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
NANORAY-312, 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.
NANORAY-312 FDA Regulatory Events
NANORAY-312 is a drug developed by Nanobiotix for the following indication: head and neck squamous cell cancers.
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:
- NANORAY-312
- Announced Date:
- October 24, 2025
- Estimated Event Date Range:
- January 1, 2027 - June 30, 2027
- Target Action Date:
- H1 2027
- Indication:
- head and neck squamous cell cancers.
Announcement
Nanobiotix estimates that NANORAY-312 interim data will be analyzed and reported, after both the requisite number of events have been observed and the last patient has been recruited, in 1H2027.
AI Summary
Nanobiotix announced it has completed transferring sponsorship of its Phase 3 NANORAY-312 trial to Johnson & Johnson. After reviewing the latest data, the company estimates that interim results will be analyzed and reported in the first half of 2027—once the required number of events have occurred and the final patient is recruited.
Going forward, J&J will provide all future guidance and updates on its JNJ-1900 (NBTXR3) studies, including NANORAY-312. Nanobiotix will continue to share clinical development news and guidance for trials it still sponsors, as well as studies run by The University of Texas MD Anderson Cancer Center.
JNJ-1900 (NBTXR3) is an innovative cancer therapy that injects hafnium oxide nanoparticles directly into tumors and activates them with radiotherapy. The global NANORAY-312 study is evaluating this approach in patients with locally advanced head and neck cancers.
Read Announcement
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.
- Drug:
- JNJ-1900
- Announced Date:
- October 24, 2025
- Indication:
- for patients with cancer
Announcement
NANOBIOTIX announced updates to the JNJ-1900 (NBTXR3) clinical development program.
AI Summary
Nanobiotix today announced key updates to its JNJ-1900 (NBTXR3) clinical program. The company has transferred sponsorship and full operational control of its global Phase 3 study, NANORAY-312, to Johnson & Johnson. This study tests a one-time intratumoral injection of hafnium oxide nanoparticles activated by radiotherapy in head and neck cancer.
After reviewing the latest trial information, Nanobiotix expects to analyze and report interim results in the first half of 2027. This timing depends on reaching the required number of events and completing patient enrollment.
Going forward, J&J will provide guidance on NANORAY-312 and other JNJ-1900 studies it sponsors. Nanobiotix will continue sharing updates on its own sponsored trials and those run with The University of Texas MD Anderson Cancer Center, ensuring clear communication of progress.
Read Announcement- Drug:
- JNJ-1900
- Announced Date:
- September 29, 2025
- Indication:
- for patients with cancer
Announcement
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.
AI Summary
Nanobiotix shared updated Phase 1 results from cohorts 1 and 2 of Study 1100, which tests JNJ-1900 (NBTXR3) activated by radiation therapy (RT) followed by anti-PD-1 drugs pembrolizumab or nivolumab in patients with recurrent or metastatic head and neck squamous cell carcinoma (R/M-HNSCC) who are either naïve or resistant to prior anti-PD-1 treatment.
Treatment was well tolerated in 103 heavily pre-treated patients, with consistent injection feasibility at the recommended dose. Most side effects were low grade: 27 patients had any-grade events related to JNJ-1900 and 32 to the injection procedure. Only nine patients experienced grade 3 or higher events linked to the nanoparticle or injection.
Among evaluable patients naïve to anti-PD-1 therapy (n=41), disease control rate (DCR) per RECIST 1.1 was 63% and objective response rate (ORR) 37%, with median overall survival (mOS) of 15.5 months. In resistant patients (n=50), DCR was 74%, ORR 32%, and mOS 11.4 months. These encouraging safety and efficacy signals support further study in randomized trials.
Read Announcement
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.
- Drug:
- NBTXR3
- Announced Date:
- September 17, 2025
- Indication:
- For the treatment of patients with stage 3, unresectable non-small cell lung cancer ("NSCLC").
Announcement
NANOBIOTIX announced new results focused on patients with primary cutaneous melanoma from the ongoing Phase 1 Study 1100 evaluating JNJ-1900 (NBTXR3) in combination with immune checkpoint inhibitors (pembrolizumab or nivolumab) for patients with advanced cancers.
