Overview

• The COMPASS PWS Phase 3 trial of intranasal carbetocin 3.2 mg three times daily in 175 patients over 12 weeks showed no statistically significant improvement on the HQ-CT primary endpoint, with no separation on secondary measures.
• Acadia will discontinue development of carbetocin following the topline results, reporting a safety profile consistent with prior studies and a low rate of adverse events.
• Shares of Acadia fell roughly 11% to 12% in premarket trading after the announcement, while Soleno Therapeutics rose about 13%.
• CEO Catherine Owen Adams said the company expects over $1 billion in 2025 net sales from two approved products and outlined a pipeline with multiple Phase 2 and Phase 3 starts and data readouts through 2027.
• Analysts highlighted prior inverse-dosing signals and maintained bullish views on ACAD, as a recent Scorpion Capital short report challenged Soleno’s Vykat XR pricing and pediatric safety.