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BioMarin, as expected, sees delay to FDA review of hemophilia gene therapy

While not surprising, the delay is a disappointment for BioMarin, which has already spent years trying to win U.S. approval of its gene therapy known as Roctavian.

The company appeared on track to bring a long-lasting therapy to patients who suffer from the genetic bleeding disease back in 2019, when it first sought approval for Roctavian. The next year, the FDA surprised the gene therapy world by rejecting it, saying the agency needed more evidence that the one-time treatment would provide lasting benefit.

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