Elevidys

News

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.

News

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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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.

News

FDA probing deaths with DMD gene therapy Elevidys

The FDA has launched a formal investigation into two liver failure-related deaths in patients treated with Duchenne gene therapy Elevidys.

News

DMD gene therapy Elevidys linked to new liver failure case

Another death from liver failure has been seen with Roche and Sarepta's Duchenne muscular dystrophy therapy Elevidys, prompting a pause on treatment.

Regenxbio's Duchenne gene therapy clears phase 3 hurdle

Sarepta rises after FDA adds warning label to Elevidys

Sarepta shares slide as DMD treatment woes pile up

Sarepta backs down and pauses Elevidys shipments

FDA probing deaths with DMD gene therapy Elevidys

DMD gene therapy Elevidys linked to new liver failure case

OpenBind unveils its first AI model for drug discovery

Discover a new era of healthcare panel engagement: Grounded ...

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