AI Summary
NanoBiotix presented new Phase 1 Study 1100 results in patients with primary cutaneous melanoma whose cancer had progressed after multiple therapies, including anti-PD-1 drugs. Data were shared at the ImmunoRad conference in Paris on September 17, 2025.
In this trial, 21 patients received a one-time intratumoral injection of NBTXR3 (JNJ-1900) at the recommended Phase 2 dose (33% of gross tumor volume), followed by radiotherapy and pembrolizumab or nivolumab. Injection was feasible in all cases, and most treatment-related side effects were mild to moderate (grades 1–3), with only a few events linked directly to NBTXR3.
Among 19 evaluable patients, the objective response rate was 47.4% (9/19), including four complete and five partial responses. The disease control rate reached 78.9% overall and 100% in injected tumors. Median overall survival was 14.6 months. Deeper local responses often coincided with systemic tumor regression.
Investigators believe these encouraging safety and early efficacy signals support further randomized trials. NanoBiotix will host a conference call on September 18, 2025 to discuss these findings.
Read Announcement- Drug:
- NBTXR3
- Announced Date:
- May 5, 2025
- Indication:
- For the treatment of patients with stage 3, unresectable non-small cell lung cancer ("NSCLC").
Announcement
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.
AI Summary
NANOBIOTIX presented full Phase 1 study results of JNJ-1900 (NBTXR3) in patients with locally advanced or borderline resectable pancreatic cancer. The study, conducted by MD Anderson, showed that the treatment has a favorable safety profile and that the injection method is feasible. Among the 22 patients treated, the median overall survival was 23 months from diagnosis. Moreover, the median local progression-free survival reached 13.3 months shortly after completing radiation treatment.
Exploratory biomarker analyses revealed that increased circulating tumor mutational burden was associated with better local control and overall survival, while CA19-9 normalization—observed in 59% of patients—also correlated with longer survival. Based on these encouraging results, investigators believe that further evaluation in a randomized study is warranted, including an ongoing cohort that combines standard-of-care chemotherapy with radiotherapy-activated JNJ-1900.
Read Announcement- Drug:
- NBTXR3
- Announced Date:
- April 30, 2025
- Indication:
- For the treatment of patients with stage 3, unresectable non-small cell lung cancer ("NSCLC").
Announcement
NANOBIOTIX announced the presentation of full results from the completed dose escalation and dose expansion parts of a Phase 1 study evaluating JNJ-1900 (NBTXR3) in patients with locally advanced or borderline resectable pancreatic cancer.
AI Summary
NANOBIOTIX announced it will present the full results from a Phase 1 study that evaluated JNJ-1900 (NBTXR3) in patients with locally advanced or borderline resectable pancreatic cancer. The study, conducted by The University of Texas MD Anderson Cancer Center, involved both a dose escalation part and a dose expansion part, following induction chemotherapy. The innovative treatment uses functionalized hafnium oxide nanoparticles activated by radiotherapy to induce tumor cell death and trigger an immune response.
Dr. Eugene Koay, the principal investigator, will present the study results at the ESTRO 2025 Annual Meeting on May 4th at 11:00 AM EDT / 5:00 PM CEST. Additionally, NANOBIOTIX will host a conference call on May 5th to review and discuss the findings, marking an important milestone that could shape future treatment possibilities for pancreatic cancer.
Read Announcement- Drug:
- NBTXR3
- Announced Date:
- March 27, 2025
- Indication:
- For the treatment of patients with stage 3, unresectable non-small cell lung cancer ("NSCLC").
Announcement
NANOBIOTIX announced the first data from the completed dose escalation part of a Phase 1 study sponsored by The University of Texas MD Anderson Cancer Center ("MD Anderson") evaluating radiotherapy-activated NBTXR3 (JNJ-1900)1 as a second or later line (2L+) therapy for patients with locally advanced non-small cell lung cancer ("NSCLC") amenable to re-irradiation.
