ELEVIDYS – Talk Bio

FDA OKs Sarepta Study of New Immune Suppression Approach with Elevidys; Gilead Acquires Preclinical TREX1 Program

2 weeks ago talkbio0Tagged acute liver injury, ELEVIDYS, gene therapy, Gilead, Muscular Dystrophy, Duchenne, sirolimus, Therapeutic immunosuppression, TREX1 gene, United States Food and Drug Administration

FDA; Sarepta; Elevidys; immunosuppression; Duchenne muscular dystrophy; Gilead; TREX1; gene therapy; sirolimus; acute liver injury

FDA Imposes Boxed Warning and Restricts Use of Sarepta’s Elevidys Gene Therapy for Duchenne Muscular Dystrophy

3 weeks ago talkbio0Tagged Black Box Warning, ELEVIDYS, gene therapy, Indication restriction, Liver Failure, Acute, Muscular Dystrophy, Duchenne, Post-marketing study, Safety labeling, United States Food and Drug Administration

Elevidys; Sarepta Therapeutics; Duchenne muscular dystrophy; FDA; Boxed warning; Gene therapy; Acute liver failure; Safety labeling; Indication restriction; Post-marketing study

Sarepta’s Duchenne Muscular Dystrophy Drugs Fail Confirmatory Trial, Company Pursues Full FDA Approval Regardless

1 month ago talkbio0Tagged Accelerated, AMONDYS, Approved, Clinical trial failure, Confirmatory Trial, ELEVIDYS, Muscular Dystrophy, Duchenne, Statistical Significance, United States Food and Drug Administration

Sarepta Therapeutics; Duchenne muscular dystrophy; confirmatory trial; AMONDYS 45; VYONDYS 53; Elevidys; FDA approval; clinical trial failure; accelerated approval; statistical significance

Sarepta Extends $700M Debt to 2030, Adds Private Placement Amid Elevidys Uncertainty

4 months ago talkbio0Tagged Biopharma, convertible, debt maturity extension, ELEVIDYS, financial strategy, Note (document), private placement

Sarepta Therapeutics; debt maturity extension; convertible notes; private placement; Elevidys; financial strategy; biopharma

Elevidys Sales Surge in Sarepta Q2 2025 Despite Safety Concerns

4 months ago talkbio0Tagged ELEVIDYS, gene therapy, Pauses, Performance, Safety Issues, Sales - occupational activity, United States Food and Drug Administration

Sarepta Therapeutics; Elevidys; Q2 2025; gene therapy; sales performance; FDA; safety issues; shipment pause

Sarepta Pursues Efficiency Measures Amid $1 Billion Debt Due in 2027

4 months ago talkbio0Tagged 2025, debt, decline, Efficiency, ELEVIDYS, Financial cost, financial results, Financial savings, Measures, Muscular Dystrophy, Duchenne, restructuring, United States Food and Drug Administration

Sarepta Therapeutics; debt 2027; efficiency measures; ELEVIDYS; cost savings; restructuring; financial results 2025; FDA; Duchenne muscular dystrophy; stock decline

Untangling Sarepta’s Gene Therapy Fallout and Trust Deficit

4 months ago talkbio0Tagged AAVrh74 vector, clinical holds, ELEVIDYS, gene therapy, Muscular Dystrophies, Limb-Girdle, Muscular Dystrophy, Duchenne, patient deaths, Regulatory Action, United States Food and Drug Administration

Sarepta Therapeutics; gene therapy; Elevidys; Duchenne muscular dystrophy; limb-girdle muscular dystrophy; patient deaths; FDA; AAVrh74 vector; regulatory action; clinical holds; transparency