Drug Profile

SGT 003

Alternative Names: SGT-003

Latest Information Update: 14 Aug 2026

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At a glance

Originator Solid Biosciences
Class Gene therapies
Mechanism of Action Dystrophin replacements; Gene transference

Orphan Drug Status

Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

Yes - Duchenne muscular dystrophy
New Molecular Entity No

Highest Development Phases

Phase III Duchenne muscular dystrophy

Most Recent Events

07 Aug 2026 Solid Biosciences plans to request a meeting with the US FDA to discuss potential accelerated approval pathways for SGT 003 in Q4 of 2026
07 Aug 2026 Updated adverse events data from the phase I/II INSPIRE DUCHENNE trial in Duchenne muscular dystrophy released by Solid Biosciences
28 Apr 2026 SGT 003 receives Orphan Drug status for Duchenne muscular dystrophy in European Union

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