AI Summary
NANOBIOTIX announced the first results from the completed dose escalation phase of a Phase 1 study sponsored by MD Anderson Cancer Center. The study evaluated the radiotherapy-activated NBTXR3 (JNJ-1900) as a second or later line treatment for patients with locally advanced non-small cell lung cancer (NSCLC) who are candidates for re-irradiation. In a group of 12 patients, the treatment showed a favorable safety profile with no dose-limiting toxicities and confirmed that intratumoral injections are feasible. Early survival data were promising, with a 12-month local progression-free survival rate of 64% (median of 18.6 months) and a 12-month overall survival rate of 83% (median of 30.2 months). Based on these encouraging findings, the recommended phase 2 dose was set at 33% of the gross tumor volume, and the study's expansion phase is now underway.
Read Announcement- Drug:
- NBTXR3
- Announced Date:
- March 20, 2025
- Indication:
- For the treatment of patients with stage 3, unresectable non-small cell lung cancer ("NSCLC").
Announcement
NANOBIOTIX announced poster presentations from two Phase 1 studies evaluating JNJ-1900 (NBTXR3) for patients with lung cancer (NSCLC) to be presented at the 2025 European Lung Cancer Conference ("ELCC").
AI Summary
NANOBIOTIX announced they will present new Phase 1 study results on JNJ-1900 (NBTXR3) at the 2025 European Lung Cancer Conference (ELCC). The data will focus on innovative treatment approaches for lung cancer patients, particularly those with non-small cell lung cancer (NSCLC).
One poster will show findings from a study where patients with inoperable, locoregional recurrent NSCLC received a one-time injection of NBTXR3 before re-irradiation. The second poster covers results from a study combining NBTXR3 with immune checkpoint inhibitors, such as nivolumab or pembrolizumab, in patients with lung metastases from NSCLC and other solid tumors. Both presentations provide early insights into the safety, feasibility, and potential treatment benefits, with sessions scheduled for March 28, 2025.
Read Announcement- Drug:
- NBTXR3
- Announced Date:
- January 21, 2025
- Indication:
- For the treatment of patients with stage 3, unresectable non-small cell lung cancer ("NSCLC").
Announcement
NANOBIOTIX announced that the first patient has been dosed in the CONVERGE study, a Phase 2 randomized controlled clinical trial evaluating potential first-in-class radioenhancer JNJ-1900 (NBTXR3) for the treatment of patients with Stage 3 unresectable non-small cell lung cancer receiving standard of care chemoradiation followed by consolidation durvalumab (NCT06667908).
AI Summary
NANOBIOTIX announced that the first patient has been dosed in the CONVERGE study, a Phase 2 randomized controlled trial. This trial is testing the potential first-in-class radioenhancer JNJ-1900 (NBTXR3) for patients with Stage 3 unresectable non-small cell lung cancer. In this study, patients receive standard chemoradiation and then consolidation durvalumab, with the goal of enhancing the effects of radiotherapy. The treatment involves a one-time intratumoral injection of NBTXR3, which is activated during radiotherapy to increase tumor cell death and possibly stimulate a longer-term immune response.
The CONVERGE study is sponsored by Janssen Pharmaceutica NV, a Johnson & Johnson Company, under a global license agreement. This early dosing marks an important step in evaluating the radioenhancer’s ability to meet the significant unmet needs for better treatments in this challenging cancer population.
Read Announcement- Drug:
- NBTXR3
- Announced Date:
- December 9, 2024
- Indication:
- For the treatment of patients with stage 3, unresectable non-small cell lung cancer ("NSCLC").
Announcement
NANOBIOTIX announced the completion of the dose escalation and dose expansion parts of a Phase 1 study evaluating radiotherapy("RT")-activated NBTXR3 (JNJ-1900) for patients with locally advanced pancreatic cancer ("LAPC") or borderline resectable pancreatic cancer ("BRPC").
AI Summary
NANOBIOTIX has completed the dose escalation and dose expansion stages of a Phase 1 study evaluating its radiotherapy-activated NBTXR3 (JNJ-1900) for patients with locally advanced or borderline resectable pancreatic cancer. In the trial at MD Anderson Cancer Center, 22 patients treated after initial chemotherapy showed a promising median overall survival of 23 months from diagnosis. This outcome compares favorably with historical results, suggesting that adding NBTXR3 to the treatment plan may enhance patient survival.
