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FDA Will Ask Sarepta to Halt Gene Therapy Shipments

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

U.S. regulators asked Sarepta Therapeutics (SRPT.O) on Friday to voluntarily halt shipments of its Elevidys gene therapy after a muscular dystrophy patient who received a different, experimental trea...

· 19h · on MSN

Sarepta Refused FDA’s Request to Halt Elevidys Shipments

· 2h · on MSN

Gene therapy maker Sarepta tells FDA it won't halt shipments despite patient deaths

· 20h

FDA prepares to ask Sarepta Therapeutics to stop all shipments of Duchenne muscular dystrophy therapy

A 51-year-old man died last month after receiving an experimental gene therapy developed by Sarepta Therapeutics for an ultra-rare form of muscular dystrophy, a company spokesperson confirmed Thursda...

· 1d

Exclusive: US FDA to request Sarepta to stop all shipments of gene therapy Elevidys, source says

· 1d

FDA to ask Sarepta to stop shipping Duchenne gene therapy

Hoodline5h

Sarepta Therapeutics Announces Layoff of 493 Employees, Including 80 in Ohio, Amid FDA Scrutiny and Stock Decline

Sarepta Therapeutics lays off 493 workers amid FDA probe, stock drop, and concerns over its gene therapy treatment, Elevidys.

19h

Sarepta Therapeutics Provides Statement on ELEVIDYS

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

STAT19h

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, following two deaths tied to the product.

Sarepta: Finally, A Little Relief For Bulls; I Expect More

Sarepta's cost-saving moves, FDA surprises, and pipeline potential position SRPT as a unique opportunity. Read here for an investment analysis.

Business Wire2d

Sarepta Therapeutics Announces Strategic Restructuring and Pipeline Prioritization Plan to Maintain Long-term, Sustainable Growth and Provides Update on ELEVIDYS Label

Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced a strategic restructuring plan

2don MSN

Sarepta to cut 500 jobs after gene therapy setback, shares jump

Sarepta Therapeutics said on Wednesday it would lay off 36% of its workforce, or about 500 employees, after the recent deaths of two patients who had received its gene therapy Elevidys.

Fierce Pharma5d

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 FDA leadership’s much-touted support for cell and gene therapies against rare diseases.

Avidity Biosciences: Three Accelerated Approval Shots Feels Excessive

Del-zota is designed for patients with mutations amenable to exon 44 skipping, which is just 7% of the overall DMD patient population, Avidity believes, although the biotech states that it is "the first of multiple AOCs we are developing for DMD".