11:58 AM EST - Resverlogix Corp. : Announced that the U.S. Food & Drug Administration (FDA) has accepted its BETonMACE2 clinical plan as a registration enabling study with positive implications for Resverlogix and its ongoing partnership discussions. Key written development points from a recent meeting with the FDA include the following: Filing of a New Drug Application (NDA) with the FDA is possible following unequivocal efficacy at an interim analysis of BETonMACE2. All or most BETonMACE2 patients to receive top standard of care, including maximized use of SGLT2 inhibitors (SGLT2i). BETonMACE2 to increase enrichment of chronic kidney disease (CKD) patients, potentially including those with lower baseline renal function. Resverlogix Corp.
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