Cullinan starts FDA filing after 6-month PFS gain
- Cullinan Therapeutics started an FDA application for zipalertinib plus chemotherapy after REZILIENT3 showed a 6-month median progression-free survival improvement.
- Cullinan shares closed October 1 at $14.53, down 5.34%, before the application announcement was released after market hours.
- Cullinan expects to complete the first-line application by year-end 2026 under the FDA’s Real-Time Oncology Review program.
Cullinan Therapeutics (NASDAQ:CGEM) initiated an FDA New Drug Application for first-line zipalertinib plus chemotherapy after REZILIENT3 showed a 6.0-month median progression-free survival improvement.
The Phase 3 trial reported median progression-free survival of 14.5 months with zipalertinib plus chemotherapy, compared with 8.5 months for chemotherapy alone.
The FDA’s Real-Time Oncology Review program allows clinical data to be submitted before the full application, and Cullinan expects to complete the filing by year-end 2026.
The company is eligible for a $100 million milestone upon first-line U.S. approval, while a separate second-line approval could trigger a $30 million payment.
Cullinan also has a separate zipalertinib monotherapy application under FDA review with a February 27, 2027 target action date.
Meanwhile, Cullinan shares closed October 1 down 5.34% at $14.53 before the first-line filing announcement was released after hours.
Cullinan and Taiho are developing zipalertinib in the U.S., while Cullinan is also advancing T-cell engager programs including CLN-978, velinotamig and CLN-049.
Recent company updates included September REZILIENT3 results and fourth-quarter 2026 clinical-data plans, following Cullinan’s August second-quarter financial update and earlier CLN-049 development progress.
