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With Back-To-Back FDA Holds, Solid Hopes To Regain Footing For Duchenne Candidate

 
• By Joseph Haas

The US FDA wants more information on the first patient given SGT-001, who was hospitalized with a reduced platelet count after dosing. Solid says the patient is doing well and hopes to reply to the FDA's concerns within weeks.

Yellow road sign with a blue sky and white clouds: clinical trial

Solid Biosciences Inc.'s holding pattern, ongoing since its $125m initial public offering in January, continues – but the company hopes it can get its gene therapy candidate for Duchenne muscular dystrophy back on track now that it has received a letter from US FDA clarifying the reasons for a full clinical hold of its Phase I/II trial.

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