Following these encouraging results, the US FDA approved a protocol amendment to begin a new cohort study. This additional study will evaluate the combination of NBTXR3 with standard-of-care concurrent chemoradiation. Researchers plan to present the full data from the completed cohorts at a medical congress in the first half of 2025, highlighting the potential for improved treatment outcomes.
Read Announcement- Drug:
- NBTXR3
- Announced Date:
- May 21, 2024
- Estimated Event Date Range:
- July 1, 2024 - December 31, 2024
- Target Action Date:
- H2 2024
- Indication:
- For the treatment of patients with stage 3, unresectable non-small cell lung cancer ("NSCLC").
Announcement
Nanobiotix Announces Operational progress update on Nanobiotix nanoparticle-based therapy platforms beyond NBTXR3 expected in 2H2024
AI Summary
Nanobiotix announced plans to update its operational progress on nanoparticle-based therapy platforms beyond its lead candidate NBTXR3. The company, which is known for its innovative cancer treatment approach using NBTXR3, is working on developing three sequential platforms. While the global collaboration with Janssen remains focused on NBTXR3, Nanobiotix is also preparing to reveal advancements in its next-generation nanoparticle therapies.
This update, expected in the second half of 2024, will outline progress on new platforms that aim to improve treatment outcomes for cancer and potentially other diseases. Nanobiotix’s strategy involves leveraging revenues and data from NBTXR3 to expand its research and development efforts, paving the way for future therapies that could widen the scope of nanoparticle-based treatments in healthcare.
Read Announcement- Drug:
- NBTXR3
- Announced Date:
- May 21, 2024
- Indication:
- For the treatment of patients with stage 3, unresectable non-small cell lung cancer ("NSCLC").
Announcement
NANOBIOTIX announced updates to its corporate strategy designed to enable long-term growth in view of significant progress in the Company's collaboration for the co-development and global commercialization of lead therapeutic candidate NBTXR3.
AI Summary
NANOBIOTIX has updated its corporate strategy to drive long-term growth by building on remarkable progress in its global collaboration for co-developing and commercializing its lead product candidate, NBTXR3. This strategic revision focuses on leveraging the robust partnership with Janssen to optimize the development process and maximize the therapeutic potential of NBTXR3. Key changes include transferring the global sponsorship of the ongoing Phase 3 head and neck cancer trial and removing a previously planned futility analysis due to positive data from earlier studies. Additionally, the company will delay the interim analysis until after the recruitment phase concludes in the first half of 2026, helping ensure unbiased results. The update also reinforces NANOBIOTIX’s commitment to using revenue from NBTXR3’s success to support further advancements in nanoparticle-based therapy platforms.
Read Announcement- Drug:
- NBTXR3
- Announced Date:
- May 14, 2024
- Indication:
- For the treatment of patients with stage 3, unresectable non-small cell lung cancer ("NSCLC").
Announcement
NANOBIOTIX announced that the U.S. Food and Drug Administration ("US FDA") issued a Study May Proceed Letter for a randomized Phase 2 study evaluating NBTXR3 for the treatment of patients with stage 3, unresectable non-small cell lung cancer ("NSCLC"). An IND to support this trial was submitted by the global trial sponsor, Johnson & Johnson Enterprise Innovation Inc., a Johnson & Johnson company.
AI Summary
NANOBIOTIX recently announced that the U.S. Food and Drug Administration (US FDA) has issued a Study May Proceed Letter. This approves the randomized Phase 2 study that will evaluate NBTXR3, a novel therapeutic, for patients diagnosed with stage 3, unresectable non-small cell lung cancer (NSCLC). The study is designed to determine the safety and effectiveness of NBTXR3 in combination with other treatments, offering new hope for patients battling advanced NSCLC.
The Investigational New Drug (IND) application required for this trial was submitted by Johnson & Johnson Enterprise Innovation Inc., a subsidiary of Johnson & Johnson, which is acting as the global trial sponsor. This development is an important step forward in exploring new cancer treatment options and highlights the ongoing collaboration between industry leaders and regulatory authorities to bring innovative therapies to patients in need.
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