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FDA, Sarepta and gene

Sarepta shares slide again as drugmaker bows to FDA pressure to pause gene therapy

Shares of drugmaker Sarepta Therapeutics continued to sink Tuesday after the company said it would comply with a Food and Drug Administration request to pause shipments of its gene therapy following s...

· 5d

Sarepta tells FDA it won’t halt shipments despite patient deaths

· 6d · on MSN

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

· 1d

InnovationRx: Sarepta Blinks In Showdown With FDA

The latest twist in the saga followed a decision by Children’s Hospital Los Angeles to halt use of the drug while it was facing regulatory uncertainty.

· 2d

Sarepta falls after gene therapy maker pauses Elevidys shipments in US

· 2d

Sarepta pares gains as report suggests an ‘arduous’ path for Duchenne drug

10hon MSN

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,

Fierce Pharma7h

FDA weighs new study requirements for Sarepta to confirm safety of gene therapy Elevidys: report

Sarepta would need to conduct new analyses to validate the safety of Elevidys—which has had U.S. shipments paused by the company over a mounting string of controversies—to the FDA, Endpoints News reported Thursday, citing an unnamed senior FDA official.

3don MSN

Sarepta stock extends decline as company declines FDA call to withdraw drug

Sarepta Therapeutics traded lower on Monday, extending a slide as the company took the unusual step of refusing a Food and Drug Administration request to stop selling a drug tied to three deaths.

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.

BioSpace1d

Sarepta’s Wild Week, CDER’s New Leader, FDA Rejections, Manufacturing Billions

Sarepta Therapeutics faces serious FDA action after news broke of a third patient death, the FDA gets a new top drug regulator in George Tidmarsh, a handful of new drugs get turned away from the market and pharma companies continue to commit billions to reshoring manufacturing.

STAT1d

Pharmalittle: We’re reading about Sarepta’s ‘arduous’ path ahead, pharma’s reliance on China, and more

Sarepta faces an “arduous and treacherous path” to try to get its Duchenne muscular dystrophy therapy Elevidys back onto the market

FierceBiotech1d

With $550M on the line, Arrowhead reassures investors about pact with troubled Sarepta

Sarepta LGMD trials all hit by FDA hold amid newly surfaced safety concerns over gene therapy Arrowhead said it is on track to earn the $100 million DM1 milestone soon and pocket the remaining $200 million by the end of the year. If Sarepta fails to make ...

1don MSN

Sarepta's licensing patner Arrowhead expects near-term payments despite setbacks

Arrowhead Pharmaceuticals said on Wednesday it expects to receive near-term milestone payments from Sarepta Therapeutics as part of their licensing agreement, despite recent setbacks at the Cambridge,

STAT1d

FDA opens applications for new voucher program

A new biotech called Dispatch Bio launched today with the goal of developing a new, universal approach to try to treat any cancer using immunotherapy.