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Mirum bags FDA approval for ultra-rare bone lesion disorder, heating up rivalry with Regeneron
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Fusion42 · 25 September 2026 · Fusion42 review
The FDA approved Mirum Pharmaceutical's oral drug Atebrioz for fibrodysplasia ossificans progressiva (FOP), an ultra-rare bone lesion disorder, expanding treatment options alongside Regeneron's recently approved Pasatru. Atebrioz targets patients aged 12 and older and offers a convenient oral alternative to Pasatru's intravenous infusion, positioning Mirum for a competitive market entry.
This Wire brief sits within Fusion42's coverage of Biotech, and 2 sources have reported it between 25 Sep 2026 and 27 Sep 2026.
◆ ◆ The Wire takeaway
You must act fast to engage FOP patients now more reachable with Mirum's oral drug opening access to younger patients. Regeneron's intravenous treatment still dominates severe cases but your faster route to patients under 12 could secure early market advantages.
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2 sources · first reported 25 Sep 2026 · latest 27 Sep 2026
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