drug
delandistrogene moxeparvovec
Marketedupdated 3mo agoby $SRPT Sarepta Therapeutics, Inc.
Approvedcommunity read0 votes
indications
investigational
Duchenne Muscular Dystrophy
all catalysts(0)
nothing on the calendar yet
Trials studying delandistrogene moxeparvovec
- —An Observational Study Comparing Delandistrogene Moxeparvovec (ELEVIDYS) With Standard of Care in Participants With Duchenne Muscular Dystrophy
- phase4Study to Evaluate the Safety and Effectiveness of ELEVIDYS in Participants With Duchenne Muscular Dystrophy Treated in a Post-Marketing Setting
- phase1A Gene Transfer Therapy Study to Evaluate the Safety of and Expression From Delandistrogene Moxeparvovec (SRP-9001) in Participants With Duchenne Muscular Dystrophy (DMD)
- phase2A Gene Delivery Study to Evaluate the Safety and Expression of Delandistrogene Moxeparvovec in Participants Under the Age of Four With Duchenne Muscular Dystrophy (DMD)
- phase3A Long-term Follow-up Study of Participants Who Received Delandistrogene Moxeparvovec (SRP-9001) in a Previous Clinical Study
- phase1A Gene Transfer Therapy Study to Evaluate the Safety and Efficacy of Delandistrogene Moxeparvovec (SRP-9001) Following Imlifidase Infusion in Participants With Duchenne Muscular Dystrophy (DMD) Determined to Have Pre-existing Antibodies to Recombinant Adeno-Associated Virus Serotype (rAAVrh74)
- phase1A Gene Transfer Therapy to Evaluate the Safety and Efficacy of Delandistrogene Moxeparvovec (SRP-9001) Following Therapeutic Plasma Exchange (Plasmapheresis) in Participants With Duchenne Muscular Dystrophy (DMD) and Pre-existing Antibodies to AAVrh74
- phase3A Gene Transfer Therapy Study to Evaluate the Safety and Efficacy of Delandistrogene Moxeparvovec (SRP-9001) in Participants With Duchenne Muscular Dystrophy (DMD)
News(10)
- Sarepta pushes back Elevidys timeline; Emergent lays off 90 staffers🗓️ Sarepta Therapeutics delays readout of non-ambulatory Elevidys study: The company previously said the study would read out by year end, but reported in its Wednesday earnings that 12-week data areendpoints · 1h ago
- Capricor CEO won’t rule out legal action against FDA after negative adcommAfter an FDA advisory committee voted 9-3 on Wednesday against recommending Capricor Therapeutics’ Duchenne muscular dystrophy cardiomyopathy drug for approval, stakeholders allege an “ulterior mot…biospace · 5d ago
- Sarepta names former AbbVie R&D exec Michael Severino as next CEOAfter leaving Tessera Therapeutics earlier this month, Michael Severino will take over Sarepta Therapeutics as the biotech awaits two key regulatory decisions in Duchenne muscular dystrophy.biospace · 10d ago
- Sarepta, in search of a turnaround, taps ex-AbbVie exec Severino as CEOMost recently the leader of buzzy startup Tessera Therapeutics, Severino will look to improve the fortunes of a company facing emerging competition and declining sales for its prized gene therapy E…biopharma_dive · 10d ago
- FDA has recommitted to adcomms—but to what end?The FDA will hold advisory committee meetings this week for previously rejected investigational therapies from Replimune and Capricor Therapeutics. Some industry leaders were surprised the meetings…biospace · 10d ago
- Dyne gets early 2027 decision date for Duchenne therapy, analysts expect ‘smooth’ reviewIf approved, Dyne Therapeutics’ zeleciment rostudirsen could “capture the majority” of the exon-51 Duchenne muscular dystrophy market, given its better efficacy and dosing profile versus Sarepta Th…biospace · 16d ago
- 10 clinical trials to watch in the second half of 2026The biotechnology sector’s upswing accelerated in the first half. Positive results from anticipated trials in lung cancer, Alzheimer’s and multiple autoimmune conditions could add to the momentum.biopharma_dive · 1mo ago
- Pfizer CFO to step down; Denali sells a regulatory fast-passA search is underway for a successor to Dave Denton, who took a job outside the pharmaceutical industry. Elsewhere, a new kind of Duchenne gene therapy got venture backing and a GSK deal paid divid…biopharma_dive · 1mo ago
- With new data, Regenxbio to seek FDA approval of Duchenne gene therapyThough two serious side effects muddied the results, CEO Curran Simpson expressed optimism about a clearance and claimed FDA leadership will have a “mandate on rare disease flexibility.”biopharma_dive · 2mo ago
- STAT+: Regenxbio says Duchenne gene therapy succeeded in clinical trial, paving way for FDA submissionRegenxbio said its experimental gene therapy for Duchenne muscular dystrophy succeeded in a trial, paving the way for a submission to the FDA.stat · 2mo ago
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