Roche pauses Sarepta gene therapy shipments outside U.S.
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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,
Sarepta Therapeutics (NASDAQ:SRPT) faces an “arduous and treacherous path” to bring its gene therapy Elevidys back to market, according to a STAT report citing a senior FDA official, suggesting the treatment’s license could be revoked amid ongoing safety concerns.
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Sarepta Therapeutics' (SRPT) stock continued to sink Tuesday, down more than 4% in pre-market trade, following a rough end to last week, including a previously unreported patient death in a clinical trial of an unnamed therapy and the threat of the FDA taking a different therapy,
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.
The FDA has placed multiple investigational gene therapy clinical trials on hold, signaling broader platform concerns.
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Sarepta Therapeutics' recent setbacks and restructuring have pressured Arrowhead's share price. Read why I am reiterating my bullish rating on ARWR stock.
Sarepta faces FDA scrutiny over Elevidys as analysts downgrade stock and warn of long-term debt risks amid market uncertainty.