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Nanobiotix (NBTX) FDA Events

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FDA Events for Nanobiotix (NBTX)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Nanobiotix (NBTX). Over the past two years, Nanobiotix has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as NBTXR3. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

NBTXR3 - FDA Regulatory Timeline and Events

NBTXR3 is a drug developed by Nanobiotix for the following indication: For the treatment of patients with stage 3, unresectable non-small cell lung cancer ("NSCLC"). 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.

Nanobiotix FDA Events - Frequently Asked Questions

As of now, Nanobiotix (NBTX) has not received any FDA approvals for its therapy in the last two years.

In the past two years, Nanobiotix (NBTX) has reported FDA regulatory activity for NBTXR3.

The most recent FDA-related event for Nanobiotix occurred on May 5, 2025, involving NBTXR3. The update was categorized as "Presentation," with the company reporting: "NANOBIOTIX announced the presentation of full results from the completed dose escalation and dose expansion phases of a Phase 1 study evaluating JNJ-1900 (NBTXR3) in patients with locally advanced or borderline resectable pancreatic cancer."

Currently, Nanobiotix has one therapy (NBTXR3) targeting the following condition: For the treatment of patients with stage 3, unresectable non-small cell lung cancer ("NSCLC")..

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:NBTX) was last updated on 7/10/2025 by MarketBeat.com Staff
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