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2don MSN
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 faces an “arduous and treacherous path” to try to get its Duchenne muscular dystrophy therapy Elevidys back onto the market
Sarepta Therapeutics is pausing shipments of its gene therapy for muscular dystrophy following several patient deaths that have attracted attention from regulators
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.
Sarepta Therapeutics shares traded lower in premarket trade on Tuesday, as the drugmaker relented to a Food and Drug Administration request to halt the shipments of a gene therapy.
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Shipments will halt by close of business Tuesday evening, the company said. Sarepta had initially rejected the agency’s request, which was issued Friday.
Arrowhead Pharmaceuticals has moved to reassure Wall Street about its deal with Sarepta Therapeutics, telling investors that it expects its troubled R&D partner to meet its financial obligations.
The FDA has placed multiple investigational gene therapy clinical trials on hold, signaling broader platform concerns.
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.
2don MSN
Sarepta Therapeutics' (SRPT) stock continued to sink Tuesday 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,
Analysts downgraded Sarepta as FDA pause on Elevidys raises regulatory uncertainty, leading to significant stock pressure and valuation cuts.