FDA Will Ask Sarepta to Halt Gene Therapy Shipments
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As mothers of children with this disease, we have wept helplessly in recent months as friends — fellow members of a club we never asked to join — said goodbye to their sons, the babies they once held in their arms, whose dreams they held in their hearts until Duchenne robbed them of working muscles or a healthy future.
Sarepta Therapeutics lays off 493 workers amid FDA probe, stock drop, and concerns over its gene therapy treatment, Elevidys.
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.
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.
The drop comes the day after the drugmaker said it would add a so-called black-box warning to its gene therapy Elevidys after two teenage boys receiving the treatment died earlier this year.
Investing.com -- Sarepta Therapeutics (NASDAQ: SRPT) stock soared 36% in after-hours trading Wednesday after the biotech company announced a major strategic restructuring plan designed to ensure long-term financial sustainability while focusing on high-impact programs.
Sarepta Therapeutics, Inc. (NASDAQ:SRPT) is one of the 10 Best Small-Cap Stocks to Buy According to Billionaires. On July 10, JPMorgan lowered its price target for Sarepta Therapeutics, Inc. (NASDAQ:SRPT) from $30 to $28 but kept an “Overweight” rating.