Definium Therapeutics reports positive Phase 3 Panorama data for DT120 ODT in anxiety
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.
Key points
- 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
The filing
Written by AI on Nov 9, 2026, 11:43 AM ET, from this filing only. Written later: this filing was briefed after the fact, when past filings were added to the site, so the brief may be read with hindsight; the filing itself is the record of what was known on September 14, 2026.
Briefs are written by AI from the filing text and can contain mistakes — open the filing before acting on anything. Impact (1-5) and tone are the AI's reading of the filing for shareholders, not a price forecast. Not investment advice.