Mirum and Incyte’s Atebrioz Wins FDA Approval for Rare Bone Disorder FOP
September 29, 2026
Source: drugdu
26
On September 25, Mirum Pharmaceuticals and Incyte announced that the U.S. FDA approved Atebrioz™ (zilurgisertib) to reduce new heterotopic ossification (HO) volume in patients aged 12 and older with fibrodysplasia ossificans progressiva (FOP).
Zilurgisertib is a once-daily oral small-molecule inhibitor of activin receptor-like kinase 2 (ALK2), directly blocking the key signaling pathway driving abnormal bone formation in soft tissue. FOP is an ultra-rare progressive genetic disorder in which soft tissue gradually ossifies, causing severe mobility impairment. The approval was based on the pivotal Phase 2 PROGRESS study. Mirum licensed worldwide rights from Incyte.
Source: https://ir.mirumpharma.com/news/news-details/2026/Mirum-Pharmaceuticals-and-Incyte-Announce-U-S--FDA-Approval-of-Atebrioz-zilurgisertib-for-Adult-and-Pediatric-Patients-with-Fibrodysplasia-Ossificans-Progressiva/default.aspx
By editor
Copyright©2026 Ddu. All rights reserved.
Read more on
- Novo Nordisk and Nanexa Ink Up to €1.165B Long-Acting Delivery Deal for Obesity and Diabetes September 29, 2026
- siRNA Biotech ADARx Raises $446M in 2026’s Third-Largest Biotech IPO September 29, 2026
- Merck and Eisai’s Welireg Plus Lenvima Approved by FDA for Previously Treated Advanced Kidney Cancer September 29, 2026
- J&J in Talks to Sell DePuy Synthes to Apollo September 29, 2026
- APAC Leadership Transition and Cyberattack Hits Full-Year Guidance September 29, 2026
your submission has already been received.
OK
Subscribe
Please enter a valid Email address！
Submit
The most relevant industry news & insight will be sent to you every two weeks.
