FDA Grants Orphan Drug Designation for TLX102

Melbourne (Australia) – 31st August 2020. Telix announces the FDA has granted ODD for 4-[²¹¹At] astato-l-phenylalanine for the treatment of multiple myeloma.

Telix Pharmaceuticals Limited is delighted to announce that the United States Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for 4-[²¹¹At] astato-l-phenylalanine (internally designated as TLX102), for the treatment of multiple myeloma.

The granting of an ODD for TLX102 qualifies Telix for various drug development incentives which may include FDA-administered market exclusivity for seven years, waived FDA prescription drug user fees, and tax credits for R&D and clinical development costs.

This internally-directed R&D program is the result of two years of collaboration with the University of Nantes and the ARRONAX cyclotron facility (France) and Osaka University (Japan) and has resulted in the in-licensing of significant new intellectual property to further augment Telix’s potential future product development pipeline.

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