Telix’s TLX101-CDx granted fast track designation by US FDA

The US FDA has granted fast-track designation to Telix Pharmaceuticals (ASX:TLX) investigational glioma imaging product Pixclara (TLX101-CDx).

The company said the granted designation is for the characterisation of progressive or recurrent glioma using positron emission tomography (PET). It said it is in the final stages of preparing its US New Drug Application (NDA) for TLX101-CDx in this initial indication in adult and paediatric patients.

Telix has an exclusive research collaboration and data license agreement with the University of California, San Francisco (UCSF). The company said the collaboration supporting joint development and commercialisation will enable Telix to offer TLX101-CDx access as a commercial product in the US, subject to regulatory approval.

Telix has selected PharmaLogic as its commercial manufacturing and pharmacy distribution partner to supply finished unit doses of TLX101-CDx to the US market.

Richard Valeix, group chief commercial officer at Telix, said, “These milestones represent significant progress as we bring this investigational product closer to market in the US and commercial launch. PharmaLogic has rapidly developed an excellent reputation for manufacturing radiopharmaceuticals to rigorous quality standards and will deliver a key component of Telix’s supply chain strategy for TLX101-CDx in the U.S., subject to regulatory approval.”

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