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The Latest Breaking News from Sarepta

What's Going On With Sarepta, Capricor And Other Gene Therapy Stocks On Wednesday?

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.

Benzinga

FDA Lifts Safety Hold On Sarepta's Muscular Dystrophy Gene Therapy—Wall Street Cheers

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.

Benzinga

Sarepta Stock Soars After FDA Says It Can Resume Drug Shipments

Sarepta stock soared after the FDA said the biotech company can resume shipments of a controversial gene therapy drug.

Investors Business Daily

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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.

Benzinga

Sarepta Gets Thumbs Down From Regulators Regarding Elevidys Gene Therapy

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).

Benzinga

Sarepta Therapeutics' Brutal Week Continues With Bad News Out Of Europe

Sarepta Therapeutics' brutal week continued Friday after European officials rejected the company's controversial gene therapy, Elevidys.

Investors Business Daily

The Hits Keep Coming For Sarepta. Why Its Latest Setback Creates A 'Dangerous Precedent.'

Sarepta stock plunged again Thursday on a report the FDA will require additional clinical testing to validate the safety profile of Elevidys.

Investors Business Daily

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Elevidys Halt Sparks Analyst Downgrades—Sarepta Races To Revise Label

Sarepta Therapeutics, Inc. (NASDAQ:SRPT) announced Monday it will voluntarily and temporarily pause all U.S. shipments of Elevidys, its gene therapy for Duchenne muscular dystrophy, effective July 22.

Benzinga

Sarepta shares slide again as drugmaker bows to FDA pressure to pause gene therapy

Sarepta Therapeutics is pausing shipments of its gene therapy for muscular dystrophy following several patient deaths that have attracted attention from regulators

The Independent UK

Sarepta Makes A 'Painful' Decision. Will It Help Rebuild Investors' Confidence?

Sarepta stock reversed higher Tuesday after the company said it would voluntarily stop all shipments of Elevidys, complying with the FDA.

Investors Business Daily

Sarepta Reverses Course, Pauses Elevidys Shipments Amid FDA Safety Review

Benzinga

Sarepta Faces Regulatory Showdown As Analysts Cut Price Targets

On Friday, the U.S. Food and Drug Administration placed Sarepta Therapeutics Inc.’s (NASDAQ:SRPT) investigational gene therapy clinical trials for limb girdle muscular dystrophy (LGMD) on a clinical hold.

Benzinga

Sarepta's 'Unprecedented Times' Continue As Company Rebukes The FDA

Sarepta stock took another dive Monday after the biotech company refused the FDA's request to voluntarily stop all shipments of Elevidys.

Investors Business Daily

Sarepta's Shocking Stand: Company Rejects FDA Request To Pull Gene Therapy Elevidys

The ground shook for Sarepta Therapeutics, Inc. (NASDAQ:SRPT) last week as the U.S. Food and Drug Administration (FDA), alarmed by a third patient death tied to its gene therapy platform, pulled a rare move: requesting a voluntary halt to Elevidys shipments. The company’s response? A resounding “no,” igniting a major…

Benzinga

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The Independent UK

Gene therapy maker Sarepta tells FDA it won't halt shipments despite patient deaths

Drugmaker Sarepta Therapeutics says it won’t comply with a request from U.S. regulators to halt all shipments of its gene therapy

Benzinga

Sarepta's Setback Deepens With Another Gene Therapy Fatality

Sarepta Therapeutics (NASDAQ:SRPT) shares plummeted on Friday following reports of a third patient death linked to its gene therapy pipeline this year, further clouding investor confidence despite the company’s recent efforts to provide clarity on its restructuring and FDA label plans.

Investors Business Daily

The FDA Will Reportedly Ask Sarepta To Stop Selling Elevidys. Shares Plummet.

Sarepta stock crashed Friday on reports the FDA will ask the biotech company to stop shipments of its approved gene therapy, Elevidys.

Benzinga

Sarepta Therapeutics' Reorganization Boosts Investor Confidence

Sarepta Therapeutics, Inc. (NASDAQ:SRPT) stock is trading higher on Thursday after the company issued an after-hours update on ongoing label expansion efforts for Elevidys, its approved gene therapy for Duchenne muscular dystrophy.

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Investors Business Daily

Sarepta Catapults 20% On Restructuring Plans In The Wake Of Two Patient Deaths

Sarepta stock catapulted Thursday after the company announced a restructuring that includes 500 layoffs in the wake of two patient deaths.

Investors Business Daily

Sarepta Therapeutics Is Already Down 86% This Year. And The Other Shoe Just Dropped.

Sarepta stock dropped again Wednesday after the FDA announced it's investigating the deaths of two patients who received Elevidys.

Investors Business Daily

The FDA Shake-Up Continues, And Could Impact Genetic Medicines

The latest shake-up at the FDA forced out the top two officials in charge of reviewing cell and gene therapies, analysts said.

MarketBeat

Sarepta Drops 42% on Fatalities; Markets Eye Solid Biosciences

After a second patient passed away, Sarepta Therapeutics crashed. Solid Biosciences rose over 10% in response. Wall Street sees big upside in both names.

The Independent UK

Second patient death reported with gene therapy for muscular dystrophy

Shares of Sarepta Therapeutics have plunged again after the drugmaker reported a second death in connection with its gene therapy for muscular dystrophy

Investors Business Daily

Sarepta Crashes To Nine-Year Low After A Second Gene Therapy Patient Dies

Sarepta stock plummeted Monday after the company said a second patient died following treatment with its gene therapy, Elevidys.

MarketBeat

Pharma Fire Sale: 3 Stocks the RSI Says You Shouldn’t Ignore

These 3 pharma stocks have oversold RSIs and solid analyst support, setting up potential bounce-back trades through this week and next

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