Citius Pharmaceuticals Reports Productive FDA Type C Meeting to Discuss Phase 3 Mino-Lok® Program and Pathway to Approval [Yahoo! Finance]
Citius Pharmaceuticals, Inc. (CTXR)
NASDAQ:AMEX Investor Relations:
ir.citiuspharma.com
Company Research
Source: Yahoo! Finance
company dedicated to the development and commercialization of first-in-class critical care products, today announced that the Company 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 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. The meeting encompassed an extensive range of topics critical to the NDA process, including in-vitro, clinical efficacy an
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News
- Market Sentiment Around Loss-Making Citius Pharmaceuticals, Inc. (NASDAQ:CTXR) [Yahoo! Finance]Yahoo! Finance
- Citius Pharmaceuticals, Inc. (NASDAQ: CTXR) had its "hold" rating re-affirmed by analysts at D. Boral Capital.MarketBeat
- Citius Pharmaceuticals Reports Productive FDA Type C Meeting to Discuss Phase 3 Mino-Lok® Program and Pathway to ApprovalPR Newswire
- Citius Pharmaceuticals, Inc. Announces 1-for-25 Reverse Stock Split [Yahoo! Finance]Yahoo! Finance
- Citius Pharmaceuticals, Inc. Announces 1-for-25 Reverse Stock SplitPR Newswire
CTXR
Earnings
- 8/12/24 - Miss
CTXR
Analyst Actions
- 11/12/24 - HC Wainwright
CTXR
Sec Filings
- 12/20/24 - Form 8-K
- 11/27/24 - Form SC
- 11/26/24 - Form 8-K
- CTXR's page on the SEC website