Nuvation Bio Inc. NUVB
Nuvation Bio Inc. (NYSE: NUVB) is an oncology drug developer. Its lead program, Taletrectinib (IBTROZI), is marketed for ROS1-positive non-small cell lung cancer. Its next catalyst on record is Safusidenib: Initiate pivotal Phase 3 (grade 2 IDH1-mutant glioma, ex-US) and Phase 2 (post-vorasidenib, US) (date not stated).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: Safusidenib — Initiate pivotal Phase 3 (grade 2 IDH1-mutant glioma, ex-US) and Phase 2 (post-vorasidenib, US) (date not stated). 1 catalyst on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| Taletrectinib (IBTROZI) | ROS1+ NSCLC | small molecule | MAA submission to EMA planned 1H 2026 (with Eisai) |
| Taletrectinib (TRUST-IV adjuvant) | Resected ROS1+ early-stage NSCLC | small molecule | — |
| Safusidenib | IDH1-mutant astrocytoma (SIGMA) | small molecule | Two new studies to initiate (pivotal Ph3 grade 2 glioma ex-US; Ph2 post-vorasidenib) |
Recent results and decisions
- Nov 3, 2025positive Pooled TRUST-I/II median duration of response matured to 50 months (August 2025 cutoff) in TKI-naive ROS1+ NSCLC.
Updated data continue to show IBTROZI’s unprecedented durability in TKI-naïve, advanced ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC), with median Duration of Response (DOR) increased to 50 months as of August 2025
Filing - Nov 3, 2025started First patient enrolled in the TRUST-IV Phase 3 adjuvant study (September 2025).
In September 2025, the Company enrolled the first patient in the TRUST-IV phase 3 study of IBTROZI for the adjuvant treatment of ROS1+ early-stage NSCLC.
Filing - Nov 3, 2025started First patient enrolled in the global randomized G203 study of safusidenib with registrational intent (300 patients planned).
In October 2025, the Company enrolled the first patient in the G203 study, a global, randomized study of safusidenib for maintenance treatment of high-grade IDH1-mutant glioma.
Filing
1 more on record.
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other approved oncology companies
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.