Bayer (XTRA:BAYN) Wins FDA Acceptance For CKD Filing Without Diabetes

What happened: The U.S. FDA accepted Bayer's (XTRA:BAYN) supplemental New Drug Application for KERENDIA in adults with chronic kidney disease without diabetes. KERENDIA is already approved in the U.S. for CKD associated with type 2 diabetes. Key numbers: FIND CKD enrolled 1,584 patients and showed a 0.7 mL/min/1.73 m²/year difference in eGFR decline versus placebo. Why it matters: The filing leans on late stage data to extend an existing drug franchise into a population outside current U.S. approvals. Bayer's narrative treats new KERENDIA labels as a catalyst to help offset patent losses. Market: +1.2% by next close ($2.31 on Oct 12), +7.7% YTD

The U.S. FDA accepted Bayer's (XTRA:BAYN) supplemental New Drug Application for KERENDIA in adults with chronic kidney disease without diabetes. KERENDIA is already approved in the U.S. for CKD associated with type 2 diabetes.

The filing leans on late stage data to extend an existing drug franchise into a population outside current U.S. approvals. Bayer's narrative treats new KERENDIA labels as a catalyst to help offset patent losses. Market: +1.2% by next close ($2.31 on Oct 12), +7.7% YTD