Clinical trials
catalyst calendar across sponsors →Studies where NUVL 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.
4 interventional · 2 expanded access
Held by 19 tracked-famous managers (Balyasny Asset Management L.P., MILLENNIUM MANAGEMENT LLC, SOROS FUND MANAGEMENT LLC, RENAISSANCE TECHNOLOGIES LLC, TWO SIGMA INVESTMENTS, LP, +14 more) · FINRA short interest 1.0 days to cover (settled 2026-07-15) · insider 90d: 0 buys / 21 sells · government filings 180d: none disclosed
| Study | Phase | Status | Interventions | Conditions | Enrollment | Primary completion | Readout in | Updated |
|---|---|---|---|---|---|---|---|---|
| Neladalkib (NVL-655) for TKI-naive Patients With Advanced ALK-Positive NSCLCNCT06765109Progression-free survival (PFS) per blinded independent central review (BICR)Randomized · Single-masked · Treatment | Phase 3 | Recruiting | Drug: Neladalkib (NVL-655), Alectinib | Non-small Cell Lung Cancer, Anaplastic Lymphoma Kinase-positive | 450 | Dec 2029 | ≤ 1,230 d | 2026-07-21 |
| A Study of Zidesamtinib (NVL-520) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ROS1 Rearrangement (ARROS-1)NCT05118789Maximum Tolerated Dose (MTD) (Phase 1)Non-randomized · Open-label · Treatment | Phase 1/2 | Recruiting | Drug: Zidesamtinib (NVL-520) | Locally Advanced Solid Tumor, Metastatic Solid Tumor | 359 | 2027-12-31 | in 499 d | 2025-10-24 |
| A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)NCT05384626Dose limiting toxicities (DLTs) (Phase 1)Non-randomized · Open-label · Treatment | Phase 1/2 | Recruiting | Drug: Neladalkib (NVL-655), Midazolam, Repaglinide, Itraconazole | Locally Advanced Solid Tumor, Metastatic Solid Tumor | 840 | Dec 2027 | ≤ 499 d | 2026-05-27 |
| A Study of NVL-330 in Patients With Advanced or Metastatic HER2-altered NSCLC (HEROEX-1)NCT06521554Recommended Phase 2 Dose (RP2D)Non-randomized · Open-label · Treatment | Phase 1 | Recruiting | Drug: NVL-330 | Locally Advanced Solid Tumor, Metastatic Solid Tumor | 200 | Jan 2027 | ≤ 165 d | 2026-02-25 |
| Expanded Access Program of Zidesamtinib (NVL-520) for Patients With Advanced ROS1+ NSCLC or Other ROS1+ Solid TumorsNCT06797362expanded access | — | Available | Drug: NVL-520 | Non Small Cell Lung Cancer, ROS1-positive Non-Small Cell Lung Cancer (NSCLC) | — | — | — | 2026-06-15 |
| Expanded Access Program of Neladalkib (NVL-655) for Patients With Advanced ALK+ NSCLC or Other ALK+ Solid TumorsNCT06834074expanded access | — | Available | Drug: NVL-655 | Non Small Cell Lung Cancer, ALK-positive Non-small Cell Lung Cancer (NSCLC) | — | — | — | 2026-08-06 |
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