Rocket Pharmaceuticals sold an FDA drug review fast pass tied to the accelerated approval of Kresladi for a rare pediatric indication, securing $180 million in non-dilutive capital. Rocket said proceeds will support its pipeline, including a gene therapy now in pivotal clinical testing for Danon disease. The priority review voucher is linked to Rocket’s earlier regulatory milestone, reflecting how FDA voucher mechanisms continue to provide balance-sheet support for late-stage genetics and cell/gene programs. For investors, the transaction underlines the value of regulatory catalysts that can translate into cash ahead of program commercialization, especially for developers pursuing expensive pivotal and manufacturing timelines.
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