Clinical EfficacyOpen‑label extension data from a Phase 3 study showed about a 50% median reduction in countable motor seizures for patients with Dravet syndrome with a favorable safety profile, supporting EPX‑100's potential competitive advantage in epilepsy.
Formulation InnovationBioequivalence results suggest the gastric‑retentive pitolisant can be initiated at the therapeutic dose without titration while maintaining efficacy, positioning a more tolerable, easier‑to‑use product versus the current formulation.
Regulatory FilingsAnalyst highlights an expected NDA submission for the pitolisant gastric‑retentive formulation in early 2026 after positive bioequivalence data, which could trigger a formal review and a clear regulatory milestone.