Cullinan Therapeutics, Inc. CGEM
Cullinan Therapeutics, Inc. (Nasdaq: CGEM) is an oncology drug developer. Its lead program, zipalertinib (CLN-081/TAS6417), is in Phase 3 for EGFR exon 20 insertion NSCLC, previously treated. Its next catalyst on record is zipalertinib: FDA PDUFA target action date for NDA (February 27, 2027).
Upcoming catalysts
- February 27, 2027zipalertinib — FDA PDUFA target action date for NDA
The U.S. FDA assigned a Prescription Drug User Fee Act target action date of February 27, 2027.
- February 2027zipalertinib monotherapy — NDA seeking accelerated approval for zipalertinib monotherapy in second-line EGFR exon 20 insertion NSCLC remains under FDA review with PDUFA target action date of February 27, 2027.
An NDA seeking accelerated approval for zipalertinib monotherapy in this indication remains under FDA review, with a Prescription Drug User Fee Act (PDUFA) target action date of February 27, 2027.
- February 2027zipalertinib monotherapy — NDA for zipalertinib monotherapy in previously treated EGFR ex20ins NSCLC remains under FDA review with a PDUFA action date of February 27, 2027.
An NDA seeking accelerated approval for zipalertinib monotherapy in this indication remains under FDA review, with a Prescription Drug User Fee Act (PDUFA) target action date of February 27, 2027.
Next further out: CLN-049 — Clinical data update from dose escalation (Q4 2026). 5 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| zipalertinib (CLN-081) - NDA, 2L+ EGFR ex20ins NSCLC | EGFR ex20ins NSCLC (post-platinum) | small molecule | Phase 3 |
| zipalertinib REZILIENT3 (with chemotherapy, 1L) | 1L EGFR ex20ins NSCLC | small molecule | Phase 3 |
| CLN-978 (CD19xCD3 T cell engager) | SLE, RA, Sjogren's disease | antibody | Phase 1 |
| CLN-049 (FLT3xCD3 T cell engager) | relapsed/refractory AML, MDS | antibody | Phase 1 |
| Velinotamig (BCMAxCD3 T cell engager) | autoimmune diseases (SLE; autoimmune cytopenias) | antibody | Phase 1 |
Recent results and decisions
- Oct 2, 2026met Phase 3 REZILIENT3 trial met its primary endpoint demonstrating statistically significant and clinically meaningful improvement in median progression-free survival for zipalertinib plus chemotherapy versus chemotherapy alone.
The Phase 3 REZILIENT3 trial, which met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in median progression-free survival for zipalertinib plus chemotherapy compared to chemotherapy alone.
Filing - Oct 1, 2026submitted NDA submission initiated under FDA Real-Time Oncology Review for 1L zipalertinib plus chemotherapy; completion expected by year-end 2026.
Completion of the NDA submission is expected by year-end 2026.
Filing - Aug 12, 2026met Met primary endpoint of PFS at planned interim analysis (statistically significant, clinically meaningful improvement; numbers not given); IDMC recommended unblinding.
In this analysis, the study demonstrated a statistically significant and clinically meaningful improvement in PFS in the zipalertinib containing arm.
Filing
5 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
- Merck & Co., Inc. MRK
- Astrazeneca PLC AZN
- Bristol Myers Squibb Co BMY
- BeOne Medicines Ltd. ONC
- Revolution Medicines, Inc. RVMD
- Genmab A/S GMAB
- BioNTech SE BNTX
- 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.