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The FDA granted accelerated approval to Denali’s Hunter syndrome drug, offering patients hope after a string of tougher rare disease decisions. Sarepta, meanwhile, posted early but limited data on new RNA therapies, asking investors to buy back in after a difficult year.
Also, an approval from Corcept after it had an FDA miss with the same drug last year, and we await a high-stakes readout from off-the-shelf CAR-T player Allogene.
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