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STAT+: Denali Therapeutics, Corcept Therapeutics win FDA approvals

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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.

Continue to STAT+ to read the full story…

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Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox.

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.

Continue to STAT+ to read the full story…

Read More

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