---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-26-411011"
form_type: "8-K"
ticker: "CGEM"
cik: "0001789972"
company_name: "Cullinan Therapeutics, Inc."
filed_at: "2026-10-01T23:35:44+00:00"
generated_at: "2026-10-12T14:29:55.606364+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

# Cullinan starts FDA NDA submission for zipalertinib combo in 1L EGFR ex20ins NSCLC under RTOR

## Summary
- NDA submission initiated for zipalertinib plus platinum-based chemotherapy in previously untreated, locally advanced or metastatic EGFR exon 20 insertion NSCLC.
- Submission is under the FDA's Real-Time Oncology Review program; completion of the NDA submission expected by year-end 2026.
- Based on Phase 3 REZILIENT3, which met its primary endpoint with a statistically significant improvement in median PFS vs chemotherapy alone; data presented at IASLC 2026 WCLC Presidential Symposium.
- A separate NDA seeking accelerated approval for zipalertinib monotherapy in second-line EGFR ex20ins NSCLC remains under FDA review, with a PDUFA target action date of February 27, 2027.
- Cullinan is eligible for $30.0 million and up to $100.0 million in Taiho milestone payments upon U.S. second-line and first-line approvals, respectively.

## SEC filing metadata
- accession: 0001193125-26-411011
- form_type: 8-K
- ticker: CGEM
- cik: 0001789972
- company_name: Cullinan Therapeutics, Inc.
- filed_at: 2026-10-01T23:35:44+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.6
- calibrated_materiality_score: 0.6
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1789972/000119312526411011/0001193125-26-411011-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1789972/000119312526411011/cgem-20261001.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-26-411011
- JSON: https://secwatch.observer/filing/0001193125-26-411011.json
- Plain text: https://secwatch.observer/filing/0001193125-26-411011.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.