KERENDIA (finerenone), T1D-CKD was approved by the FDA on September 16, 2026 for chronic kidney disease associated with type 1 diabetes (new indication).
KERENDIA (finerenone) approved for a third U.S. indication, chronic kidney disease associated with type 1 diabetes, on September 16, 2026 (FDA letter); Bayer announced it on September 17.
Bayer never published a PDUFA goal date for this supplemental application: its May 21, 2026 release states FDA acceptance and Priority Review only. The FDA's approval letter for NDA 215341/S-011 is dated September 16, 2026 (Drugs@FDA), which is the decision date; Bayer's release is dated September 17. Because no sponsor-stated goal date exists, no early/late margin is published for this decision. The sNDA was submitted March 16, 2026 and is based on the Phase III FINE-ONE study (242 adults; 25% reduction in UACR versus placebo over six months).
Run-up figures are the stock's own daily closing path over the 120 trading days before the decision, from our price history. Cohort move is the historical median absolute decision-day move for this market-cap tier. History, not a prediction.
Primary source: FDA approval letter, NDA 215341/S-011, September 16, 2026
FDA record of the action: the FDA approved on September 16, 2026, per NDA 215341 S-011 (FDA letter). The sponsor announced it the same day. Action dates on pdufa.bio come from the FDA's own record, not the press release. Every FDA action we hold, by FDA date: FDA approval letters.
Yes. The FDA approved the application for KERENDIA (finerenone), T1D-CKD on September 16, 2026, per the FDA's own record. The primary source is linked on this page.
KERENDIA (finerenone), T1D-CKD is a Bayer AG (BAYRY) program. The FDA decision came on September 16, 2026; the FDA's own record of the decision is linked on this page.
Measured over the 120 trading days before the decision (T-120 to T-1), BAYRY moved +27.9%. That is the recorded price path into this specific event. Historical measurement, not a prediction, and not investment advice.