SLDB News & Events

Solid Biosciences reported updated "positive" interim data from the ongoing Phase 1/2 INSPIRE DUCHENNE clinical trial of SGT-003. The new data, including additional muscle biopsy, serum biomarker, cardiac function, and safety analyses, "add to a growing dataset that suggests the potential of the biological activity of SGT-003 microdystrophin therapy," the company stated. The interim update was delivered in an oral presentation at the 2026 MDA Annual Meeting on March 11. "SGT-003 has been generally well tolerated in the 40 participants dosed as of March 11, 2026. The safety and tolerability profile observed in the INSPIRE DUCHENNE trial continued to be promising; SGT-003 is administered using a low-burden, steroid-only prophylactic immunomodulation regimen. The trial is being conducted at 15 clinical sites across the US, Canada, Italy and the United Kingdom and participant dosing remains ongoing. Microdystrophin transduction and expression levels, beta-sarcoglycan localization and nNOS activity were evaluated by biopsy in 20 participants (ages 1-10 years) at Day 90 and in 3 participants at Day 360. Results demonstrated robust mean vector copies per nucleus and microdystrophin expression as well as properly localized and restored beta-sarcoglycan-positive fibers and nNOS activity-positive fibers," the company stated. Bo Cumbo, President and CEO of Solid Biosciences commented, "These data continue to suggest that SGT-003 may be having a disease-relevant treatment effect, with observed robust microdystrophin expression, restoration of key components of the dystrophin-associated protein complex suggesting a direct biologic correlate of dystrophin activity, and improvements across multiple biomarkers of muscle integrity. Together with the promising safety and tolerability profile, these interim results reinforce our confidence in the potential of SGT-003 to meaningfully impact the disease course of Duchenne. Duchenne continues to have an unmet medical need. We are pursuing guidance on a potential accelerated approval pathway for SGT-003 and look forward to continued engagement with the FDA as we work toward that goal. Our focus remains on urgently advancing SGT-003 to provide the Duchenne community with an additional therapeutic choice."

Solid Biosciences trading halted, news pending

Solid Biosciences entered into a securities purchase agreement with a select group of institutional accredited investors for an approximately $240M private placement, before deducting placement agent fees and offering expenses, which is expected to close on or about March 9, 2026, subject to the satisfaction of customary closing conditions. The private placement is being conducted in accordance with applicable Nasdaq rules and was priced to satisfy the "Minimum Price" requirement. In the private placement, the Company is selling 14,973,257 shares of common stock at a price of $5.61 per share and, in lieu of common stock to investors who so choose, pre-funded warrants to purchase up to 27,807,482 shares of common stock at a price of $5.609 per pre-funded warrant. Each pre-funded warrant will have an exercise price of $0.001 per share, will be exercisable immediately, and will be exercisable until exercised in full.The private placement was anchored by existing and new investors, including Perceptive Advisors, Bain Capital Life Sciences, RA Capital Management, Invus, Vestal Point Capital, Janus Henderson Investors, and Deep Track Capital, among others Leerink Partners and Citigroup are acting as joint lead placement agents for the financing. Cantor is acting as co-lead placement agent for the financing. Truist and H.C. Wainwright & Co. are acting as co-placement agents for the financing.