FDA to Ask Sarepta to Halt Elevidys Shipments
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Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today issued the following statement:
The FDA will request Sarepta Therapeutics stop all shipments of Elevidys, its gene therapy for Duchenne muscular dystrophy, following two deaths tied to the product.
Massachusetts-based Sarepta Therapeutics, facing scrutiny from regulators, is reducing its global workforce by 36% in an effort to cut annual operating costs by hundreds of millions of dollars.
The restructuring enacted by Sarepta Therapeutics is expected to save up to $400 million in annual costs. Read why I'm downgrading SRPT stock from Hold to Sell.
Shares of Sarepta Therapeutics (NASDAQ: SRPT) plunged 26.85% in Friday pre-market after a clinical trial participant died following treatment with a gene therapy, marking the third death linked to the company's experimental treatments.
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Following the death of two teenage patients with Duchenne muscular dystrophy following Elevidys treatment, Sarepta Therapeutics adds a black box warning to the gene therapy for acute liver injury and failure and parts with more than a third of employees.
Sarepta Therapeutics, Inc. faces setbacks with Elevidys, safety issues, and workforce cuts, raising concerns about its outlook. Click for my SRPT stock update.