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Nanobiotix (NBTX) FDA Approvals

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Nanobiotix's Drugs in the FDA Approval Process

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 JNJ-1900 and NBTXR3. 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.

JNJ-1900 FDA Regulatory Events

JNJ-1900 is a drug developed by Nanobiotix for the following indication: for patients with 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.

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

In the past two years, Nanobiotix (NBTX) has not received FDA approval for any therapies. However, the company does have drugs under review or in active clinical development.

In the past two years, Nanobiotix (NBTX) has reported FDA regulatory activity for the following drugs: NBTXR3 and JNJ-1900.

The most recent FDA-related event for Nanobiotix occurred on September 29, 2025, involving JNJ-1900. The update was categorized as "Updated data," with the company reporting: "NANOBIOTIX announced updated data from cohorts 1 and 2 of Study 1100, a multicenter Phase 1 dose escalation and expansion trial evaluating JNJ-1900 (NBTXR3) activated by radiation therapy ("RT") followed by anti-PD-1 immune checkpoint inhibitors (pembrolizumab or nivolumab; "ICIs") in patients with recurrent and/or metastatic head and neck squamous cell carcinoma ("R/M-HNSCC") that is naïve (cohort 1) or resistant (cohort 2) to prior anti-PD-1 therapy."

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

  • For the treatment of patients with stage 3, unresectable non-small cell lung cancer ("NSCLC"). - NBTXR3
  • for patients with cancer - JNJ-1900

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 10/1/2025 by MarketBeat.com Staff
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