Solid Biosciences’ DMD Gene Therapy Shows Promising Early Results, Driving Stock Surge
Solid Biosciences reported positive initial data from its Phase I/II INSPIRE DUCHENNE trial evaluating SGT-003, a gene therapy candidate for Duchenne muscular dystrophy (DMD)12.
The first three patients in the trial showed an average microdystrophin expression of 110% normal as measured by western blot, with significant improvements in multiple muscle health biomarkers2.
Solid Biosciences' stock soared by 78.66% following the announcement, from $4.03 on February 14 to a high of $7.20 on February 18, 20251.
SGT-003 was well-tolerated in the first six patients dosed, with no serious adverse events observed2.
The company plans to request a meeting with the FDA in mid-2025 to discuss the potential for an accelerated approval regulatory pathway for SGT-00312.
Solid Biosciences expects to dose approximately 20 total participants in the INSPIRE DUCHENNE trial by Q4 20252.
The company recently announced an underwritten offering of common stock and pre-funded warrants, expecting to raise approximately $200 million in gross proceeds3.
Sources:
1. https://www.clinicaltrialsarena.com/news/solid-biosciences-stock-soars-on-early-success-in-dmd-gene-therapy-trial/
2. https://www.parentprojectmd.org/solid-biosciences-shares-initial-data-from-inspire-duchenne-study-of-gene-therapy-candidate-sgt-003/
3. https://marketchameleon.com/articles/b/2025/2/18/solid-biosciences-stock-surge-underwritten-offering