Every material Form 8-K Definium Therapeutics, Inc. has filed with the SEC since August 12, 2026, read and summarized by AI: what happened, the key figures, whether it reads positive or negative for shareholders, and how big a deal it is (impact 1-5). Newest first; each brief links to its own page and to the filing on SEC.gov.
Definium Therapeutics announced positive topline results from Panorama, its second Phase 3 study of DT120 ODT in generalized anxiety disorder, meeting its primary endpoint and all key secondary endpoints. The filing also posted a presentation on the company website, and the company plans a pre-NDA meeting with the FDA in 4Q 2026 and an NDA filing in 1H 2027.
Primary endpoint met: placebo-adjusted HAM-A change of 5.1 points at Week 12 for the 100 µg dose (p<0.0001), with 96 participants in the 100 µg group and 97 on placebo
Company reports the drug was generally well tolerated, with no drug-related serious adverse events and no new safety signals identified
Pre-NDA meeting scheduled for 4Q 2026; NDA filing anticipated in 1H 2027
Webcast to review results held at 8:00 a.m. EDT on September 14, 2026
Definium Therapeutics said the U.S. Food and Drug Administration granted Breakthrough Therapy designation to DT120 ODT for major depressive disorder. This is the program's second Breakthrough Therapy designation, following one for generalized anxiety disorder. The filing reports no financial figures, and the designation is based on Phase 3 Emerge study results.
FDA granted Breakthrough Therapy designation for DT120 ODT in major depressive disorder, announced September 8, 2026
Second Breakthrough Therapy designation for the DT120 program, after the designation for generalized anxiety disorder
Phase 3 Emerge study: single 100 µg dose showed an 8.1-point placebo-adjusted MADRS improvement at Week 6 (p<0.0001)
Definium Therapeutics announced positive topline results from Voyage, its first Phase 3 study of DT120 ODT in generalized anxiety disorder, meeting its primary and all key secondary efficacy endpoints. The filing reports a placebo-adjusted HAM-A change of 5.4 points at Week 12 (p<0.0001) and states the drug was generally well tolerated, with no new safety signals identified. The results support the company's development program, but the filing does not describe any regulatory approval, and the second Phase 3 GAD study, Panorama, is expected to report topline results in September 2026.
Primary endpoint: HAM-A change of -11.6 for DT120 ODT versus -6.2 for placebo at Week 12, a difference of -5.4 points (p<0.0001)
Study enrolled 214 participants across approximately 35 U.S. sites; 107 received DT120 ODT and 107 received placebo in the reported highlights
Company reported no suicidality signal or suicidal behavior; the average time to meet end-of-session criteria was 6.4 hours
Panorama, the second Phase 3 GAD study, has a topline readout anticipated in September 2026
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