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Sarepta Therapeutics Inc. shares rose sharply early Tuesday after US regulators reversed course and recommended that patients ...
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 ...
FDA probes Elevidys after an 8-year-old's death in Brazil; Sarepta and Roche say the death was unrelated to gene therapy ...
While Sarepta has now consented to the FDA’s request to stop selling Elevidys, the company’s brief standoff with the agency ...
The European Medicines Agency determined testing failed to prove Elevidys’ benefit and issued a negative opinion that could ...
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 ...
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.
The FDA is set to request Sarepta Therapeutics to halt shipments of its gene therapy, Elevidys, after a third patient's death ...
– 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 ...
The U.S. Food and Drug Administration (FDA) is investigating the death of an eight-year-old boy who received Sarepta ...
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