SLDB biotech catalysts & pipeline

SOLID BIOSCIENCES INC · Data as of 2026-10-25

Upcoming catalysts

SGT-003 — FDA meeting

Q4 2026

We plan to meet with the FDA late in the fourth quarter of 2026 to discuss the INSPIRE DUCHENNE SGT-003 data package and to seek guidance on a potential accelerated approval pathway for SGT-003; we expect to provide an update as discussions progress.

Source filing

SGT-212 — Initial data

Q1 2027

The trial is expected to enroll approximately 10 non-ambulatory and ambulatory adult participants (aged 18-40) living with FA in up to three cohorts and is designed to evaluate the safety and tolerability of contemporaneous IDN and systemic IV infusion of SGT-212, with initial data anticipated in the first quarter of 2027, subject to participant enrollment.

Source filing

SGT-501 — Initial data

H1 2027

We anticipate dosing our first participant in the second half of 2026 with initial safety data anticipated in the first half of 2027, subject to participant enrollment.

Source filing

SGT-003 — Conference presentation

Oct 28

Title: SGT-003 Gene Therapy Restores DAPC Stability and Improves Muscle Integrity in Duchenne Muscular Dystrophy Scientific Session: Cardiovascular & Muscular Diseases Poster Session: Poster Session I (Uneven Posters) Poster Number: P0611 Date/Time: October 28, 13:30-15:30 CET Presenter: Peter Burch, Director, Discovery & Translational Development

Source filing

POLARIS-101™ — Conference presentation

Oct 29

Title: Successful Polaris-101™ Transduction of Multiple Tissues After Depletion of Preexisting Antibodies Using a Novel IgG-Degrading Enzyme Scientific Session: Immune Responses to Gene Therapy Poster Session: Poster Session II (Even Posters) Poster Number: P0708 Date/Time: October 29, 14:00-16:00 CET Presenter: Peter Burch, Director, Discovery & Translational Development

Source filing

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