Order byBest matchMost fresh

Roche pauses Sarepta gene therapy shipments outside U.S.

Digest more
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 concerns mount over the Duchenne muscular dystrophy gene therapy. | Roche is pausing shipments of Elevidys in some countries,

Continue reading

BioPharma Dive · 4h
Roche stops shipping Sarepta gene therapy in some countries outside US
Roche pauses shipments of Elevidys gene therapy outside US
InnovationRx: Sarepta Blinks In Showdown With FDA
Last week, in a remarkable showdown, Sarepta Therapeutics refused to stop distribution of Elevidys, its therapy for the muscle-wasting disease Duchenne muscular dystrophy as the FDA had requested.

Continue reading

Sarepta falls after gene therapy maker pauses Elevidys shipments in US
Sarepta Faces Fresh Setback. Why Now’s Not the Time to Buy the Stock.
Sarepta Therapeutics’ Duchenne therapy faces ‘arduous’ path back to market, senior FDA official says
But it would be difficult for Sarepta to prove that any new safety protocols could eliminate the risk of liver injuries — which have been tied to the deaths of two patients — the official added.

Continue reading

Sarepta pares gains as report suggests an ‘arduous’ path for Duchenne drug
STAT · 1d
In surprise reversal, Sarepta Therapeutics says it will pause shipments of Duchenne gene therapy
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 valuation cuts.
Sarepta cut to Underperform at BofA on Elevidys concerns
Bank of America downgraded Sarepta Therapeutics (NASDAQ:SRPT) to Underperform from Neutral on Wednesday, becoming the latest brokerage to issue a bearish view on the company, citing safety concerns related to its Elevidys gene therapy marketed with Roche (OTCQX:RHHBY).
STAT7h
Pharmalittle: We’re reading about Sarepta’s ‘arduous’ path ahead, pharma’s reliance on China, and more
Sarepta faces an “arduous and treacherous path” to try to get its Duchenne muscular dystrophy therapy Elevidys back onto the market
Sarepta Therapeutics laying off dozens in Ohio, won't comply with FDA request to halt therapy
After the FDA request, Cambridge, Massachusetts-based Sarepta said in a statement that it will continue to ship the therapy to ambulatory people but maintain a halt it implemented June 15 for non-ambulatory patients after reporting to the FDA a case of acute liver failure in a patient who could not walk.
Arrowhead expects Sarepta to honor financial obligations
Arrowhead Pharmaceuticals (ARWR) stock gains as company reassures investors about financial obligations required from Sarepta (SRPT) under a 2025 deal. Read more here.
Sarepta Therapeutics stock sinks after FDA tells company to stop shipping its bestselling drug
Sarepta stock tanked Friday after a new patient death was uncovered, spurring an FDA request to halt shipments of an unrelated drug.
Drugmaker Refuses F.D.A. Request to Pull Treatment Linked to Patient Deaths
The regulator had asked Sarepta Therapeutics to halt all shipments of its therapy, Ele­vidys, after three patients died from liver failure after taking it or a similar treatment.
Feedback