Citius Pharmaceuticals Aktie

Citius Pharmaceuticals für 0 Euro bei ZERO ordern (zzgl. Spreads)

WKN DE: A2DXS0 / ISIN: US17322U2078

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25.11.2024 17:16:35

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.

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