Telix Pharmaceuticals Limited (TLX,TLX.AX) announced that it has received a Complete Response Letter (CRL) from the U.S. FDA regarding its application to approve TLX250-CDx (Zircaix), a PET imaging agent used to help diagnose kidney cancer (specifically clear cell renal cell carcinoma).
TLX closed wednesday regular tarding at $12.10 down $0.44 or 3.51%. The stock further dropped $2.20 or 18.18%.
The FDA found issues with the drug's manufacturing and quality control information. It has asked Telix to provide more data showing that the product used in clinical trials is similar to the one they plan to produce commercially. The FDA also flagged problems at two third-party manufacturing partners, which must be fixed before Telix can reapply.
Telix plans to meet with the FDA soon to discuss how to address these issues and when they can resubmit the application. Despite this setback, TLX250-CDx still holds Breakthrough Therapy and Priority Review status, showing its potential to meet an important medical need.
Importantly, this FDA feedback does not affect Telix's 2025 revenue forecast, since the company had not included sales from this product in its guidance. In the meantime, Telix will continue offering TLX250-CDx to patients through the FDA's expanded access program, pending further discussions.
For More Such Health News, visit rttnews.com
For comments and feedback contact: editorial@rttnews.com
Business News
April 17, 2026 15:29 ET The ongoing conflict in the Middle East continues to raise concerns for policymakers who worry about the impact of the supply shock and high energy prices on the real economy. Producer price data and various survey results on the housing market were the main news from the U.S. this week. In Europe, industrial production data for the euro area gained attention. GDP figures out of China and the policy move by the Singapore central bank were in focus in Asia.