Capricor Therapeutics, Inc. (CAPR) has disclosed a new risk, in the Regulation category.
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Capricor Therapeutics, Inc. faces significant post-approval regulatory challenges for its product candidates, as ongoing compliance with FDA requirements is critical. The company must adhere to stringent conditions involving labeling, packaging, and post-market surveillance, among others. Any discovery of issues by regulatory agencies post-approval, such as unanticipated adverse events or manufacturing problems, could result in severe consequences, including product withdrawal, operational restrictions, or heavy fines. Furthermore, failure to meet regulatory standards like cGMPs could lead to halted clinical trials, product seizures, or mandatory recalls, profoundly impacting Capricor’s business operations and financial standing.
Overall, Wall Street has a Strong Buy consensus rating on CAPR stock based on 3 Buys.
To learn more about Capricor Therapeutics, Inc.’s risk factors, click here.