Solid Biosciences Provides Update On SGT-001 Clinical Development Program For Duchenne Muscular Dystrophy
Solid Biosciences Inc. (SLDB)
Last solid biosciences inc. earnings: 8/14 07:25 am
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Source: GlobeNewswire
- Full Clinical Hold Letter from the FDA Received; Company to Respond in the Coming Weeks - - Manufacturing-related Partial Clinical Hold on the High Dose of SGT-001 Resolved - CAMBRIDGE, Mass., April 18, 2018 (GLOBE NEWSWIRE) -- Solid Biosciences Inc. (NASDAQ:SLDB) today announced that the Company has received a letter from the U.S. Food and Drug Administration (FDA) relating to the previously-announced full clinical hold on IGNITE DMD, the Company’s Phase I/II clinical trial for its investigational gene therapy, SGT-001, for the treatment of Duchenne muscular dystrophy (DMD). The Company plans to submit a response to this letter to the FDA in the coming weeks. The FDA also informed Solid that the Company has satisfactorily addressed manufacturing-related questions that led to the previously-announced partial clinical hold on the high dose of SGT-001 in IGNITE DMD. “We believe SGT-001 has the potential to significantly benefit patients with DMD. We are working with the FDA to be
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