Market Access ChallengesRisks to Soleno's success include slower-than-expected U.S. market uptake due to market access or reimbursement issues and potential long-term dilution risks.
Pricing ConcernsThe disclosed annualized pricing of $466,200 represents moderate upside to the original pricing assumption.
Regulatory TimelineThe 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.