Definium Therapeutics, Inc. · MNMD · 8-K · Filed
Announces positive Phase 3 Panorama study results for DT120 ODT
MNMD
8-K
Other filings
Source: SEC EDGAR, accession 0001104659-26-107275 · Items 7.01, 8.01, 9.01
What did Definium Therapeutics, Inc. announce?
Definium Therapeutics reported positive topline data from its Phase 3 Panorama study of DT120 ODT for generalized anxiety disorder, meeting all primary and key secondary endpoints.
Key details
- DT120 ODT 100µg achieved a statistically significant reduction of 5.1 points in Hamilton Anxiety Rating Scale (HAM-A) score over placebo at Week 12 (p<0.0001).
- The study also showed statistically significant and clinically meaningful improvements in CGI-S at Day 2 and Week 12, and HAM-A at Week 1.
- DT120 ODT 100µg was generally well tolerated, with most adverse events being mild to moderate and transient; no new safety signals were identified.
- A pre-NDA meeting is scheduled for Q4 2026, with an NDA filing anticipated in H1 2027.
Why it matters
This 8-K reports a corporate disclosure at Definium Therapeutics, Inc.. The likely share-price reaction reads as positive.
Bullish