FX.co ★ Citius Pharma Held Productive FDA Meeting To Discuss Phase 3 Mino-Lok Program, Pathway To Approval

Citius Pharmaceuticals (CTXR) saw an impressive nearly 5% increase in its shares on Monday, following the announcement of a productive in-person Type C meeting with the U.S. Food and Drug Administration (FDA). This meeting was held after the successful conclusion of their pivotal Phase 3 clinical trial for Mino-Lok, an innovative catheter lock solution aimed at preserving central venous catheters in patients affected by central line-associated bloodstream infections (CLABSI) or catheter-related bloodstream infections (CRBSI). The main focus of the meeting was to address the FDA's inquiries regarding the clinical trial data for Mino-Lok and discuss the route towards a future submission. Citius Pharmaceuticals reported that the FDA offered clear, constructive, and actionable recommendations, highlighting a pathway that supports a future New Drug Application (NDA) submission for Mino-Lok.