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Sarepta LGMD trials all hit by FDA hold amid newly surfaced safety concerns over gene therapy
The Sarepta saga continues, with the FDA slapping a clinical hold across all of the company’s investigational limb girdle muscular dystrophy (LGMD) trials, while also revoking the biopharma’s gene therapy platform technology designation.
Pharmaceutical Technology on MSN9h
Sarepta halts Elevidys shipments following FDA pressureSarepta CEO Doug Ingram said it is important the company maintains a “positive working relationship” with the FDA.
Most investors don’t see the drugmaker’s executive management as credible, following the failure to disclose a patient death, ...
Sarepta officials said the temporary halt in shipments was done to maintain a productive working relationship with regulators ...
Sarepta Therapeutics said it will voluntarily “and temporarily” pause all shipments of Elevidys® (delandistrogene ...
On an investor call Friday, analysts grilled the company over its apparent lack of transparency on the matter.
FDA places clinical hold on Sarepta's LGMD gene therapy trials after three deaths and revokes platform tech designation due ...
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