Registro de fonte primária
Nível de decisãoResultados topline
Definium relata topline positivo da Fase 3 Panorama para DT120 ODT no TAG (GAD)
Panorama met its primary endpoint and all key secondaries, showing a statistically significant 5.1-point placebo-adjusted HAM-A reduction at Week 12 (p<0.0001, d=0.64). This marks the third positive Phase 3 readout for DT120 ODT and the second in GAD, strengthening the regulatory package ahead of the planned pre-NDA meeting in 4Q 2026 and NDA filing in 1H 2027.
Fatos principais
- Arquivado
- 14 de set. de 2026, 12:02
- Evento
- Resultados topline
- Direção
- Positivo
- Empresa
DFTXDefinium- Ativo
- DT120 ODT
- Fonte
- SEC 8-K
- Confiança
- Com fonte
- cohen d
- 0.64
- response rate
- 32% vs 14%
- ham a ls mean change
- -9.8 vs -4.7
- placebo adjusted difference
- -5.1 (p<0.0001)
Trecho da fonte
EX-99.1 2 tm2625365d1_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 Definium Therapeutics Announces Positive Topline Results from Phase 3 Panorama Study of DT120 ODT in Generalized Anxiety Disorder Study met primary and all key secondary efficacy endpoints; Panorama is the second positive Phase 3 trial for DT120 ODT in GAD and the third positive Phase 3 trial for DT120 ODT Participants receiving DT120 ODT 100 µg achieved a statistically significant reduction in Hamilton Anxiety Rating Scale (HAM-A) score, with a placebo-adjusted change of 5.1 points from baseline at Week 12 (p<0.0001, Cohen’s d=0.64) DT120 ODT 100 µg was generally well tolerated, with a safety profile consistent with prior clinical experience Pre-NDA meeting scheduled in 4Q 2026; NDA filing anticipated in 1H 2027 Company to