News

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 ...
Precision Medicine Online2d

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.

Sarepta says it won't comply with FDA request to stop shipping gene therapy Elevidys

The U.S. Food and Drug Administration is planning to ask Sarepta Therapeutics to voluntarily stop all shipments of its gene ...
Pharmaceutical Technology on MSN1d

CHMP rejects Elevidys in latest setback for Sarepta

In the latest of a string of issues Sarepta has faced, the CHMP said it was recommending against approval as the pivotal ...

Sarepta shares fall 37% as FDA questions future of key gene therapy

Shares of Sarepta Therapeutics fell close to 37% on Friday after reports emerged that the US Food and Drug Administration is ...
Fierce Pharma12d

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 ...
Managed Healthcare Executive7d

FDA Wants Elevidys Off the Market. Sarepta Said No.

Elevidys is a gene therapy approved to treat Duchenne muscular dystrophy. Last month, Sarapta halted sales of the therapy for non-ambulatory patients.
BioSpace15d

FDA Rejections: We Read 200 CRLs So You Don’t Have To

A journey through the FDA’s newly released complete response letters gave glimpses into the journeys to market for Eli ...
FierceBiotech9y

The FDA updates expanded access drug rules, and Sarepta plunges

The FDA has come up with a series of ... some added regulatory context on troublesome issues like the added threat of adverse ... before green-lighting the drug. But with Sarepta, ...
Seeking Alpha9y

Sarepta: The Path Forward (NASDAQ:SRPT) - Seeking Alpha

Sarepta didn't think it possible that the drug would be so beneficial. Yet, to FDA bureaucrats, actually walkingdoesn't matter, but the walking distance does, which the FDA argues is ...