Definium Therapeutics, Inc. 8K

Definium Therapeutics reported positive, statistically significant Phase 3 Voyage topline results for DT120 ODT in generalized anxiety disorder, supporting a potential NDA filing and future commercialization.

Definium Therapeutics, Inc. furnished an investor presentation providing the topline results from its Phase 3 Voyage trial of DT120 ODT, a proprietary lysergide tartrate orally disintegrating tablet, in generalized anxiety disorder (GAD), showing that the study met its primary and key secondary endpoints with highly statistically significant and clinically meaningful improvements on the Hamilton Anxiety Rating Scale (HAM-A) and Clinical Global Impressions–Severity (CGI-S) versus placebo after a single dose, along with favorable tolerability and no new safety signals; the company also presented interim Part B extension data indicating further symptom improvement and increasing response and remission rates with additional open‑label treatments, and positioned these data, together with prior Phase 2b and other late‑stage programs, as supporting advancement toward a potential NDA submission and commercialization strategy for DT120 ODT in GAD and major depressive disorder.

Filing Facts

CIK

1813814

Ticker

DFTX

Form

8K

Source Type

fda

Accession

0001104659-26-094528

Alert Tier

7