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

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.

Sarepta Therapeutics' licensing partner Arrowhead Pharmaceuticals said on Wednesday it expects to receive near-term milestone payments from the drugmaker despite recent setbacks, including the death of a trial patient reported last week.

Shares of Cambridge, Mass.-based Sarepta have fallen by more than 90% in the last year amid safety concerns about its Elevidys, a gene therapy that treats Duchenne muscular dystrophy, following reports of sudden patient deaths. Sarepta recently halted sales of the treatment.

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

The Sarepta saga continues, with the FDA slapping a clinical hold across all of the company’s investigational limb girdle muscular dystrophy (LGMD) trials, while also revoking the biopharma’s gene therapy platform technology designation.

Sarepta stock has tanked. Most investors don’t see the drugmaker’s executive management as credible following the failure to disclose a patient death, a BMO survey suggests.