Solid Bio is back in business after the FDA lifts clinical hold on Duchenne MD gene therapy
Three months after the FDA dropped a clinical hold on Solid Biosciences $SLDB over safety concerns related to their gene therapy for Duchenne muscular dystrophy, the biotech is back in business. Execs said Monday morning that the hold is gone and the FDA has signed off on their response.
Solid Bio’s stock shot up 18% in early trading Monday.
The very first patient to be treated with SGT-001 experienced a serious adverse event, triggering alarm bells after investigators saw a “decrease in platelet count followed by a reduction in red blood cell count, transient renal impairment and evidence of complement activation.”
Unlock this article instantly by becoming a free subscriber.
You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.
