CLN-081 PDUFA date: FDA decision expected February 27, 2027
The FDA is expected to decide on CLN-081 from Cullinan Therapeutics, Inc. in patients with locally advanced or metastatic EGFR ex20ins NSCLC who have previously received platinum-based chemotherapy by the PDUFA target action date of February 27, 2027. For patients with locally advanced or metastatic EGFR ex20ins NSCLC who have previously received platinum-based chemotherapy. nda filing. Extracted from SEC filing: EX-99.1
A PDUFA date is the FDA's target deadline to complete its review of a drug application — approval, a complete response letter (CRL), or an extension are all possible. What is a PDUFA date? This page is research information, not financial advice.
Source: sec.gov · Data checked October 16, 2026. Confirm dates against the company's or the FDA's announcement before acting.
Questions about this FDA decision
- When is the PDUFA date for CLN-081?
- The FDA's PDUFA target action date for CLN-081 is February 27, 2027. The FDA can act before that date, and the review can be extended.
- What is CLN-081 being reviewed for?
- The application under FDA review covers patients with locally advanced or metastatic EGFR ex20ins NSCLC who have previously received platinum-based chemotherapy.
- Which company is developing CLN-081?
- Cullinan Therapeutics, Inc. (CGEM).
- What can happen on a PDUFA date?
- The FDA approves the application, issues a complete response letter (CRL) listing what must be fixed before approval, or extends the review (typically by three months after a major amendment).