News

Sarepta Needs to Show FDA Elevidys Won’t Cause More Deaths
The Food and Drug Administration won’t sign off on Sarepta Therapeutics Inc. bringing its controversial gene therapy back to ...
Elevidys Halt Sparks Analyst Downgrades—Sarepta Races To Revise Label
Analysts downgraded Sarepta as FDA pause on Elevidys raises regulatory uncertainty, leading to significant stock pressure and ...
PharmExec10h
Recapping the Sarepta Saga—And Implications for Industry
A timeline of key developments surrounding Sarepta Therapeutics' Duchenne muscular dystrophy drug Elevidys, and the potential ...
InnovationRx: Sarepta Blinks In Showdown With FDA
In this week’s edition of InnovationRx, we look at Moderna’s use of quantum computers, a new top drug regulator at the FDA, ...
Roche pauses shipments of Elevidys gene therapy outside US
Roche Holding AG said on Tuesday it has paused shipments of muscular disorder gene therapy Elevidys in some countries outside ...
Fierce Pharma16h
Roche halts Elevidys distribution in some countries, following Sarepta's lead in US
Roche is pausing shipments of Elevidys in some countries, following partner Sarepta Therapeutics’ move in the U.S., as safety ...
BioSpace19h
Following Sarepta’s Lead, Roche Suspends Elevidys Shipments to Some Ex-US Countries
Discovered and developed by Sarepta Therapeutics, Elevidys is a gene therapy that won accelerated approval in June 2023 and ...
Sarepta stock faces multiple downgrades and questions of solvency amid Elevidys pause
For Sarepta, the hits keep coming, with several downgrades in the past week after it was forced to temporarily take its ...
BioPharma Dive15h
Roche stops shipping Sarepta gene therapy in some countries outside US
The Swiss company, which markets Elevidys abroad, said it believes the benefit-risk balance to treatment remains positive in ...
STAT22h
Roche halts some shipments of Sarepta’s Duchenne gene therapy outside U.S.
Roche is following its partner Sarepta and halting shipments of the Duchenne gene therapy Elevidys in some countries, amid ...
Roche pauses Sarepta gene therapy shipments outside the U.S.
Sarepta Therapeutics (SRPT) stock is back in focus as Roche (RHHBF) pauses global shipments of its Elevidys gene therapy ...
Sarepta cut to Underperform at BofA on Elevidys concerns
Sarepta Therapeutics (SRPT) stock is downgraded at Bank of America based on safety concerns related to the company's Elevidys gene therapy for Duchenne. Read more here.