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Steba Biotech receives FDA Orphan Drug Designation for Padeliporfin ImPACT in Upper Tract .
Steba biotechMarch 8, 2021 GMT
Designation confers advantages including marketing exclusivity and tax credits
Padeliporfin ImPACT pivotal Phase 3 trial in UTUC to start end Q1 2021
LUXEMBOURG, March 08, 2021 (GLOBE NEWSWIRE) Steba Biotech, the IMmune Photo Activate Cancer Treatment (IMPACT) specialist today announces the U.S. Food and Drug Administration granted Orphan Drug Designation (ODD) to Padeliporfin ImPACT for the treatment of adult patients with Upper Tract Urothelial Cancer (UTUC).
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The FDA has already given the green light to the Investigational New Drug (IND) application, allowing initiation of the pivotal Phase 3 clinical trial of Padeliporfin ImPACT in patients with low-grade UTUC, which is expected to begin enrollment later this month. Padeliporfin ImPACT has