FDA Accepts BLA for TLX250-CDx (Zircaix®) for Kidney Cancer Imaging, Grants Priority Review
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The FDA has accepted Telix Pharmaceuticals' BLA for TLX250-CDx, a kidney cancer imaging agent, and granted it Priority Review, with a PDUFA date set for August 27, 2025. This development could lead to a U.S. commercial launch in 2025.
February 26, 2025 | 12:00 am
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Telix Pharmaceuticals' TLX250-CDx has received FDA Priority Review, indicating a potential U.S. launch in 2025. This is a significant regulatory milestone for the company.
The FDA's acceptance of the BLA and granting of Priority Review for TLX250-CDx is a major regulatory milestone, suggesting a high likelihood of approval and subsequent U.S. market entry. This could significantly boost Telix's market presence and revenue potential.
CONFIDENCE 95
IMPORTANCE 90
RELEVANCE 100