Clinical Efficacy UncertaintyA proof-of-concept study for the potassium-channel activator failed to meet its primary endpoint in major depressive disorder and persistent questions about adequate brain exposure undermine confidence in the program's prospects.
Financial Runway And Pipeline OptionalityAvailable cash is limited relative to historical spending, prompting aggressive R&D cuts and delays to lower-priority trials that reduce pipeline optionality and raise the risk of missing value-creating data.
Regulatory SetbackA complete response letter for Vyglxia criticized the use of real-world data as a comparator, leaving the drug's approval pathway uncertain and removed from near-term valuation models.