Sarepta Gene Therapy Scrutiny

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Sarepta Shares Fall

Sarepta fails to win EU backing for muscle disorder gene therapy

Sarepta Therapeutics failed to win the European drug regulator's backing for its muscle disorder gene therapy on Friday, as the company faces intense regulatory scrutiny after two recent patient deaths tied to the treatment.

Bloomberg on MSN · 2d

Sarepta Shares Fall After EU Regulator Rejects Gene Therapy

Sarepta Therapeutics Inc. shares plunged after European regulators rejected its gene therapy Elevidys, intensifying scrutiny on the drugmaker after it was pressured to halt shipments of its treatment in the US.

EconoTimes · 1d

FDA Probes Death of 8-Year-Old Linked to Sarepta’s Elevidys Gene Therapy

The U.S. Food and Drug Administration (FDA) is investigating the death of an eight-year-old boy who received Sarepta Therapeutics (NASDAQ: SRPT) gene therapy, Elevidys, for Duchenne muscular dystrophy (DMD).

STAT2d

Europe moves to reject embattled Duchenne muscular dystrophy gene therapy

European regulators said that a Duchenne gene therapy should not be approved, imperiling the treatment that is also facing ...

Fierce Biotech9d

UPDATED: Analysts demand transparency after Sarepta's roundabout disclosure of 3rd patient death

On an investor call Friday, analysts grilled the company over its apparent lack of transparency on the matter.

Hoodline7d

Sarepta Therapeutics Announces Layoff of 493 Employees, Including 80 in Ohio, Amid FDA Scrutiny and Stock Decline

Sarepta Therapeutics lays off 493 workers amid FDA probe, stock drop, and concerns over its gene therapy treatment, Elevidys.

6hon MSN

Notable healthcare headlines for the week: Pfizer, UnitedHealth, Sarepta and Thermo Fisher in focus

Currently, a multidistrict litigation against Pfizer (NYSE: PFE) is underway on behalf of women who claim to have developed meningiomas after receiving four or more consecutive injections of ...

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