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Policy

FDA Approves Atebrioz for Fibrodysplasia Ossificans Progressiva, a Disease Affecting About 300 Americans

Mirum will commercialize the Incyte-discovered drug for patients 12 and older. In the PROGRESS trial, new bone-lesion volume fell 3.2 cubic centimeters against a 24.6 increase on placebo.

ME

By Marcus Elrod

Sep 26, 2026 · 8 min read

The Food and Drug Administration has approved Atebrioz, or zilurgisertib, to reduce total new heterotopic ossification volume in patients aged 12 and older with fibrodysplasia ossificans progressiva, Mirum Pharmaceuticals and Incyte said in an announcement issued Friday at 7:00 p.m. Eastern.

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ME

Marcus Elrod

Marcus tracks positioning, flows and rates. He writes CI's weekly market internals column.

Marcus Elrod writes for Corporate Insider Inc.

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