Financial PerformanceSoleno ended 2024 with $318.6M in cash, cash equivalents, short- and long-term investments; these resources are expected to be sufficient to fund operations through the DCCR launch and possibly cash flow breakeven.
Launch TimelineAssuming DCCR approval in late March 2025, Soleno is expected to start generating revenue in mid-2025.
Regulatory ChallengesThe FDA accorded Priority Review to this NDA, which originally conferred a Prescription Drug User Fee Act (PDUFA) action date of December 27, 2024, and extended the PDUFA date late last year.