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.
Run-up into the decision (T-120 → T+5)
Daily close, T-120 (3/25/26) through T+4. Run-up high $15.19 on 7/2/26, low $9.88 on 6/2/26 (T-120 to T-1). FDA decision 9/16/26. Historical price action, not a forecast.
Key facts
FDA decision date2026-09-16
OutcomeApproved
Drug / candidateKERENDIA (finerenone), T1D-CKD
IndicationChronic kidney disease associated with type 1 diabetes: new indication to reduce urinary albumin-to-creatinine ratio (FINE-ONE)
CompanyBayer AG
Market-cap tierLarge
120-day run-up (T-120→T-1)+27.9%
Cohort decision-day move (history)1.0% median (n=835)
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.
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