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Regeneron Pharmaceuticals Announces FDA Approval of Pasatru for Adults With ...

Published

19 August 2026

Topic

opportunities

Sectors

Biotech

Geography

United States

Source

Read at quiverquant.com

Verified

Fusion42 · 19 August 2026 · Fusion42 review

The FDA has approved Pasatru (garetosmab-grts) for adults with fibrodysplasia ossificans progressiva (FOP), an ultra-rare genetic disorder causing abnormal bone growth. Pasatru, a monoclonal antibody blocking Activin A, demonstrated over 90% reduction in new heterotopic ossification lesions and flare-ups in the OPTIMA Phase 3 trial.

This Wire brief sits within Fusion42's coverage of Biotech.

◆ The Wire takeaway

You have a rare disease treatment with FDA green light that can be given beyond specialised clinics, including at home. This opens access pathways and pushes you to plan for patient support and insurance navigation now.

Coverage

1 source · 19 Aug 2026

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Biotechfoprare-diseasedrug-approvalbiotechmonoclonal-antibody