Clinical trials
catalyst calendar across sponsors →Studies where NUVB is the lead sponsor, as filed with ClinicalTrials.gov. Completion dates are the sponsor's own projected windows and are revised as a study runs. Active studies first, then completed and stopped — newest readout first within each.
18 interventional · 1 expanded access
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| Study | Phase | Status | Interventions | Conditions | Enrollment | Primary completion | Readout in | Updated |
|---|---|---|---|---|---|---|---|---|
| Safety and Efficacy Study of Safusidenib in Participants With IDH1-Mutant Glioma Who Discontinued Vorasidenib Treatment Due to Progressive DiseaseNCT07703436Objective Response Rate (ORR) per modified Response Assessment in Neuro-Oncology (RANO) 2.0 assessed by Blinded Independent Central Review (BICR)Open-label · Treatment | Phase 2 | Not yet recruiting | Drug: Safusidenib | Grade 2 IDH1-mutant Glioma, Grade 3 IDH1-mutant Glioma, Glioma, IDH1-mutant Glioma, Oligodendroglioma, Oligodendroglioma IDH-1 Mutant and 1/p19q-codeleted, Astrocytoma IDH Mutant Grade 3, Astrocytoma IDH Mutant Grade 2 | 40 | Sep 2030 | ≤ 1,502 d | 2026-08-11 |
| Phase 3 Study of Taletrectinib vs Placebo as an Adjuvant Therapy in ROS1 Positive NSCLC (TRUST-IV)NCT07154706Primary Outcome Measure: To compare the efficacy of taletrectinib with that of placebo, as measured by disease-free survival (DFS) by investigator assessment.Randomized · Triple-masked · Treatment | Phase 3 | Recruiting | Drug: Taletrectinib, Placebo | Non-small Cell Lung Cancer (NSCLC) | 180 | 2030-08-30 | in 1,471 d | 2026-05-19 |
| Safety and Efficacy Study of Safusidenib in Participants With Grade 2 IDH1-Mutant GliomaNCT07712757Progression Free Survival (PFS) assessed by Blinded Independent Central Review (BICR) per modified Response Assessment in Neuro-Oncology (RANO) 2.0Randomized · Quadruple-masked · Treatment | Phase 3 | Not yet recruiting | Drug: Safusidenib, Placebo | Grade 2 Glioma (Astrocytoma or Oligodendroglioma) With an IDH1 Mutation, Astrocytoma IDH Mutant Grade 2, Oligodendroglioma, Oligodendroglioma IDH-mutant and 1p/19q-codeleted, IDH-mutant Gliomas | 140 | May 2029 | ≤ 1,015 d | 2026-07-17 |
| A Phase III Study Comparing Taletrectinib With Standard Therapy in ROS1 Positive Locally Advanced or Metastatic Non-small Cell Lung Cancer PatientsNCT06564324PFS (Assessed by BIRC)Randomized · Open-label · Treatment | Phase 3 | Recruiting | Drug: Taletrectinib, Crizotinib | Non Small Cell Lung Cancer | 194 | Jan 2029 | ≤ 895 d | 2026-04-13 |
| SIGMA (Safusidenib in IDH1 Mutant Glioma Maintenance)NCT05303519Part 1: Incidence of adverse events (AEs) and serious adverse events (SAEs)Randomized · Quadruple-masked · Treatment | Phase 3 | Recruiting | Drug: safusidenib, Placebo | Glioma, Astrocytoma, Grade IV, IDH1-mutant Glioma, Astrocytoma, IDH-Mutant, Grade 3, Astrocytoma, IDH-Mutant, Grade 4, Astrocytoma, IDH-Mutant, Grade 2, Oligodendroglioma, Oligodendroglioma, IDH-Mutant and 1p/19q-Codeleted | 365 | 2028-12-01 | in 834 d | 2026-07-01 |
