The Latest Breaking News from Sarepta

Sarepta Therapeutics, Inc. (NASDAQ:SRPT) shares are trading lower Thursday after the company announced it will refinance $700 million worth of 1.25% convertible notes due 2027.

As investors rotate away from the Magnificent 7, buy-rated small-caps like Chemours, Hillenbrand, and Arrowhead Pharmaceuticals are gaining momentum thanks to smart deals, analyst upgrades, and fresh operational catalysts.

In May, FDA Commissioner Marty Makary named Vinay Prasad the next director of the U.S. Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER). Within three months, Prasad resigned.

As gene therapies continue to evolve as a promising frontier in medical treatment, regulatory scrutiny intensifies following safety concerns. Recent developments with Sarepta Therapeutics Inc (NASDAQ:SRPT) highlight the delicate balance between innovation and patient safety in the biopharmaceutical industry.

Stock of Sarepta Therapeutics Inc. (NASDAQ:SRPT) surged 41.05% in Tuesday pre-market following the U.S. Food and Drug Administration’s (FDA) recommendation to lift the voluntary hold on Elevidys, Sarepta’s gene therapy for Duchenne Muscular Dystrophy.

Sarepta Therapeutics Inc (NASDAQ:SRPT) shares were halted in extended trading Monday after the U.S. Food and Drug Administration (FDA) recommended the removal of a voluntary hold for 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.

On Friday, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a negative opinion on the conditional marketing authorisation (CMA) for Elevidys (delandistrogene moxeparvovec) for ambulatory individuals aged three to seven years with Duchenne muscular dystrophy (DMD).

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