Definium Therapeutics, Inc. (NASDAQ:DFTX) shares rose 20% after the company reported topline results from its Phase 3 Panorama study evaluating DT120 ODT in patients with generalized anxiety disorder.
The study met its primary endpoint and all key secondary efficacy endpoints. Participants receiving DT120 ODT 100 µg showed a statistically significant reduction in Hamilton Anxiety Rating Scale, or HAM-A, scores compared with placebo at Week 12.
The placebo-adjusted difference in HAM-A score from baseline was 5.1 points.
HAM-A Score Falls 9.8 Points With DT120 ODT
The least-squares mean change from baseline in HAM-A total score at Week 12 was -9.8 for participants receiving DT120 ODT 100 µg, compared with -4.7 for the placebo group.
The company reported an effect size of 0.64. Differences in efficacy were observed from Day 2 and were maintained at subsequent assessment points during the study.
The Panorama results represent the second positive Phase 3 study of DT120 ODT in generalized anxiety disorder and the third positive Phase 3 study of the drug overall, according to the company.
Previous Phase 3 results included the Emerge study in major depressive disorder, announced in June, and the Voyage study in generalized anxiety disorder, announced in August.
Company Reports Similar Discontinuation Rates
Definium said DT120 ODT 100 µg was generally well tolerated and that its safety profile was consistent with previous clinical experience.
Most treatment-emergent adverse events were reported as mild to moderate, transient and primarily occurring on the day of dosing.
Overall discontinuation rates were 10.4% for participants receiving DT120 ODT 100 µg and 10.3% for those receiving placebo.
The average time for participants receiving DT120 ODT 100 µg to meet end-of-session checklist criteria was 6.2 hours, with 94% meeting the criteria by hour eight.
Across more than 1,000 treatment sessions in the Phase 3 programme through September 10, 2026, 97% of participants met the end-of-session criteria by hour eight.
NDA Filing Planned for First Half of 2027
Definium has scheduled a pre-New Drug Application meeting for the fourth quarter of 2026.
The company expects to submit an NDA for DT120 ODT in the first half of 2027 following the results from its Phase 3 programme.
Definium Therapeutics stock price
