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Tag: AavantiBio

Solid Biosciences Announces Receipt of European Commission Orphan Drug Designation for SGT-003 for the Treatment of Duchenne Muscular Dystrophy (Globe Newswire)

Solid Biosciences Inc., which acquired UF startup AavantiBio, announced that the European Commission has granted Orphan Drug designation to SGT-003 for treating Duchenne muscular dystrophy.

Solid Biosciences Provides Interim Positive Clinical Update on Phase 1/2 INSPIRE DUCHENNE Trial (Globe Newswire)

Solid Biosciences Inc., which acquired UF startup AavantiBio, reported updated positive interim data from the ongoing Phase 1/2 INSPIRE DUCHENNE clinical trial of SGT-003.

Solid Biosciences Announces Oversubscribed $240 Million Private Placement (Globe Newswire)

Solid Biosciences Inc., which acquired UF startup AavantiBio, announced that it has entered into a securities purchase agreement with a select group of institutional accredited investors for an approximately $240 million private placement.

Solid Biosciences Announces Positive Feedback From Type C Meeting With FDA for SGT-003 Gene Therapy for Duchenne Muscular Dystrophy (Globe Newswire)

Solid Biosciences Inc., which acquired UF startup AavantiBio, announced a positive regulatory update from its recent Type C meeting with the U.S. FDA that supports the continued advancement of SGT-003 as a potential treatment for Duchenne muscular dystrophy.

Solid Biosciences Doses First Patient in Phase 1b FALCON Trial for Friedreich’s Ataxia (Solid Biosciences)

Solid Biosciences Inc., which acquired UF startup AavantiBio, announced that the first participant has been dosed in FALCON, the Company’s Phase 1b, first-in-human clinical trial evaluating SGT-212, its investigational gene therapy for the treatment of Friedreich’s ataxia (FA).

Solid Biosciences Announces Licensing Agreement With Andelyn Biosciences for the Use of Proprietary Next-Generation Capsid AAV-SLB101 (Globe Newswire)

Solid Biosciences Inc., which acquired UF startup AavantiBio, announced a non-exclusive worldwide license and collaboration agreement with Andelyn Biosciences for the use of Solid’s proprietary, next-generation capsid, AAV-SLB101.

Solid Biosciences Awarded Innovation Passport Designation Under the New UK Innovative Licensing and Access Pathway for SGT-003 (BioSpace)

Solid Biosciences Inc., which acquired UF startup AavantiBio, announced that SGT-003, the Company’s investigational gene therapy for Duchenne muscular dystrophy (Duchenne), has been granted an Innovation Passport under the new ILAP.

Solid Biosciences Announces Licensing Agreement with Kinea Bio for the Use of Proprietary Next-Generation Capsid AAV-SLB101 (Solid Biosciences)

Solid Biosciences Inc., which acquired UF startup AavantiBio, announced a non-exclusive worldwide license and collaboration agreement with Kinea Bio for the use of Solid’s proprietary, next-generation capsid, AAV-SLB101.

Solid Biosciences Receives FDA Fast Track Designation for SGT-501 First-in-Class Gene Therapy for Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT)

Solid Biosciences Inc., which acquired UF startup AavantiBio, announced that it received Fast Track designation from the U.S. Food and Drug Administration (FDA) for SGT-501, the Company’s novel, AAV-based investigational gene therapy for the treatment of catecholaminergic polymorphic ventricular tachycardia (CPVT).

Solid Biosciences Announces FDA IND and Health Canada CTA Approval for First-in-Class Cardiac Gene Therapy To Treat Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT)

Solid Biosciences, which acquired UF startup AavantiBio, announced FDA and Health Canada approval to begin clinical trials of SGT-501, a gene therapy targeting CPVT, a severe heart rhythm disorder caused by RYR2 mutations.

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