CorMedix Inc. Receives FDA Feedback on Potential Label Expansion [Yahoo! Finance]
CorMedix Inc. (CRMD)
NASDAQ:AMEX Investor Relations:
cormedix.com
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Source: Yahoo! Finance
commercializing therapeutic products for life-threatening diseases and conditions, today announced that the U.S. Food and Drug Administration (FDA) has provided feedback to the Company's request to discuss development plans for additional indications for DefenCath. The FDA provided supportive feedback regarding the Company's plans to pursue an expanded indication in adult Total Parenteral Nutrition (TPN) patients. CorMedix expects to submit a complete clinical protocol to FDA in the 3 rd quarter with a goal of gaining further alignment and initiating the program by the end of 2024. In addition, the FDA confirmed its requirement that the Company conduct a study in pediatric hemodialysis (HD) patients under the Pediatric Research Equity Act (PREA). CorMedix intends to pursue the development of DefenCath for the expanded indication of the prevention of Central Line Associated Blood Stream Infections (CLABSI) in adult patients receiving TPN through a central venous catheter. The Company
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CRMD
News
- CorMedix Inc. (NASDAQ: CRMD) had its "buy" rating re-affirmed by analysts at Needham & Company LLC. They now have a $10.00 price target on the stock.MarketBeat
- CorMedix Inc. Receives FDA Feedback on Potential Label ExpansionGlobeNewswire
- CorMedix Inc. Announces CMS Grants Pass-Through Status to DefencathGlobeNewswire
- CorMedix announces commercial agreement with dialysis provider [Seeking Alpha]Seeking Alpha
- CorMedix Inc. Announces Commercial Agreement With Top Tier Dialysis Provider [Yahoo! Finance]Yahoo! Finance
CRMD
Earnings
- 5/9/24 - Beat
CRMD
Sec Filings
- 5/23/24 - Form EFFECT
- 5/13/24 - Form 4
- 5/9/24 - Form S-3
- CRMD's page on the SEC website