The FDA approved Atebrioz (zilurgisertib) on Sep 25, 2026. It is an Incyte Corp, Mirum Pharmaceuticals, Inc. program in fibrodysplasia ossificans progressiva (FOP), adults and pediatric patients 12 years and older: reduces the volume of total new heterotopic ossification. 2 FDA decisions on record below. Every date links its source.
INCY catalyst hub · MIRM catalyst hub
All upcoming FDA decision dates on the 2026 PDUFA calendar
FDA approval tracked on pdufa.bio: fibrodysplasia ossificans progressiva (FOP), adults and pediatric patients 12 years and older: reduces the volume of total new heterotopic ossification (approved Sep 25, 2026). Earlier approvals may not be listed here; the FDA label is the full record. Sponsor: Incyte Corp, Mirum Pharmaceuticals, Inc. (INCY, MIRM). Approval record: NDA approved with Fast Track, Priority Review and Orphan Drug designations (FDA notice). 100 mg orally once daily. 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 HO volume -3.2 cm3 on Atebrioz vs +24.6 cm3 on placebo at week 24. Market-cap tier at the time we tracked it: Large. We track 2 catalyst events for this program: 0 upcoming and 2 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.
| Fund | Shares | Value at quarter end | Filing |
|---|---|---|---|
| Baker Bros. Advisors | 30,762,330 | $3.49 billion | filed August 14, 2026 |
13F reports list long positions in common stock at quarter end, are due 45 days later, and show no short positions or later trades. Notes, warrants and other instruments are not counted as shares.
| Fund | Shares | Value at quarter end | Filing |
|---|---|---|---|
| BVF Inc. | 1,056,027 | $123.6 million | filed August 14, 2026 |
| Baker Bros. Advisors | 445,975 | $52.2 million | filed August 14, 2026 |
| RA Capital Management | 318,554 | $37.3 million | filed August 14, 2026 |
| Perceptive Advisors | 115,391 | $13.5 million | filed August 14, 2026 |
13F reports list long positions in common stock at quarter end, are due 45 days later, and show no short positions or later trades. Notes, warrants and other instruments are not counted as shares.
No upcoming catalyst is on our calendar for Atebrioz (zilurgisertib); 2 FDA decisions are on record below.
On Sep 25, 2026 the FDA approved the application. The decision page carries the source document and the measured share-price reaction.
In our records Atebrioz (zilurgisertib) is FDA-approved for fibrodysplasia ossificans progressiva (FOP), adults and pediatric patients 12 years and older: reduces the volume of total new heterotopic ossification (approved Sep 25, 2026). Other approved uses may not be tracked here; the FDA label is the full record.
Incyte Corp, Mirum Pharmaceuticals, Inc. (INCY, MIRM).
Yes. The FDA approved an application for Atebrioz (zilurgisertib) on Sep 25, 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.