Solid Biosciences Gains FDA Clearance for New Drug Application

Dow Jones
08 Jan

By Katherine Hamilton

Solid Biosciences received clearance from the Food and Drug Administration for an investigational new drug application, the company said Tuesday.

The application is for SGT-212, designed to treat the degenerative disease Friedreich's ataxia. The drug is unique because it uses two routes of administration to address the illness in the cardiac region and the cerebellum.

The Charlestown, Mass.-based company expects to initiate a phase 1b clinical trial in the second half of 2025.

Shares climbed 20% to $4.70 in after-hours trading following the news.

Write to Katherine Hamilton at katherine.hamilton@wsj.com

 

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January 07, 2025 16:40 ET (21:40 GMT)

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