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

(RTTNews) - Shares of Citius Pharmaceuticals (CTXR) gained nearly 5% on Monday after the company announced it held a constructive in-person Type C meeting with the U.S. Food and Drug Administration (FDA).

The meeting followed successful completion of the company's pivotal Phase 3 clinical trial of Mino-Lok, a novel catheter lock solution designed to salvage central venous catheters in patients suffering from central line-associated bloodstream infections (CLABSI) or catheter-related bloodstream infections (CRBSI).

The primary discussion centered on responses to the FDA's questions related to Mino-Lok's clinical trial data and a pathway to a future submission.

The company said that the FDA provided clear, constructive, and actionable guidance during the discussion, underscoring a pathway to support a future New Drug Application (NDA) submission for Mino-Lok.