Rocket Pharmaceuticals said it raised $180 million by selling an FDA drug review fast pass tied to an accelerated approval for Kresladi, a rare pediatric disease priority review voucher. Rocket framed the capital as non-dilutive funding to extend development of its pipeline, including a gene therapy in pivotal testing for Danon disease. The voucher followed the accelerated FDA approval for Kresladi in March, and Rocket positioned the sale as a way to keep pivotal timelines moving without drawing on equity markets. In gene therapy, late-stage execution and manufacturing readiness can be capital intensive. The fast pass monetization model offers a potential runway for teams preparing for regulatory review and scale-up ahead of key milestones. The update matters for investors tracking how rare-disease developers finance pivotal programs after FDA accelerated approvals.
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