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ImPact Biotech Announces Completion of Treatment in Phase 3 ENLIGHTED Trial of ...
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Fusion42 · 10 September 2026 · Fusion42 review
ImPact Biotech has completed treatment of all patients in its Phase 3 ENLIGHTED trial for Padeliporfin VTP in low-grade upper tract urothelial carcinoma (LG-UTUC) and received positive FDA feedback supporting an NDA submission in 2027. Discussions are ongoing with the FDA about an expanded access program to enable patient access before approval.
This Wire brief sits within Fusion42's coverage of Biotech, and 2 sources have reported it.
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You gain a clearer path to market with FDA support for your LG-UTUC treatment’s NDA submission and a possible early access route via an expanded access program. You should focus on preparing for regulatory submission and engage clinicians to leverage upcoming trial data.
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2 sources · 9 Sep 2026
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