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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...

· 13h · on MSN

Sarepta Refused FDA’s Request to Halt Elevidys Shipments

Southwest Journal · 1d

Breaking: Second Patient Death Prompts FDA Investigation of Sarepta’s Elevidys Gene Therapy

· 19h

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

The U.S. Food and Drug Administration will request Sarepta Therapeutics (SRPT.O) to voluntarily stop all shipments of its gene therapy, Elevidys, a source familiar with the matter told Reuters on Fri...

· 19h

Sarepta Therapeutics, Inc. (SRPT) Strategic Restructure and ELEVIDYS Label Update Call Transcript

· 21h

Sarepta shares slump after third patient death this year

13h

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:

19hon MSN

Sarepta shares plunge 40% as future of its gene therapy appears at risk

Shares of Sarepta Therapeutics plunged more than 30% on Friday as the future of its approved gene therapy appeared at risk. Sarepta has reported three patient deaths related to its gene therapies.

STAT13h

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

Fierce Pharma4d

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".