Telix's TLX250-CDx BLA Faces FDA Hurdle; Resubmission Planned in 90 Days
FDA finds issue in Telix's TLX250-CDx BLA; resubmission in 90 days, no impact on 2024 finances.
The FDA found a sterility assurance filing problem in Telix Pharmaceuticals Ltd.'s BLA for the kidney cancer imaging agent TLX250-CDx, which has to be fixed, the company reported. The business anticipates responding to the FDA's concerns and resubmitting in ninety days, with no effect on the year's financial projections. Telix reiterates its commitment to granting access to this potentially groundbreaking non-invasive diagnostic tool for kidney cancer, expressing confidence in the product's commercial introduction in 2025.
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