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Stock impact report

CorMedix Inc. Receives FDA Feedback on Potential Label Expansion

CorMedix Inc. (CRMD) 
NASDAQ:AMEX Investor Relations: cormedix.com
Company Research Source: GlobeNewswire
BERKELEY HEIGHTS, N.J., June 18, 2024 (GLOBE NEWSWIRE) -- CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and 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 3rd 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 preve Show less Read more
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