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ImPact Biotech Announces Completion of Treatment in Phase 3 ENLIGHTED Trial of ...
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Fusion42 · 9 September 2026 · Fusion42 review
ImPact Biotech completed treatment of 91 patients in its Phase 3 ENLIGHTED trial evaluating Padeliporfin VTP for low-grade upper tract urothelial carcinoma (LG-UTUC). The FDA provided positive feedback supporting the clinical meaningfulness of the therapy and a streamlined NDA submission pathway in 2027, while discussions on an expanded access program are ongoing.
This Wire brief sits within Fusion42's coverage of Biotech, and 2 sources have reported it.
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You can prepare to engage early with regulators and healthcare providers now that the FDA signals a supportive path for Padeliporfin in treating a rare carcinoma. This opens a new niche for minimally invasive oncology therapies where few options exist.
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2 sources · 9 Sep 2026
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