Telix Pharmaceuticals Advances FDA Resubmissions for TLX101-CDx and TLX250-CDx

Reuters12-22 05:38

<a href="https://laohu8.com/S/TLX.AU">Telix Pharmaceuticals</a> Advances FDA Resubmissions for TLX101-CDx and TLX250-CDx

Telix Pharmaceuticals Ltd. has provided an update on its regulatory review processes for several precision medicine products. The company recently participated in Type A meetings with the U.S. Food and Drug Administration (FDA) to address Complete Response Letters (CRLs) received for TLX101-CDx (Pixclara®, 18F-floretyrosine) and TLX250-CDx (Zircaix®, 89Zr-DFO-girentuximab). Telix is finalizing resubmissions for both candidates, having reached alignment with the FDA on remediation of identified deficiencies, particularly regarding the chemistry, manufacturing, and controls $(CMC)$ packages. Additionally, the FDA has granted Telix an extra meeting in January to review plans for providing further data on TLX250-CDx. Expanded Access Programs for both candidates remain active, allowing continued patient access during the regulatory process.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Telix Pharmaceuticals Ltd. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9615701-en) on December 21, 2025, and is solely responsible for the information contained therein.

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The company recently participated in Type A meetings with the U.S. Food and Drug Administration (FDA) to address Complete Response Letters (CRLs) received for TLX101-CDx (Pixclara®, 18F-floretyrosine) and TLX250-CDx (Zircaix®, 89Zr-DFO-girentuximab). Telix is finalizing resubmissions for both candidates, having reached alignment with the FDA on remediation of identified deficiencies, particularly regarding the chemistry, manufacturing, and controls <a href=\"https://laohu8.com/S/CMC\">$(CMC)$</a> packages. Additionally, the FDA has granted Telix an extra meeting in January to review plans for providing further data on TLX250-CDx. 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