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Telix and FDA Align on Resubmission for TLX101-CDx with Expedited Review Expected
8:42am on Tuesday 9th of September, 2025 AEST
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Healthcare
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Telix and FDA Align on Resubmission for TLX101-CDx with Expedited Review Expected
8:42am on Tuesday 9th of September, 2025 AEST
Key Points
Agreement reached with FDA on NDA resubmission pathway for TLX101-CDx
Resubmission planned for Q4 2025 with additional confirmatory efficacy analysis
FDA indicates likely expedited review following resubmission
TLX101-CDx remains unapproved and excluded from 2025 revenue guidance
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Telix Pharmaceuticals (ASX:TLX)
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