Posts

FDA Extends Capricor’s Deramiocel Decision Date to November 22

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Capricor surges on plan to amend DMD filing after adcom setback

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Rare Disease Drugmakers Watch FDA for Renewed Focus on Therapies

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Sarepta delays Elevidys timeline amid FDA scrutiny

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FDA Committee Rejects Capricor's Duchenne Cell Therapy Amid Statistical Dispute

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FDA disputes Capricor's claims of Phase 3 success for DMD cell therapy, deramiocel

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Capricor Shares Plunge After FDA Says DMD Therapy Lacks Efficacy Ahead of Advisory Committee Meeting

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Sarepta Taps Former AbbVie and Tessera CEO Michael Severino as New CEO to Lead Duchenne Drugmaker's Turnaround

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Satellos Shares Early Adult Data for Duchenne Pill Ahead of Key Pediatric Readout

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Sensorion advances hearing loss gene therapy programs

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Servier inks up to $2.65B buyout of Edgewise's muscular dystrophy unit to boost neurology pipeline

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Capricor Sues Nippon Shinyaku and NS Pharma Over Pricing Flaw and Launch Delays for Deramiocel DMD Therapy

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Entrada's Stock Craters as DMD Data Underperform Expectations, Handing Advantage to Novartis

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Roche Launches New Phase 3 Trial for Elevidys to Address EU Rejection in DMD

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Biopharma Bites: Sarepta's Challenges with DMD Drugs Amid Full Approval Push, DMD Pipeline Advances

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Capricor Shares Rise as FDA Sets August 2026 Decision Date for Deramiocel in Duchenne Muscular Dystrophy After Prior Rejection

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Sarepta Therapeutics CEO Doug Ingram to Step Down by End of 2026 Amid Controversial Tenure

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Roche Terminates Phase 2 SHIELD DMD Study for Satralizumab in Duchenne Bone Health

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PTC Therapeutics Withdraws US NDA for Translarna in Nonsense Mutation Duchenne Muscular Dystrophy

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Sarepta Therapeutics Reports Positive Three-Year EMBARK Data for Elevidys in Duchenne Amid Past Safety Concerns

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