Sarepta FDA Regulatory Issues

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Sarepta, FDA and Duchenne

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

While Sarepta has now consented to the FDA’s request to stop selling Elevidys, the company’s brief standoff with the agency could still carry major consequences for the Duchenne community.

Precision Medicine Online · 9h

Sarepta Halts Duchenne Gene Therapy Sales Amid FDA Scrutiny, Raising Concerns Over Financial Future

Wall Street analysts warn that if Sarepta Therapeutics doesn't resolve the Elevidys issues, it could jeopardize its ability to repay debt in 2027.

The Columbus Dispatch on MSN · 2d

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.

Sarepta drops

Forbes · 1d

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.

Bloomberg on MSN · 1d

Sarepta Shares Drop After FDA Asks for More Data on Elevidys

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 · 6h

Sarepta drops as report suggests FDA needs new trials for Elevidys

Sarepta Therapeutics (NASDAQ:SRPT) resumed its recent sell-off on Thursday after Endpoints News reported that the FDA would require the company to conduct new studies to address safety concerns and reintroduce its gene therapy,

PharmExec1d

Recapping the Sarepta Saga—And Implications for Industry

A timeline of key developments surrounding Sarepta Therapeutics' Duchenne muscular dystrophy drug Elevidys, and the potential ...

12hon MSN

Is This Stock a Buy After Soaring by 20% in 1 Day?

Key Points Sarepta Therapeutics' most crucial product is turning out to have severe safety issues. The company's efforts to improve its situation were well received, but this victory didn't last long.

Sarepta Faces Regulatory Showdown As Analysts Cut Price Targets

Sarepta faces FDA scrutiny over Elevidys as analysts downgrade stock and warn of long-term debt risks amid market uncertainty ...

Sarepta: Safety And Efficacy Flaws Undermine Gains On Restructuring News

Sarepta Therapeutics, Inc. faces setbacks with Elevidys, safety issues, and workforce cuts, raising concerns about its ...

Fierce Pharma10d

Ultragenyx takes another hit as FDA snubs AAV gene therapy over manufacturing issues

The manufacturing-related rejection for UX111 is more than a setback for Ultragenyx, as it also delays a key test of the new ...

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