Fasedienol (PH94B)

PALISADE-1/2/3, FEARLESS trials. 4/1/24- Initiates PALISADE-3 study. 9/23/24- Initiates PALISADE-4. 1/10/25- Initiates repeat dose study. 5/23/25- Age of onset trial data at ASCP on May 28, 2025. 6/2/25- PALISADE-3 topline data in Q4 2025 & PALISADE-4 data in H1 2026. 11/13/25:- PALISADE-3 randomized portion complete; topline data expected Q4 2025; PALISADE-4 topline data expected H1 2026. 12/17/25:- PALISADE-3 Ph3 SAD trial failed primary endpoint; safety favorable; company reviewing results and FDA feedback plans. 02/12/26:- PALISADE-4 topline H1 2026; PALISADE-3 data reviewed; safety favorable with no severe or serious events. 05/08/26:- Randomized PALISADE-4 portion completed; topline results expected Q2 2026; OLE ongoing. 05/12/26:- PALISADE-3 OLE showed no new safety signals and improved LSAS/SPIN. PALISADE-4 topline Q2 2026; Repeat Dose topline Q3 2026. 06/09/26:- ICH E1 exposure target met. PALISADE-4 topline Q2 2026; Repeat Dose topline Q3 2026.