sarepta therapeutics elevidys

News

Sarepta, FDA and Elevidys

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,

Seeking Alpha on MSN · 9h

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.

BioPharma Dive · 2d

Sarepta stops Elevidys shipments after standoff with FDA

Company CEO Doug Ingram said the pause was necessary for Sarepta to maintain a "productive and positive working relationship" with the regulator.

Sarepta Therapeutics, FDA and Duchenne

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.

Fierce Pharma · 2d

Sarepta stands behind Elevidys after FDA requests gene therapy be pulled from market

As the controversy over the safety of Sarepta Therapeutics’ gene therapies comes to a head, the biotech is standing firm behind its approved Duchenne muscular dystrophy (DMD) treatment. | As the controversy over the safety of Sarepta Therapeutics’ gene therapies comes to a head,

STAT · 1d

Sarepta Therapeutics’ Duchenne therapy faces ‘arduous’ path back to market, senior FDA official says

Sarepta Therapeutics faces an "arduous path” to try to get its gene therapy for Duchenne muscular dystrophy back onto the market, a senior FDA official told STAT.

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 Pharma12h

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 ...

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 ...

Sarepta Therapeutics: Why Is SRPT Stock Crashing?

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

STAT5d

Sarepta Therapeutics crisis is huge blow to Duchenne families, company

The FDA will request Sarepta Therapeutics stop all shipments of Elevidys, its gene therapy for Duchenne muscular dystrophy, ...

Sarepta Therapeutics Provides Statement on ELEVIDYS

Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today issued the ...

5don MSN

Sarepta Therapeutics Stock Tumbles on Report of Third Death in Clinical Trial

Key Takeaways Sarepta Therapeutics shares were down nearly 25% early Friday morning.The tumble followed a report that a third ...

Results that may be inaccessible to you are currently showing.

Hide inaccessible results