Weekly Digest - 06-12 May 2023

Weekly Digest - 06-12 May 2023

May 09, 2023: Seclidemstat (Oral) / Ewing sarcoma / Salarius Pharmaceuticals: The clinical hold on the Phase 1/2 trial has been lifted by the FDA

  • FDA removed the partial clinical hold on Salarius’ Phase 1/2 Ewing sarcoma trial evaluating Seclidemstat (LSD1 inhibitor)

  • FDA previously granted Seclidemstat Fast Track Designation, Orphan Drug Designation, and Rare Pediatric Disease Designation for Ewing sarcoma

  • The FDA’s decision to remove the clinical hold puts us back on track to engage in dialogue with the FDA on various topics relating to further clinical development of Seclidemstat and possible registration pathways. As we gain clarity in those discussions, we intend to provide updates to our investors,” said David Arthur, president, and chief executive officer of Salarius

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