Telix shares rise on FDA fast track designation
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More news: Telix shares rose 1.05% to $13.04 by 1:45pm AEDT, despite a weak broader market.
Earlier in the day, Telix announced that it had been granted a fast track designation for an investigational brain tumour imaging product by the US Food and Drug Administration (FDA).
Telix drug candidate gets US FDA fast track designation
The news: Telix Pharmaceuticals has been granted a fast track designation for an investigational brain tumour imaging product by the US Food and Drug Administration (FDA).
The numbers: Telix said the FDA granted a fast track designation for its investigational glioma imaging product, TLX101-CDx, which could be potentially be utilised as a diagnostic agent for gliomas or a certain type of brain tumours. Telix is also in the final stages of preparing its US new drug application for the product.
Telix shares last traded at $12.91 and in the past 12 months has increased 64%.
The context: Telix has signed an exclusive research collaboration and data license agreement with the University of California, San Francisco for joint development and commercialisation. This will enable the company to offer TLX101-CDx access as a commercial product in the US, subject to regulatory approval.
It has also selected PharmaLogic Holdings as its commercial manufacturing and pharmacy distribution partner, to supply finished unit doses of TLX101-CDx to the US market once it secures regulatory approval.
The source: ASX announcement
