Sarepta Elevidys FDA Challenges

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Sarepta soars

Sarepta soars after FDA says some patients can get Elevidys

Sarepta Therapeutics Inc. shares rose sharply early Tuesday after US regulators reversed course and recommended that patients who can walk be allowed to take its gene therapy Elevidys again.

Benzinga · 1d

FDA Probes Death Of 8-Year-Old Who Received Sarepta's Elevidys

FDA probes Elevidys after an 8-year-old's death in Brazil; Sarepta and Roche say the death was unrelated to gene therapy treatment.

Bloomberg on MSN · 1d

FDA Says Sarepta Can Resume Gene Therapy in Some Patients

In a major win for Sarepta Therapeutics Inc., US regulators are recommending that patients who can walk be allowed to take its gene therapy Elevidys again.

16h

Sarepta: SRPT Stock To $40?

This regulatory relief, combined with several other compelling catalysts, creates a pathway for the stock to potentially ...

19h

Sarepta Therapeutics Surges Over 40% In Tuesday Pre-Market: What's Going On?

Stock of Sarepta Therapeutics Inc. (NASDAQ: SRPT) surged 38.89% in Tuesday pre-market following the U.S. Food and Drug ...

1don MSN

Sarepta rises 2%; Barclays downgrades to underweight on liquidity and Elevidys concerns

Sarepta Therapeutics (NASDAQ:SRPT) shares dropped sharply premarket on Monday before paring losses as Barclays revised its ...

BioPharma Dive4d

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 ...

Investing.com South Africa4d

Sarepta stock falls after Elevidys fails to get backing by EU regulators

The European Medicines Agency’s drug advisory committee (CHMP) rejected Elevidys for children aged 3 to 7 years who are able ...

Seeking Alpha1y

Sarepta Therapeutics: Navigating Elevidys Towards FDA Approval

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 ...

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