| Safety and Efficacy Study of NUV-1511 in Adult Patients With Advanced Solid TumorsNCT06334432Phase 1: Assess safety and tolerability of NUV-1511 in advanced solid tumorsNon-randomized · Open-label · Treatment | Phase 1/2 | Active, not recruiting | Drug: NUV-1511 | Advanced Solid Tumor, HER2-negative Breast Cancer, Metastatic Castration-resistant Prostate Cancer (mCRPC), Pancreatic Cancer, Platinum-resistant Ovarian Cancer (PROC) | 466 | Mar 2027 | ≤ 223 d | 2026-01-14 |
| Study on the Effect of Famotidine on Pharmacokinetics of TaletrectinibNCT07742384Cmax of TaletrectinibNon-randomized · Open-label · Treatment | Phase 1 | Not yet recruiting | Drug: Taletrectinib, Taletrectinib, Famotidine, Taletrectinib, Famotidine, Taletrectinib, Taletrectinib, Famotidine, Taletrectinib,Famotidine | Healthy Adult Participants | 56 | 2027-02-02 | in 166 d | 2026-08-03 |
| Taletrectinib Phase 2 Global Study in ROS1 Positive NSCLCNCT04919811Objective response rate (ORR) by independent radiology review committee (IRC)Open-label · Treatment | Phase 2 | Active, not recruiting | Drug: Taletrectinib | Non Small Cell Lung Cancer | 217 | 2025-06-11actual | — | 2026-01-07 |
| A Study of AB-106 in Subjects With Advanced NSCLC Harboring ROS1 Fusion GeneNCT04395677Best overall response (BOR) by IRCOpen-label · Treatment | Phase 2 | Active, not recruiting | Drug: AB-106 | Non Small Cell Lung Cancer | 173 | 2024-06-07actual | — | 2026-02-06 |
| Study of NUV-422 in Combination With Fulvestrant in Patients With HR+HER2- aBCNCT05191004Phase 1b Dose Escalation: Safety and tolerability of NUV-422 in combination with fulvestrant to determine the recommended Phase 2 combination dose (RP2cD)Randomized · Open-label · Treatment | Phase 1/2 | Withdrawnsponsor's stated reason: Sponsor decision | Drug: NUV-422, Fulvestrant | Advanced Breast Cancer, Metastatic Breast Cancer, Breast Cancer, Breast Carcinoma, Cancer of the Breast, Cancer of Breast, Malignant Tumor of Breast, Breast Tumor | 0 | Jun 2025 | — | 2023-07-11 |
| Study of NUV-422 in Combination With Enzalutamide in Patients With mCRPCNCT05191017Phase 1b Dose Escalation: Safety and tolerability of NUV-422 in combination with enzalutamide to determine the recommended Phase 2 combination dose (RP2cD)Non-randomized · Open-label · Treatment | Phase 1/2 | Withdrawnsponsor's stated reason: Sponsor decision | Drug: NUV-422, Enzalutamide | Prostate Cancer, Prostatic Cancer, Cancer of Prostate, Cancer of the Prostate, Prostate Neoplasm, Castrate Resistant Prostate Cancer, Castration Resistant Prostatic Cancer, Castration Resistant Prostatic Neoplasms | 0 | Jan 2025 | — | 2022-08-05 |
| Phase II Study of AB-106 to Treat Patients With Solid Tumors With NTRK Gene FusionNCT04617054Objective response rate (ORR)Open-label · Treatment | Phase 2 | Terminatedsponsor's stated reason: The study was discontinued early by the Sponsor for business reasons on 06 Dec 2024 | Drug: AB-106 | Solid Tumor | 14 | 2024-12-06actual | — | 2026-01-21 |
