Atebrioz (zilurgisertib) approved for fibrodysplasia ossificans progressiva in patients 12 and older: the FDA's notice was published September 25, 2026, the day before the Saturday September 26 PDUFA goal date.
Run-up into the decision (T-120 → T+5)
Daily close, T-120 (4/6/26) through T+0. Run-up high $128.57 on 7/8/26, low $89.32 on 9/23/26 (T-120 to T-1). FDA decision 9/25/26. Historical price action, not a forecast.
Key facts
FDA decision date2026-09-25
OutcomeApproved
Drug / candidateAtebrioz (zilurgisertib)
IndicationFibrodysplasia ossificans progressiva (FOP), adults and pediatric patients 12 years and older: reduces the volume of total new heterotopic ossification
CompanyMirum Pharmaceuticals, Inc.
Market-cap tierMid
120-day run-up (T-120→T-1)-7.1%
Cohort decision-day move (history)2.1% median (n=235)
The PDUFA goal date was Saturday, September 26, 2026, sourced to Mirum's 8-K of May 6, 2026. The FDA published its notice of the approval on Friday, September 25, 2026 (CDER News & Events, 2:46 PM ET); Mirum and Incyte announced it at 7:00 PM ET the same day. Neither document states the day the FDA acted and Drugs@FDA has not yet posted the approval letter, so the approval is recorded as no later than September 25 and no early/late margin is published until the letter posts. Atebrioz is a once-daily 100 mg oral ALK2 inhibitor, approved with Fast Track, Priority Review and Orphan Drug designations. The FDA issued a Rare Pediatric Disease Priority Review Voucher to Incyte. Incyte developed zilurgisertib and licensed it to Mirum for worldwide development and commercialization; an EU marketing authorization application is under review. Efficacy (PROGRESS Cohort 1, 63 patients): mean total new heterotopic ossification volume fell 3.2 cm3 on Atebrioz and rose 24.6 cm3 on placebo at week 24.
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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