Nuvation Bio Inc. NUVB
Nuvation Bio Inc. (NYSE: NUVB) is an oncology drug developer. Its lead program, Safusidenib, is in Phase 3 for IDH1-mutant astrocytoma and grade 2 IDH1-mutant glioma. Its next catalyst on record is Taletrectinib: European Medicines Agency MAA decision (date not stated).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: Taletrectinib — European Medicines Agency MAA decision (date not stated). 2 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| IBTROZI (taletrectinib) | ROS1-positive NSCLC | small molecule | Approved |
| Safusidenib | IDH1-mutant astrocytoma (high-risk features) | small molecule | Phase 3 |
| Safusidenib | Grade 2 IDH1-mutant glioma | small molecule | Phase 3 |
| Taletrectinib | ROS1+ NSCLC (adjuvant treatment) | small molecule | Phase 3 |
| Safusidenib | Grade 2 or 3 IDH1-mutant glioma progressed after vorasidenib | small molecule | Phase 2 |
Recent results and decisions
- approval FDA approved sNDA for IBTROZI updating label to reflect median duration of response of 49.7 months in TKI-naïve ROS1+ NSCLC patients.
In September 2026, Nuvation Bio announced that the U.S. Food and Drug Administration (FDA) approved a supplemental New Drug Application (sNDA) for IBTROZI, four months ahead of the January 4, 2027, target action date.
Filing - n/a FDA granted Fast Track Designation to safusidenib for the treatment of IDH1-mutant glioma.
In August 2026, Nuvation Bio announced that the FDA granted Fast Track Designation to safusidenib for the treatment of IDH1-mutant glioma.
Filing - started Pivotal Phase 3 study (G307) initiated in patients with grade 2 IDH1-mutant glioma outside the U.S.
Initiation of a pivotal Phase 3 study (G307) in patients with grade 2 IDH1-mutant glioma outside the U.S.
Filing
3 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 phase 3 oncology companies
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- Moderna, Inc. MRNA
- Revolution Medicines, Inc. RVMD
- Genmab A/S GMAB
- BioNTech SE BNTX
- Guardant Health, Inc. GH
- Exelixis, Inc. EXEL
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.