sarepta therapeutics - Search News

News

FDA, Sarepta

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 the market until the company can persuade US regulators that it won’t cause more deaths,

Forbes · 12h

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, ARCH Venture's latest biotech company, and more.

Barron's on MSN · 1d

Sarepta Stock Falls. Why It’s Caving In to the FDA and What Comes Next.

The company agreed to voluntarily halt shipments of its experimental medicine Elevidys for Duchenne muscular dystrophy.

Roche pauses Sarepta gene therapy shipments outside U.S.

The Boston Globe · 1d

Sarepta Therapeutics says it will pause shipments of Duchenne gene therapy

Shipments will halt by close of business Tuesday evening, the company said. Sarepta had initially rejected the agency’s request, which was issued Friday.

Reuters · 18h

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 the U.S., echoing a similar decision by U.S. partner Sarepta Therapeutics .

Yahoo · 16h

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 Duchenne patients who can still walk, however.

2don MSN

Sarepta Therapeutics stock sinks further Tuesday, after halting shipment of bestselling drug Elvidys

Sarepta Therapeutics' (SRPT) stock continued to sink Tuesday, down more than 4% in pre-market trade, following a rough end to ...

13hon MSN

Arrowhead expects Sarepta to honor financial obligations

Arrowhead Pharmaceuticals (ARWR) stock gains as company reassures investors about financial obligations required from Sarepta ...

STAT14h

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 ...

1don MSN

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 ...

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 top-selling drug off the market.

Fierce Biotech14h

With $550M on the line, Arrowhead reassures investors about pact with troubled Sarepta

Arrowhead Pharmaceuticals has moved to reassure Wall Street about its deal with Sarepta Therapeutics, telling investors that ...

Sarepta Therapeutics: Why Is SRPT Stock Crashing?

The FDA has placed multiple investigational gene therapy clinical trials on hold, signaling broader platform concerns.

1don MSN

Sarepta Therapeutics’ stock slips further as company bows to FDA pressure to halt shipments

Sarepta Therapeutics shares traded lower in premarket trade on Tuesday, as the drugmaker relented to a Food and Drug ...

15hon MSN

Sarepta's licensing partner Arrowhead expects near-term payments despite setbacks

Sarepta Therapeutics' licensing partner Arrowhead Pharmaceuticals said on Wednesday it expects to receive near-term milestone ...

2don MSN

Sarepta Therapeutics stock sinks further Tuesday after halting shipment of bestselling drug Elevidys

Sarepta Therapeutics' (SRPT) stock continued to sink Tuesday following a rough end to last week, including a previously ...

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.

Some results have been hidden because they may be inaccessible to you

Show inaccessible results

News

FDA, Sarepta

Roche pauses Sarepta gene therapy shipments outside U.S.

Related topics