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The Latest Breaking News from SRPT

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

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

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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 Reverses Course, Pauses Elevidys Shipments Amid FDA Safety Review

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.

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.

Benzinga

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Why Sarepta Therapeutics Shares Are Trading Higher By 34%; Here Are 20 Stocks Moving Premarket

Shares of Sarepta Therapeutics, Inc. (NASDAQ:SRPT) rose sharply in pre-market trading after the company announced it will engage in strategic restructuring and cost savings.

Benzinga

Top 3 Health Care Stocks That Could Blast Off In July

The most oversold stocks in the health care sector presents an opportunity to buy into undervalued companies.

Benzinga

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

MarketBeat

Sarepta Crashes 37% After Its Gene Therapy Flops Its Biggest-Ever Test

Sarepta Therapeutics' gene therapy, Elevidys, faces an uphill regulatory journey, analysts said Tuesday on mixed test results.

Investors Business Daily

Sarepta Plummets Despite Winning FDA Nod For $3.2 Million Gene Therapy

Sarepta won approval Thursday for its highly anticipated Duchenne muscular dystrophy gene therapy. SRPT stock yo-yoed in response.

Investors Business Daily

Sarepta Therapeutics Dives On An Unexpected Holdup For Its Gene Therapy

The FDA pushed back its review of a highly anticipated gene therapy from Sarepta Therapeutics on Wednesday, prompting SRPT stock to tumble.

Investors Business Daily

Dow Jones Futures Rise In Dangerous Market; Sarepta Soars On FDA News

Sideways action is far more dangerous than a bear market because it lures investors in. Here's what to do now. Sarepta surged on an FDA panel vote.

Investors Business Daily

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Investors Business Daily

Sarepta Stock Catapults Higher After Eking Out A Narrow Win In Its Gene Therapy Battle

Shares of SRPT stock launched Monday after FDA advisors voted late Friday in support of a highly anticipated gene therapy from Sarepta.

Investors Business Daily

Sarepta Tumbles As Report Of Internal FDA Strife Scorches Its Gene Therapy

Several FDA staffers were leaning toward rejecting a highly watched gene therapy from Sareptas, according to a report Thursday.

Investors Business Daily

Sarepta Crashes On An Unexpected Roadblock For Its Gene Therapy

In a surprise decision, the FDA will hold an advisory committee to discuss Sarepta's gene therapy, and SRPT stock tanked Friday.

Investors Business Daily

Sarepta Rockets And Breaks Out As FDA Smooths The Path For Its Gene Therapy

Sarepta could snag an accelerated approval for its muscular dystrophy gene therapy, analysts suggested Wednesday as SRPT stock rocketed.

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Investors Business Daily

Sarepta Surges As It Nears The Finish Line With A Muscular Dystrophy Gene Therapy

The FDA said Monday it will perform a speedy review of Sarepta Therapeutics' muscular dystrophy gene therapy, and SRPT stock jumped.

Investors Business Daily

Dow Jones Futures Fall: Market Rally Reeling As Fed's Powell Signals Higher Peak Rate

Futures fell after the stock market sold off Wednesday on Fed chief Jerome Powell hinting at slower rate hikes but also a higher peak rate.

Investors Business Daily

Why IBD Stock Of The Day Sarepta Just Snagged A Price Target Hike Over Pfizer

IBD Stock Of The Day Sarepta will lead the gene therapy market in treating a form of muscular dystrophy, an analyst said Monday.

Benzinga

Sarepta Reports One Heart Inflammation Case In Duchenne Gene Therapy Trial

Sarepta Therapeutics Inc (NASDAQ:SRPT) shared new functional data across multiple studies from the SRP-9001 (delandistrogene moxeparvovec) program for Duchenne muscular dystrophy. SRP-9001 is an investigational gene therapy under development in partnership with Roche Holdings AG (OTC:RHHBY). Results from Cohort 1 demonstrated a 3.8-point improvement and 3.2-point improvement on the Duchenne functional scale 52 weeks after…

Benzinga

Where Sarepta Therapeutics Stands With Analysts

Over the past 3 months, 5 analysts have published their opinion on Sarepta Therapeutics (NASDAQ:SRPT) stock. These analysts are typically employed by large Wall Street banks and tasked with understanding a company's business to predict how a stock will trade over the upcoming year.

Benzinga

Sarepta Bets On GenEdit's Nanoparticles' In $57M Gene Editing Partnership

Sarepta Therapeutics Inc (NASDAQ: SRPT) will pay GenEdit up to

Benzinga

Analyst Ratings For Sarepta Therapeutics

Over the past 3 months, 6 analysts have published their opinion on Sarepta Therapeutics (NASDAQ:SRPT) stock. These analysts are typically employed by large Wall Street banks and tasked with understanding a company's business to predict how a stock will trade over the upcoming year.

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