Definium Completes DT120 Phase 3 GAD Readouts, Targets 2027 NDA

The Tip Desk · November 12, 2026 · 4 min read

Voyage and Panorama met primary endpoints, and cash of about $1.05 billion is said to fund operations into 2030.

Definium Therapeutics, Inc. (DFTX), a late-stage clinical biopharmaceutical company developing therapeutics for psychiatric and neurological disorders, reported positive topline results from two Phase 3 studies of DT120 ODT in generalized anxiety disorder and said it remains on track to file a new-drug application in the first half of 2027.

The company also received FDA Breakthrough Therapy Designation for DT120 ODT in major depressive disorder after previously reported Phase 3 Emerge results. Chief Executive Officer Rob Barrow said the Voyage and Panorama topline data, together with Emerge, demonstrated consistent, clinically meaningful results across three Phase 3 studies in GAD and MDD.

Voyage randomized 214 participants 1:1 to DT120 ODT 100 µg or placebo. The study met its primary endpoint and all key secondary efficacy endpoints. DT120 ODT showed a placebo-adjusted improvement of 5.4 points in Hamilton Anxiety Rating Scale total score from baseline at Week 12 (p<0.0001, Cohen’s d=0.81). The company said the drug was generally well tolerated, with no drug-related serious adverse events and no suicidality signal in Part A.

Panorama randomized 245 participants 2:1:2 to DT120 ODT 100 µg, DT120 ODT 50 µg control, or placebo. It also met the primary endpoint and all key secondary efficacy endpoints, with a placebo-adjusted HAM-A improvement of 5.1 points at Week 12 (p<0.0001, Cohen’s d=0.64). Tolerability findings in Part A matched Voyage’s: no drug-related serious adverse events and no suicidality signal.

Enrollment continues in Phase 3 Ascend in MDD, expected to enroll about 165 participants on the same 2:1:2 design. Topline data is expected in 2027. The company plans to initiate Phase 3 Haven in PTSD in 2027 with about 200 participants randomized 1:1 to DT120 ODT 100 µg or placebo, with CAPS-5 at Week 8 as the planned primary endpoint.

DT402, the company’s proprietary form of R(-)-MDMA, showed positive initial results in a Phase 2a trial in five adults with autism spectrum disorder. The 200 mg single-dose, single-arm, open-label study was exploratory and not powered for statistical conclusions. After treatment, the company said improvements were observed across several measures, including reduced rigidity and fixation, increased social engagement, greater empathy and closeness, and reductions in anxiety and irritability. The most common adverse events were euphoria, fatigue and enhanced relaxation. A study of multiple dosing paradigms is planned for 2027.

Cash, cash equivalents and investments were approximately $1.05 billion as of September 30, 2026, compared with $1.1 billion as of June 30, 2026, after an $805 million gross public offering in the second quarter. The company said that cash would be sufficient to fund operations into 2030.

Research and development expenses were $46.1 million for the three months ended September 30, 2026, up from $31.0 million a year earlier. The company attributed the year-over-year increase primarily to an $8.8 million rise in personnel-related costs, a $5.9 million rise in DT120 program expenses, and a $0.6 million rise in preclinical and other program expenses, partly offset by a $0.2 million decrease in DT402 expenses.

General and administrative expenses were $26.1 million, versus $14.7 million a year earlier. The company cited a $3.5 million increase in corporate and government affairs, a $3.4 million increase in commercial-preparedness expenses, and a $3.3 million increase in personnel-related expenses as it expanded organizational capabilities.

Net loss was $51.0 million for the three months ended September 30, 2026, compared with $67.3 million a year earlier. The company said the narrower loss was primarily due to a gain from the change in fair value of 2022 USD financing warrants and higher interest income, partly offset by increased operating expenses.

Definium is advancing commercial readiness and expanding organizational capabilities toward potential approval and commercialization. It is planning its first Commercial Day in the first half of 2027 to highlight the market opportunity for DT120 ODT and its launch preparations.