Definium Therapeutics (DFTX) Stock Jumps 20% After LSD-Based Drug Hits Phase 3 Goal

TLDR

Definium Therapeutics (DFTX) stock jumped nearly 20% after its Phase 3 Panorama study of DT120 ODT met its primary endpoint in generalized anxiety disorder. Patients on DT120 ODT 100µg saw HAM-A scores drop 9.8 points vs. 4.7 points for placebo at Week 12. This is the third positive Phase 3 study for DT120 ODT overall, following two earlier trials in anxiety and depression. Discontinuation rates were nearly identical between drug and placebo groups (10.4% vs. 10.3%), suggesting good tolerability. Definium plans to file an NDA with the FDA in the first half of 2027, with a pre-NDA meeting scheduled for Q4 2026.

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Definium Therapeutics (DFTX) stock surged nearly 20% in premarket trading on Monday after the company announced positive topline results from its Phase 3 Panorama study, its LSD-based treatment DT120 ODT for generalized anxiety disorder (GAD).

Definium Therapeutics, Inc. (DFTX)

The stock has now nearly tripled in value this year, driven by growing regulatory and investor interest in psychedelic-based therapies.

The Panorama study met its primary endpoint and all key secondary efficacy endpoints. Patients taking a single 100-microgram dose of DT120 ODT saw their Hamilton Anxiety Rating Scale (HAM-A) scores fall by 9.8 points after 12 weeks. The placebo group saw a drop of just 4.7 points.

The placebo-adjusted difference came in at 5.1 points, with an effect size of 0.64.

What stands out is how quickly the drug appeared to work. Differences in efficacy were observed as early as Day 2 and were maintained throughout the study period.

Third Positive Phase 3 Result

The Panorama study is the third positive Phase 3 result for DT120 ODT overall. The earlier Voyage study in GAD was announced in August, and the Emerge study in major depressive disorder was reported in June.

CEO Robert Barrow said having two positive GAD studies helps address questions around what is actually driving the drug’s effect, which is a key point for regulators. He noted that roughly a dozen programs have tried and failed to win FDA approval for GAD over the past 20 years.

GAD affects around 26 million U.S. adults and is typically managed with antidepressants, anti-anxiety medications, and psychotherapy.

The 245-patient Panorama trial included a 50-microgram dose arm, added to reduce the risk of functional unblinding, where patients guess their treatment due to the drug’s distinct effects. At both doses, patients were still able to correctly identify when they were on the drug rather than placebo.

The higher 100-microgram dose showed stronger efficacy than the 50-microgram arm, which Barrow said makes for an easier conversation with regulators.

Tolerability and NDA Timeline

The safety profile was consistent with earlier studies. Most treatment-emergent adverse events were mild to moderate, transient, and mainly occurred on the day of dosing.

Overall discontinuation rates were nearly identical: 10.4% for the DT120 ODT group versus 10.3% for placebo.

Across more than 1,000 treatment sessions in the Phase 3 program through September 10, 2026, 97% of participants met end-of-session criteria by hour eight.

Definium has a pre-NDA meeting scheduled with the FDA for Q4 2026 and expects to submit a formal NDA in the first half of 2027.

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