| NUV-868 as Monotherapy and in Combination With Olaparib or Enzalutamide in Adult Patients With Advanced Solid TumorsNCT05252390Phase 1 Monotherapy Dose Escalation: Safety and tolerability of NUV-868 to determine the recommended Phase 2 dose (RP2D)Non-randomized · Open-label · Treatment | Phase 1 | Terminatedsponsor's stated reason: The Sponsor has achieved its objectives. | Drug: NUV-868, Olaparib, Enzalutamide | Advanced Solid Tumor, Ovarian Cancer, Ovary Cancer, Cancer of Ovary, Cancer of the Ovary, Ovary Neoplasm, Pancreatic Cancer, Pancreas Cancer, Cancer of Pancreas, Cancer of the Pancreas, Pancreas Neoplasm, Prostate Cancer, Prostatic Cancer, Cancer of Prostate, Cancer of the Prostate, Prostate Neoplasm, Castrate Resistant Prostate Cancer, Castration Resistant Prostatic Cancer, Castration Resistant Prostatic Neoplasms, Triple-negative Breast Cancer, Triple Negative Breast Cancer, Triple Negative Breast Neoplasms, Breast Cancer, Breast Carcinoma, Cancer of Breast, Cancer of the Breast, Breast Tumor | 82 | 2024-07-15actual | — | 2025-11-06 |
| Study the Effect of Omeprazole on AB-106 PharmacokineticsNCT05609929CmaxOpen-label · Treatment | Phase 1 | Completed | Drug: Multiple administration of omeprazole Single administration of AB-106 | Pharmacokinetic Study | 24 | 2023-01-20actual | — | 2024-11-21 |
| Study of NUV-422 in Adults With Recurrent or Refractory High-grade Gliomas and Solid TumorsNCT04541225Phase 1 Dose Escalation: Safety and tolerability of NUV-422 to determine the recommended Phase 2 dose (RP2D)Open-label · Treatment | Phase 1 | Terminatedsponsor's stated reason: Sponsor decision | Drug: NUV-422 | Glioma, Glioma, Malignant, Glioma, Mixed, Glial Cell Tumors, Breast Cancer, Breast Carcinoma, Cancer of Breast, Cancer of the Breast, Breast Tumor, Malignant Tumor of Breast, Advanced Breast Cancer, Advanced Breast Carcinoma, Metastatic Breast Cancer, Metastatic Breast Carcinoma, Prostate Cancer, Prostatic Cancer, Cancer of Prostate, Cancer of the Prostate, Prostate Neoplasm, Castrate Resistant Prostate Cancer, Castration-resistant Prostate Cancer, Castration Resistant Prostatic Neoplasms, Glioblastoma, Recurrent Glioblastoma | 74 | 2022-08-31actual | — | 2023-07-14 |
| A Study of AB-106 in Chinese Healthy Adult Men Evaluated the Effects of Itraconazole and Rifampicin on AB-106 PKNCT05357820AB-106 PK Exposure ParametersNon-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: AB-106, Itraconazole, AB-106, Rifampicin | Solid Tumor | 56 | 2021-12-03actual | — | 2024-11-21 |
| A Study on the Effect of AB-106 on the Pharmacokinetics of DigoxinNCT05357911The PK exposure parameters of digoxinOpen-label · Treatment | Phase 1 | Completed | Drug: AB-106, digoxin | Solid Tumor | 16 | 2021-08-20actual | — | 2024-11-21 |
| A First-in-human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of DS-6051bNCT02279433Part 1: Number of participants with dose-limiting toxicitiesOpen-label · Treatment | Phase 1 | Completed | Drug: DS6051b | Solid Tumors | 46 | Mar 2019actual | — | 2025-06-24 |
| Expanded Access Program of Taletrectinib in Patients With Advanced or Metastatic ROS1-Positive NSCLCNCT06841874expanded access | — | No longer available | Drug: Taletrectinib | Lung Neoplasms, Respiratory Tract Neoplasms, Thoracic Neoplasms, Neoplasms by Site, Neoplasms, Lung Diseases, Respiratory Tract Diseases, Carcinoma, Bronchogenic Carcinoma, Non Small Cell Carcinoma of the Lung, ROS1-positive Non-Small Cell Lung Cancer (NSCLC) | — | — | — | 2025-12-24 |
Primary completion is the date the sponsor filed with the registry — their own projection, revised whenever they revise it, unless the row is marked actual.
Source: ClinicalTrials.gov, retrieved 2026-08-19