary
Lantheus Holdings said the FDA issued a Complete Response Letter for its New Drug Application for LNTH-2501, also known as gallium 68 edotreotide. The product is a PET imaging kit used to help detect somatostatin receptor-positive neuroendocrine tumors.
The FDA said it cannot approve the application by the June 29, 2026 action date because of unresolved manufacturing issues at a third-party facility that makes the drug product. These facility-related conditions must be fully resolved before approval can be granted.
Lantheus said the letter did not raise concerns about the data it submitted. It also did not identify any problems with the drug’s safety or effectiveness. The company will need to work with the third-party manufacturer and the FDA to address the inspection-related issues.
Read Announcement- Drug:
- LNTH-2501
- Announced Date:
- March 17, 2026
- Indication:
- PET Diagnostic Imaging Kit Targeting Somatostatin Receptor-Positive (SSTR+) Neuroendocrine Tumors (NETs)
Announcement
Lantheus Holdings, Inc. 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.
AI Summary
Lantheus Holdings, Inc. announced that the U.S. Food and Drug Administration has extended its review of the New Drug Application for LNTH-2501 (Gallium 68 edotreotide) by three months, moving the Prescription Drug User Fee Act (PDUFA) goal date to June 29, 2026. The company said the revised date gives regulators more time to complete their review.
The extension is a standard procedural delay to allow the FDA to consider additional manufacturing-related information that Lantheus submitted. Lantheus emphasized that this schedule change is not tied to safety or effectiveness issues with LNTH-2501. In short, the extra time is meant to let the agency fully evaluate production and quality details before reaching a decision.Read Announcement
- Drug:
- LNTH-2501
- Announced Date:
- October 30, 2025
- Target Action Date:
- March 29, 2026
- Indication:
- PET Diagnostic Imaging Kit Targeting Somatostatin Receptor-Positive (SSTR+) Neuroendocrine Tumors (NETs)
Announcement
Lantheus Holdings, Inc. 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).
AI Summary
Lantheus Holdings, Inc. announced that the U.S. Food and Drug Administration has set a Prescription Drug User Fee Act (PDUFA) date of March 29, 2026, for LNTH-2501 (Gallium-68 edotreotide). This diagnostic kit is designed for preparing Ga-68 edotreotide Injection, which works with PET imaging to locate somatostatin receptor-positive neuroendocrine tumors in adults and children.
Brian Markison, CEO of Lantheus, said the development of LNTH-2501 highlights the company’s dedication to expanding access to high-quality cancer diagnostics. He noted that this kit could give doctors a reliable tool for detecting and managing neuroendocrine tumors, helping guide treatment decisions and improving patient care.
Submitted under the FDA’s 505(b)(2) pathway, LNTH-2501 builds on existing evidence for Ga-68 edotreotide. If approved, it will expand Lantheus’s oncology imaging portfolio and support more accessible, accurate tumor localization.
Read Announcement
Piflufolastat F 18 (formerly 8F-DCFPyL) FDA Regulatory Events
Piflufolastat F 18 (formerly 8F-DCFPyL) is a drug developed by Lantheus for the following indication: Biochemically Recurrent Prostate Cancer (CONDOR).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Piflufolastat F 18 (formerly 8F-DCFPyL)
- Announced Date:
- March 6, 2026
- Indication:
- Biochemically Recurrent Prostate Cancer (CONDOR)
Announcement
Lantheus Holdings, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved PYLARIFY TruVu (piflufolastat F 18) injection, a new formulation of its F 18 prostate-specific membrane antigen (PSMA) imaging agent.
AI Summary
Lantheus announced that the U.S. Food and Drug Administration has approved PYLARIFY TruVu (piflufolastat F 18) injection, a new formulation of its F 18 PSMA PET imaging agent. PYLARIFY TruVu is indicated for PET imaging of PSMA-positive lesions in men with prostate cancer who have suspected metastasis and those with suspected recurrence based on elevated PSA.
The company says the new formulation combines the diagnostic performance of PYLARIFY with the potential for larger batch production and greater patient availability. PYLARIFY TruVu is expected to launch in the fourth quarter of 2026 and will roll out geographically in phases to allow a smooth customer transition.
PYLARIFY TruVu is a PSMA-targeted PET agent that helps visualize lymph node, bone and soft tissue metastases. Reported adverse reactions were uncommon (≤2%) and included headache, altered taste and fatigue; delayed hypersensitivity was rare. Radiation risks and safe handling recommendations apply.
Read Announcement- Drug:
- Piflufolastat F 18 (formerly 8F-DCFPyL)
- Announced Date:
- August 6, 2025
- Target Action Date:
- March 6, 2026
- Indication:
- Biochemically Recurrent Prostate Cancer (CONDOR)
Announcement
Lantheus Holdings, announced that The FDA has set an action date goal of March 6, 2026 under the Prescription Drug User Fee Act (PDUFA).
