---
schema_version: "secwatch.filing_event.v1"
accession: "0000950170-25-010199"
form_type: "8-K"
ticker: "CGEM"
cik: "0001789972"
company_name: "Cullinan Therapeutics, Inc."
filed_at: "2025-01-29T23:59:59+00:00"
generated_at: "2026-05-27T07:12:31.915991+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Cullinan's zipalertinib meets primary endpoint in Phase 2b NSCLC trial; H2 2025 FDA submission planned

## Summary
- REZILIENT1 trial met primary endpoint of overall response rate in NSCLC with EGFR exon 20 insertion mutations after prior therapy.
- Safety profile generally consistent with previous data presentations; full results to be submitted for upcoming medical conference.
- Pending FDA discussions, companies plan to submit for U.S. regulatory approval in second half of 2025.
- Zipalertinib (CLN-081/TAS6417) is a monotherapy for patients who have received prior therapy.

## SEC filing metadata
- accession: 0000950170-25-010199
- form_type: 8-K
- ticker: CGEM
- cik: 0001789972
- company_name: Cullinan Therapeutics, Inc.
- filed_at: 2025-01-29T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1789972/000095017025010199/0000950170-25-010199-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1789972/000095017025010199/cgem-20250128.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0000950170-25-010199
- JSON: https://secwatch.observer/filing/0000950170-25-010199.json
- Plain text: https://secwatch.observer/filing/0000950170-25-010199.txt

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