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Europe, gene therapy and Sarepta

Yahoo Finance · 28m

Sarepta woes mount as Duchenne gene therapy knocked back in Europe

The European Medicines Agency determined testing failed to prove Elevidys’ benefit and issued a negative opinion that could further jeopardize Sarepta’s financial future.

InvestorsHub on MSN · 55m

Sarepta shares drop after EU regulators reject Elevidys gene therapy

Shares of Sarepta Therapeutics Inc. (NASDAQ:SRPT) plunged 13% on Friday after a major regulatory blow in Europe. The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a negative opinion on Elevidys,

Europe moves to reject embattled Duchenne muscular dystrophy gene therapy

European regulators said that a Duchenne gene therapy should not be approved, imperiling the treatment that is also facing scrutiny in the U.S.

Investor's Business Daily on MSN39m

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 ...

Sarepta Fallout Continues with EU’s Negative Opinion of Elevidys in Ambulatory Patients

The European Union’s health regulatory agency did not endorse approving Elevidys for ambulatory patients with Duchenne ...

2h

Sarepta Therapeutics Acknowledges CHMP Negative Opinion for ELEVIDYS in the European Union

Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, acknowledges that the ...

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Sarepta Therapeutics says it will pause shipments of Duchenne gene therapy

Shipments will halt by close of business Tuesday evening, the company said. Sarepta had initially rejected the agency’s ...

Sarepta’s Future Increasingly Uncertain as FDA Eyes New Study for Elevidys

CBER is unanimously against Elevdiys’ return to the market without additional evidence, according to media reports citing an ...

Sarepta Therapeutics’ Duchenne therapy faces ‘arduous’ path back to market, senior FDA official says

Sarepta Therapeutics faces an "arduous path” to try to get its gene therapy for Duchenne muscular dystrophy back onto the ...

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