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Solid Biosciences outlines FDA milestones and cash runway at H.C. Wainwright conference

CEO Beau Campbell said the company has $380 million cash, runway to mid‑2028, and upcoming FDA meetings for its DMD and Friedreich’s ataxia gene‑therapy programs.

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Helena Vásquez · Business Desk · 14 Sept 2026 · 20:15 · 2 min de lecture
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Solid Biosciences outlines FDA milestones and cash runway at H.C. Wainwright conference

Solid Biosciences (SLDB) presented at the H.C. Wainwright 28th Annual Global Investment Conference on September 14, 2026. The company’s stock traded at $8.95, up $0.25 or 2.87%, and has delivered a 61% total return over the past year. With a market capitalization of $955 million, the firm reported a cash balance of roughly $380 million, giving it a runway into the first half of 2028 to fund planned FDA interactions and trial activity for its lead programs. The balance sheet shows a current ratio of 13.82 and a debt‑to‑equity of 0.05, indicating minimal leverage. Nine analysts revised earnings estimates upward following the briefing.

For the DMD gene‑therapy candidate SGT‑003, 53 boys are enrolled in the Phase III trial, which is double‑blind and placebo‑controlled. The primary endpoint is time to rise at 18 months, with stride velocity measured by wearable ankle bracelets as a secondary endpoint. The capsid platform features about 60 RGD peptides per capsid, delivering 3‑5 times greater muscle biodistribution than AAV9 in pre‑clinical models and roughly 19‑fold higher expression in human cardiomyocytes. The steroid regimen starts at 0.75 mg/kg per day, increases for 30 days post‑dose, and tapers back by day 60.

The Friedreich’s ataxia program SGT‑212 has dosed three patients, with three additional candidates screened out due to severe cardiac disease. Dosing of the fourth patient is planned for September 2026 and the fifth for October 2026, aiming for seven patients dosed by year‑end 2026. The dual‑route approach combines MRI‑guided intrathecal delivery to the cerebellar dentate nucleus with an intravenous dose of 1 × 10¹² vg/kg within 24 hours. Early data are expected in Q1 2027, including 90‑day mFARS efficacy readouts.

Regulatory timelines include an FDA Phase III guidance meeting held in late 2025/early 2026 and a follow‑up in March/April 2026 for SGT‑003. A further FDA meeting is slated for late Q4 2026 to discuss accelerated approval pathways. For SGT‑212, the next FDA interaction is projected for the first half of 2027, with a goal to launch a registrational trial by the end of that year.

Cet article a été produit avec l'assistance de l'IA et édité par un journaliste de Finance Review Daily.
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Helena Vásquez
Business Desk

Helena covers corporate news for listed and private companies across Europe, from strategy shifts to leadership changes, with an eye for what a story signals about the broader market.

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Solid Biosciences outlines FDA milestones and cash runway at H.C. Wainwright conference · Finance Review Daily