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Guard Therapeutics granted FDA Fast Track designation for RMC-035
Guard Therapeutics announced that the U.S. Food and Drug Administration (FDA) granted RMC-035 (ROSgard) Fast Track designation for reducing the risk of an irreversible loss of kidney function, initiation of kidney replacement therapy or death following open-chest cardiac surgery in patients who are at increased risk for acute kidney injury.
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Guard Therapeutics receives IND approval from the FDA for RMC-035
Guard Therapeutics announced that the U.S. Food and Drug Administration (FDA) granted the company's Investigational New Drug (IND) application for the investigational drug RMC-035 (ROSgard). The approval enables expansion of the clinical development program for RMC-035 to the US, including the ongoing global and placebo-controlled Phase 2 study AKITA in cardiac surgery.
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First kidney transplant recipient dosed with Guard Therapeutics' investigational drug RMC-035
Guard Therapeutics today announces that the first patient has been dosed in a Phase 1b clinical trial of the investigational drug RMC-035 (ROSgard) in kidney transplantation. The company has thus achieved an important milestone by expanding the clinical development program to a second indication where RMC-035 has the potential to protect against acute kidney injuries. Full study results are expected to be available in the first half of 2023.
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