welcome to DuchenneXchange
- a positively charged Duchenne muscular dystrophy community.- join today!
- log in
Solid Biosciences Provides Update Regarding the IGNITE DMD Phase I/II Clinical Hold
Solid Biosciences Inc., a life sciences company focused on advancing meaningful therapies for Duchenne muscular dystrophy, today announced that it received written communication from the U.S. Food and Drug Administration (FDA) that the Company’s IGNITE DMD Phase I/II clinical trial remains on clinical hold.
In November 2019, the FDA placed IGNITE DMD on clinical hold as the result of a serious adverse event (SAE) that occurred in the sixth patient dosed in the trial; as previously reported the SAE has fully resolved. In April 2020, Solid provided the FDA with information and measures intended to improve patient safety and in May 2020, Solid received written communication from the FDA that the trial remained on hold. In June 2020, the Company submitted a response to the FDA that provided data related to manufacturing process improvements.
rareRelated
-
Clinical trial of gene therapy for Duchenne muscular dystrophy underway at University of Florida HealthScreening has resumed in a clinical tria...
-
Solid Biosciences announces FDA removes clinical hold on SGT-001Solid Biosciences Inc. today announced t...
-
Gene Therapy for Duchenne Muscular DystrophyGene Therapy for Duchenne Muscular Dyst...
-
Solid Biosciences Reports First Quarter 2019 Financial Results and Provides Business UpdateSolid Biosciences Inc. (Nasdaq: SLDB) to...
-
Preliminary Data and Intention to Dose Escalate in IGNITE DMDToday we announced our intention to move...
-
Microdystrophin Gene Transfer Study in Adolescents and Children With DMDThis is a randomized, controlled, open-l...
-
Solid Biosciences Provides SGT-001 Program UpdateCAMBRIDGE, Mass., Nov. 12, 2019 (GLOBE...
