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Investing.com -- Cytosorbents Corporation (NASDAQ:CTSO) stock plunged 23.5% after the blood purification therapy company received regulatory rejections for its DrugSorb-ATR device from both the U.S. FDA and Health Canada.
The company disclosed that Health Canada issued a Notice of Refusal for its Medical (TASE:BLWV) Device License application on June 26, citing non-compliance with certain regulations. Cytosorbents plans to file a "Request for Reconsideration" by July 25 as part of the prescribed review process.
Meanwhile, the FDA has scheduled an appeal hearing for the company’s requested supervisory review of its De Novo Request. Cytosorbents expects this process to be completed by the end of August 2025.
DrugSorb-ATR is designed to reduce bleeding severity in patients undergoing coronary artery bypass grafting surgery within two days of stopping the blood thinner Brilinta. The device has received FDA Breakthrough Device designation, highlighting its potential importance in addressing an unmet medical need.
Despite the regulatory setbacks, Cytosorbents remains optimistic about eventual approval. CEO Dr. Phillip Chan stated the company believes remaining deficiencies in its submissions can be resolved through the appeal processes with both agencies.
Cytosorbents expects final regulatory decisions for DrugSorb-ATR by the end of 2025.
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