KERENDIA (finerenone) is a Bayer program in chronic kidney disease associated with type 1 diabetes (new indication). The FDA approved it on Sep 16, 2026. 1 FDA decision on record below. Every date links its source.
All upcoming FDA decision dates on the 2026 PDUFA calendar
FDA approval tracked on pdufa.bio: chronic kidney disease associated with type 1 diabetes (new indication) (approved Sep 16, 2026). Earlier approvals may not be listed here; the FDA label is the full record. Sponsor: Bayer (BAYRY). Approval record: Supplemental NDA (S-011, submitted March 16, 2026, Priority Review) approved September 16, 2026: a third U.S. indication, CKD associated with type 1 diabetes, based on the Phase III FINE-ONE study. Bayer announced it on September 17, 2026. Market-cap tier at the time we tracked it: Large. We track 1 catalyst event for this program: 0 upcoming and 1 in the record. A PDUFA date is the FDA's target date to complete review of a marketing application; a readout is the sponsor's expected date for clinical trial results. What a PDUFA date is · why we do not compare trial results across drugs.
No upcoming catalyst is on our calendar for KERENDIA (finerenone); 1 FDA decision is on record below.
On Sep 16, 2026 the FDA approved the application. The decision page carries the source document and the measured share-price reaction.
In our records KERENDIA (finerenone) is FDA-approved for chronic kidney disease associated with type 1 diabetes (new indication) (approved Sep 16, 2026). Other approved uses may not be tracked here; the FDA label is the full record.
Bayer (BAYRY).
Yes. The FDA approved an application for KERENDIA (finerenone) on Sep 16, 2026; the decision page linked above carries the source.
FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.