Clinical Trial ConcernsQuestions remain on how the efficacy and safety of NBI-'845 will hold up from Phase 2 to Phase 3, with history of shrinking effect sizes in MDD drugs from Phase 2 to Phase 3.
Drug Development SetbacksSpruce indicated it will likely have more work to do, including conducting a confirmatory Phase 3 trial, which could delay the timeline for potential FDA filing for a number of years or indefinitely as the 203 data calls into question the efficacy of tildacerfont.
Financial PerformanceInvestors were disappointed by the 2024 Ingrezza sales guidance, particularly as the low end represents just 5% growth from 4Q23 annual run rate.