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StocksMediumUpdated•Originally published 14 September 2026•Updated 14 September 2026•
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Definium Says Pivotal Panorama Trial of Investigational DT120 Succeeded in Generalized Anxiety Disorder

Key Facts

1Panorama met its primary endpoint with a -5.1-point placebo-adjusted HAM-A difference at Week 12, with p<0.0001 and d=0.64.
2The study enrolled 245 adults randomized 2:1:2 to 100 µg, 50 µg or placebo.
3Treatment-emergent adverse-event rates were 94.8%, 96.1% and 62.9% in the 100-µg, 50-µg and placebo groups, respectively.
4Definium plans a pre-NDA meeting in Q4 2026 and expects to file an NDA in H1 2027.

Definium Therapeutics said the Phase 3 Panorama study of investigational DT120 ODT met its primary endpoint in generalized anxiety disorder. At Week 12, the adjusted mean change in HAM-A score was -9.8 points with the 100-µg dose versus -4.7 points with placebo, a -5.1-point difference with p<0.0001 and an effect size of d=0.64.

The study enrolled 245 adults aged 18 to 74 across about 32 centers. Participants were randomized 2:1:2 to receive a single 100-µg dose of DT120 ODT, a 50-µg control dose or placebo; the 100-µg and placebo groups included 96 and 97 participants, respectively.

Panorama's protocol comprises a 12-week randomized, double-blind Part A followed by a 40-week open-label Part B. Eligible participants in the extension may receive up to 4 additional 100-µg doses of DT120 ODT, bringing the total study duration to about 56 weeks.

The company said the trial also met all key secondary endpoints. The placebo-adjusted HAM-A difference at Week 1 was -5.3 points, while the CGI-S differences were -0.8 points at Day 2 and -0.6 points at Week 12; all 3 comparisons had p<0.0001.

At Week 12, 32% of the 100-µg group achieved a HAM-A response, defined as a reduction of at least 50%, versus 14% with placebo. Remission rates were 15% versus 4%, while 35% versus 17% had symptoms rated mild or better.

Definium said most treatment-emergent adverse events were mild to moderate, transient and concentrated on dosing day, with no drug-related serious adverse events or suicidality signal. Event rates were 94.8% with 100 µg, 96.1% with 50 µg and 62.9% with placebo.

Participants were monitored for at least 8 hours on dosing day. In the 100-µg group, the average time to meet end-of-session criteria was 6.2 hours and the median was 6.0 hours, with 94% meeting the criteria by Hour 8. That duration highlights the potential operating burden for treatment sites if similar monitoring conditions carry into any future commercial use.

These company-reported topline findings do not constitute regulatory approval; the FDA says evidence of effectiveness is necessary but not sufficient for approval, which also requires a safety determination. Definium has scheduled a pre-NDA meeting for Q4 2026 and expects to file an NDA in H1 2027.

DFTX closed at $38.89 on September 11, 2026, after reaching an intraday high of $39.37. Because both figures predate the September 14, 2026 Panorama announcement, they cannot measure the market's reaction to the results.