Sarepta

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Regenxbio's Duchenne gene therapy clears phase 3 hurdle

Regenxbio is pitching at FDA approval in 2027 for its Duchenne muscular dystrophy gene therapy RGX-202, a potential rival to Sarepta/Roche's Elevidys.

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Changes at the top of Sarepta, Alkermes, as CEOs depart

Two long-serving pharma CEOs have announced their departures, as Sarepta's Doug Ingram and Alkermes' Richard Pops announce their retirement.

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Sarepta rises after FDA adds warning label to Elevidys

Uncertainty ends Sarepta's Duchenne gene therapy Elevidys ends after an FDA label update, with the company's shares on the up despite restrictions.

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Sarepta shares slide as DMD treatment woes pile up

The ESSENCE trial of Sarepta's Vyondys 53 and Amondys 45 failed to hit its objective, placing their FDA accelerated approvals at risk.

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FDA gives the go-ahead to restart Elevidys shipments

Sarepta has restarted distribution of its Duchenne muscular dystrophy gene therapy Elevidys, but only for patients who can walk.

News

Sarepta backs down and pauses Elevidys shipments

The FDA seems to have won its staring contest with Sarepta over shipments of Elevidys, as the company blinks and agrees to a pause from today.

Regenxbio's Duchenne gene therapy clears phase 3 hurdle

Changes at the top of Sarepta, Alkermes, as CEOs depart

Sarepta rises after FDA adds warning label to Elevidys

Sarepta shares slide as DMD treatment woes pile up

FDA gives the go-ahead to restart Elevidys shipments

Sarepta backs down and pauses Elevidys shipments

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