Sarepta Gene Therapy Setbacks

News

Sarepta's Duchenne Therapy Sparked Fears

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.

Clinical Trials Arena on MSN · 13h

Sarepta refuses to pull gene therapy despite FDA request

Sarepta Therapeutics is refusing to pull its gene therapy Elevidys (delandistrogene moxeparvovec), despite a request from the FDA.

Bloomberg on MSN · 7h

Sarepta’s Duchenne Therapy Sparked Fears Even Before FDA’s Order

There were warnings to the FDA about Sarepta Therapeutics Inc. before US regulators asked the company to halt shipments of its gene therapy.

Sarepta's Setback Deepens With Another Gene Therapy Fatality

Sarepta Therapeutics (NASDAQ:SRPT) shares plummeted on Friday following reports of a third patient death linked to its gene ...

8hon MSN

Sarepta Faces Fresh Setback. Why Now’s Not the Time to Buy the Stock.

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

BioPharma Dive1d

5 questions on Sarepta, the FDA and a Duchenne gene therapy crisis

A standoff over Elevidys could have major consequences for Duchenne patients, gene therapy companies and the perception of ...

STAT4d

Pharmalittle: We’re reading about a GSK setback, another Sarepta gene therapy death, and more

In a surprise, a FDA advisory panel voted that risks tied to a GSK blood cancer drug called Blenrep outweighed the benefits ...

How The Negative Developments At Sarepta Therapeutics Impact Arrowhead Pharmaceuticals

Sarepta Therapeutics' recent setbacks and restructuring have pressured Arrowhead's share price. Read why I am reiterating my bullish rating on ARWR stock.

BioPharma Dive6d

Sarepta to lay off about 500 employees after Duchenne gene therapy setbacks

On a conference call, CEO Doug Ingram said the decision to cut 36% of the company's staff and halt several drug programs was ...

Devdiscourse4d

FDA Scrutiny Intensifies as Sarepta Gene Therapy Faces Dire Setbacks

The FDA is set to request Sarepta Therapeutics to halt shipments of its gene therapy, Elevidys, after a third patient's death ...

Zacks.com on MSN9h

SRPT Slides on Voluntary US Elevidys Shipment Pause Amid Scrutiny

Sarepta stock down as it halts U.S. Elevidys shipments after FDA pressure and safety concerns tied to patient deaths due to liver failure.

5don MSN

Sarepta to cut 500 jobs, add black-box warning on gene therapy

Sarepta Therapeutics will cut 500 jobs and add a serious warning on the label of its muscle-disorder gene therapy Elevidys, the drugmaker said on Wednesday, following the recent deaths of two patients ...

Barron's4y

Sarepta Stock Dropped 50% After Gene-Therapy Setback. What to Do Now.

Until Thursday, Sarepta Therapeutics led the race to prove that gene therapy could cure Duchenne muscular dystrophy, a genetic disorder that progressively weakens the muscles of children. Late ...

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