Monitor for timing of NANORAY-312 final analysis readout, which could act as a catalyst. The accelerated timeline may bring forward potential regulatory submissions and milestone payments, but no revenue is guaranteed until approval.
Price Chart
Executive Summary
Nanobiotix announced FDA acceptance of a protocol amendment to its pivotal NANORAY-312 study for JNJ-1900 (NBTXR3) in head and neck cancer. The amendment eliminates the interim analysis and modifies the final analysis to require fewer events and occur sooner, potentially accelerating the registration pathway. No financial figures or approval decision were disclosed.
Key Facts
- FDA accepted protocol amendment for NANORAY-312 study of JNJ-1900 (NBTXR3) in head and neck cancer.
- Amendment eliminates planned interim analysis and modifies final analysis to be conducted sooner with fewer events.
- Nanobiotix believes this could accelerate and expand global registration pathway.
- Company is eligible for milestone payments from J&J, but no specific amounts or timing provided.
Financial Impact
No financial figures disclosed; milestone payments from J&J are contingent on future regulatory and development milestones.
Risk Factors
- Clinical trial results may not support regulatory approval.
- Milestone payments depend on achieving specific development and regulatory events, which may not occur as anticipated.
- Johnson & Johnson controls the trial timeline, and further changes could occur.
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 1 press release from GlobeNewswire.
| Document | Accession Number |
|---|---|
| PRESS-RELEASE Data (Synthetic) | press-3287230 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Oct 26, 2026 1d ago | 6-K | $30.26 | awaiting T+20 | — | $31.53 (+4.20%) |
Oct 20, 2026 6d ago | 6-K | $25.83 | awaiting T+20 | — | $31.53 (+22.07%) |
Oct 1, 2026 25d ago | 6-K | $25.75 | awaiting T+20 | — | $31.53 (+22.45%) |
Oct 1, 2026 25d ago | Press Release | $25.75 | awaiting T+20 | — | $31.53 (+22.45%) |
Sep 24, 2026 4w ago | 6-K | $33.31 $29.36 | ▲ +11.86% | ▲ +10.38% | $31.53 (+5.34%) |
Sep 24, 2026 4w ago | 6-K | $33.31 $29.36 | ▼ −11.86% | ▼ −10.38% | $31.53 (−5.34%) |
Sep 24, 2026 4w ago | Press Release | $33.31 $29.36 | ▼ −11.86% | ▼ −10.38% | $31.53 (−5.34%) |
Sep 22, 2026 4w ago | Press Release | $35.24 $25.83 | ▼ −26.70% | ▼ −27.39% | $31.53 (−10.53%) |
Sep 14, 2026 6w ago | 6-K | $35.73 $23.40 | ▼ −34.51% | ▼ −36.77% | $31.53 (−11.75%) |
Jul 31, 2026 12w ago | 6-K | $38.89 $40.64 | ▲ +4.50% | ▲ +3.26% | $31.53 (−18.93%) |
US Market Status
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