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Lantheus (LNTH) FDA Events

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FDA Events for Lantheus (LNTH)

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 177Lu-PNT2002, Lu-PNT2002, and PYLARIFY. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Lantheus' Drugs in FDA Review

177Lu-PNT2002 - FDA Regulatory Timeline and Events

177Lu-PNT2002 is a drug developed by Lantheus for the following indication: PSMA-targeted 177Lu-based radiopharmaceutical therapy that combines a PSMA-targeted ligand, PSMA-I&T, with the beta-emitting radioisotope no-carrier-added 177Lu. 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.

Lu-PNT2002 - FDA Regulatory Timeline and 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.

PYLARIFY (piflufolastat F 18) - FDA Regulatory Timeline and 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.

Lantheus FDA Events - Frequently Asked Questions

However, the company does has had drugs under review or in active clinical development.

In the past two years, Lantheus (LNTH) has reported FDA regulatory activity for the following drugs: PYLARIFY (piflufolastat F 18), Lu-PNT2002 and 177Lu-PNT2002.

The most recent FDA-related event for Lantheus occurred on February 5, 2025, involving PYLARIFY (piflufolastat F 18). The update was categorized as "Presentation," with the company reporting: "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."

Current therapies from Lantheus in review with the FDA target conditions such as:

  • Metastasis or recurrence of prostate cancer - PYLARIFY (piflufolastat F 18)
  • In PSMA-Positive Metastatic Castration-Resistant Prostate Cancer - Lu-PNT2002
  • PSMA-targeted 177Lu-based radiopharmaceutical therapy that combines a PSMA-targeted ligand, PSMA-I&T, with the beta-emitting radioisotope no-carrier-added 177Lu. - 177Lu-PNT2002

More FDA Event Resources from MarketBeat

  • NDA: New Drug Application
  • ANDA: Abbreviated New Drug Application
  • sNDA: Supplemental New Drug Application
  • BLA: Biologics License Application
  • sBLA: Supplemental Biologics License Application
  • FDA Approved: Approved by the FDA
  • EMA: European Medicines Agency
  • CE Mark: European Union Certification
  • NMPA: China National Medical Products Administration
  • MHLW: Japanese Ministry of Health
  • FDA Meeting: Consultation with FDA
  • Pre-IND: Pre-Investigational New Drug Meeting
  • Breakthrough Therapy: Special FDA designation for promising therapies
  • Fast Track: Accelerated FDA approval pathway
  • Orphan Drug: Designation for rare disease treatments
  • RPD: Rare Pediatric Disease Designation
  • RMAT: Regenerative Medicine Advanced Therapy
  • DSMB Review: Data Safety Monitoring Board Review
  • IDMC Review: Independent Data Monitoring Committee
  • MAA: MHRA Marketing Authorization Application
  • RTF: Refusal to File (Rejected Application)
  • 510(k): FDA Clearance for Medical Devices
  • Rolling Submission: Staggered regulatory review process

This page (NASDAQ:LNTH) was last updated on 7/11/2025 by MarketBeat.com Staff
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