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FDA Probes Death Of 8-Year-Old Who Received Sarepta's Elevidys
The U.S. Food and Drug Administration (FDA) announced on Friday, after market close, that it is investigating the death of an 8-year-old boy who had received Elevidys, Sarepta Therapeutics Inc.’s (NASDAQ:SRPT) gene therapy for Duchenne muscular dystrophy.
Stock of Sarepta Therapeutics Inc. (NASDAQ: SRPT) surged 38.89% in Tuesday pre-market following the U.S. Food and Drug ...
This regulatory relief, combined with several other compelling catalysts, creates a pathway for the stock to potentially ...
While Sarepta has now consented to the FDA’s request to stop selling Elevidys, the company’s brief standoff with the agency ...
The ground shook for Sarepta Therapeutics, Inc. (NASDAQ:SRPT) last week as the U.S. Food and Drug Administration (FDA), ...
Sarepta's ELEVIDYS faces a critical FDA decision; an expanded label could significantly widen market reach, targeting all DMD patients. Strong Q3 performance with impressive revenue and EPS ...
The European Medicines Agency determined testing failed to prove Elevidys’ benefit and issued a negative opinion that could ...
Sarepta Therapeutics Inc. (NASDAQ:SRPT) stock declined 13% Friday after European regulators recommended against approving Elevidys, the company’s gene therapy for Duchenne muscular dystrophy.
Sarepta agrees to FDA's black box warning and announces major restructuring, including job cuts and cost-saving measures to ...
– FDA grants accelerated approval to ELEVIDYS for non-ambulatory Duchenne patients – Sarepta will host an investor conference call on June 21, 2024, at 8:30 a.m. ET ...
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