07:45 AM EDT, 08/28/2025 (MT Newswires) -- Telix Pharmaceutical (TLX) said Thursday the US Food and Drug Administration has requested additional data on its biologics license application for Zircaix (TLX250-CDx), an investigational PET agent for diagnosing clear cell renal cell carcinoma.

The FDA identified deficiencies in the chemistry, manufacturing, and controls package and asked for additional data to establish comparability between the drug product used in the phase 3 clinical trial and the manufacturing process for commercial use.

Telix said the issues are "readily addressable" and that it will request a Type A meeting with the FDA to determine a timeframe for resubmission, adding that the FDA request does not impact its 2025 revenue guidance.

Telix shares were down by more than 17% in premarket trading.