AI Summary
Lantheus Holdings, a leading radiopharmaceutical company, announced that the U.S. Food and Drug Administration has accepted a New Drug Application for its new F-18 PSMA imaging agent and set a Prescription Drug User Fee Act decision date of March 6, 2026. This new formula is filed by its affiliate, Aphelion.
This formulation aims to increase batch size by about 50%, boosting supply resilience and patient access. It maintains the same proven efficacy as PYLARIFY, which shows an 86% true-positive rate in studies of recurrent prostate cancer. Higher radioactive concentration also allows expansion into new geographic areas.
Brian Markison, CEO of Lantheus, said the updated agent marks a key step in improving prostate cancer imaging. Paul Blanchfield, president of Lantheus, added that optimizing production will streamline operations and help the healthcare system deliver fast, accurate diagnostic scans.
Read Announcement- Drug:
- Piflufolastat F 18 (formerly 8F-DCFPyL)
- Announced Date:
- August 6, 2025
- Indication:
- Biochemically Recurrent Prostate Cancer (CONDOR)
Announcement
Lantheus Holdings, 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.
AI Summary
Lantheus Holdings, through its affiliate Aphelion, announced that the U.S. Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) for a new formulation of its F 18 PSMA imaging agent. Under the Prescription Drug User Fee Act (PDUFA), the FDA’s review goal date is set for March 6, 2026.
This new formulation is designed to increase batch size by roughly 50%, which means more doses per production run. By optimizing the manufacturing process and raising radioactive concentration, Lantheus aims to enhance supply resilience and expand geographic access to PSMA PET imaging. The agent builds on the performance of PYLARIFY, its current market‐leading PSMA PET tracer that boasts an 86% median true‐positive rate in detecting recurrent prostate cancer.
Company leaders say the streamlined process will support timely diagnostic imaging, help clinicians detect prostate cancer earlier, and better meet growing patient needs across the U.S. If approved, the formulation may deliver consistent efficacy while serving significantly more patients.
Read Announcement
PYLARIFY (piflufolastat F 18) FDA Regulatory Events
PYLARIFY (piflufolastat F 18) is a drug developed by Lantheus for the following indication: Metastasis or recurrence of prostate cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- PYLARIFY (piflufolastat F 18)
- Announced Date:
- February 5, 2025
- Indication:
- Metastasis or recurrence of prostate cancer
Announcement
Lantheus Holdings, announced piflufolastat F 18 data will be presented at the 2025 American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium, taking place February 13-15, 2025, in San Francisco, CA.
AI Summary
Lantheus Holdings announced that data on its piflufolastat F 18 will be presented at the 2025 American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium. The event will be held in San Francisco, CA, from February 13-15, 2025. This data presentation focuses on the diagnostic performance of piflufolastat F 18, also known as 18F-DCFPyL or PYLARIFY, a PET imaging agent used to detect recurrent and metastatic prostate cancer.
The symposium will feature two sessions on February 13, 2025. One session, presented by Ida Sonni from the University of California, will detail the early detection of recurrent prostate cancer using 18F-DCFPyL PET/CT in patients with minimal PSA levels. In the other session, Neal Shore will share preliminary observations from the PYLARIFY registry, highlighting how conventional imaging and piflufolastat F 18 work together in diagnosing both new and recurrent cases of prostate cancer.
Read Announcement
Lu-PNT2002 FDA Regulatory Events
Lu-PNT2002 is a drug developed by Lantheus for the following indication: In PSMA-Positive Metastatic Castration-Resistant Prostate Cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Lu-PNT2002
- Announced Date:
- September 15, 2024
- Indication:
- In PSMA-Positive Metastatic Castration-Resistant Prostate Cancer
Announcement
Lantheus Holdings, Inc. presented additional clinical data from initial topline results of the SPLASH Phase 3 trial evaluating the efficacy of 177Lu-PNT2002, a prostate-specific membrane antigen (PSMA)-targeted radioligand therapy (RLT), administered at 6.8 GBq every 8 weeks for up to 4 cycles in patients with metastatic castration-resistant prostate cancer (mCRPC) following progression on androgen receptor pathway inhibitor (ARPI).
AI Summary
Lantheus Holdings, Inc. recently presented important clinical data from the SPLASH Phase 3 trial during the ESMO Congress 2024 in Barcelona. The study evaluated the use of 177Lu-PNT2002, a PSMA-targeted radioligand therapy (RLT), given at 6.8 GBq every 8 weeks for up to 4 cycles to patients with metastatic castration-resistant prostate cancer (mCRPC) who had progressed on androgen receptor pathway inhibitors (ARPI). The trial met its primary endpoint by significantly extending radiographic progression-free survival, with treated patients experiencing a median of 9.5 months compared to 6.0 months in the ARPI control arm. Additional benefits included a higher overall response rate and improved quality of life. These early results indicate that 177Lu-PNT2002 could offer a promising treatment option for mCRPC patients who have limited alternatives after ARPI therapy.
Read Announcement
