TLX250-CDx PDUFA date: FDA decision expected November 15, 2026

The FDA is expected to decide on TLX250-CDx from Telix Pharmaceuticals Ltd in clear cell renal cell carcinoma by the PDUFA target action date of November 15, 2026. For clear cell renal cell carcinoma. NDA filing. Extracted from SEC filing: 6-K

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.