Clinical Trial Failure Risk: Clinical trials for gene therapies are complex, lengthy, and expensive, and there is no guarantee that Rocket Pharma's product candidates will demonstrate sufficient safety and efficacy to achieve regulatory approval.

Regulatory Approval Uncertainty: Even if clinical trials are successful, obtaining necessary regulatory approvals from agencies like the FDA or EMA is a challenging process that can be delayed, denied, or subject to unforeseen conditions, impacting commercialization timelines.

Manufacturing and Supply Chain Complexities: Producing gene therapies involves highly specialized and complex manufacturing processes and supply chain logistics, which can lead to capacity constraints, quality control issues, or disruptions that delay product development or commercial availability.