Financial PositionThe company's current cash position of $489.9M is expected to fund its operational plans into 2028, providing strong financial backing for future development.
Market ExpansionThe company's engagement with the EMA for potential EU approval indicates a strategic move to capture both US and EU markets.
Regulatory ApprovalBitopertin is on the path for accelerated approval after a successful meeting with the FDA, which aligns with the design for the post-marketing confirmatory Phase 3 study.