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aBLA Filing Intelligence & Biosimilar Opportunity

Pasatru

Garetosmab-grts
Anti-Activin A Monoclonal Antibody
Intravenous Injectable

For people living with fibrodysplasia ossificans progressiva (FOP), the body gradually forms bone in places where bone should not exist. This can severely restrict movement and progressively affect everyday life.

Pasatru (garetosmab-grts) is designed to help address this process by reducing new heterotopic bone formation and disease flare-ups in adults with FOP. Its approval provides another treatment option for a condition where therapeutic choices have historically been extremely limited.

As a treatment in the rare disease space, Pasatru will be important to monitor for its availability, adoption, and future relevance in clinical development.

Approval Date
19-Aug-26
Data Exclusivity Expiry
19-Aug-30
Market Exclusivity Expiry
19-Aug-38
Commercial snapshot

Market performance & projections

Revenue ($M)
NA
CAGR (%)
NA
Projected sales, 2026–2032 ($M)
Analyst projection, $M per year
2026
NA
2027
NA
2028
NA
2029
NA
2030
NA
2031
NA
2032
NA
Molecule profile

Details & specifications

Molecule
Garetosmab-grts
Innovator
REGENERON PHARMACEUTICALS, INC
Dosage Form
Intravenous Injectable
Strength
300 mg/5 mL
Therapeutic Category
Anti-Activin A Monoclonal Antibody
Usage
To reduce new heterotopic ossification and clinician-assessed disease flare-ups in adults with fibrodysplasia ossificans progressiva
Good to know

Frequently asked questions

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