Biopharma · FDA Approvals · Stock
DFTX Definium
Definium Therapeutics Inc is developing inventive, next-generation therapeutics intended to solve the underlying causes of psychiatric and neurological disorders and offer patients long-term remission rather than transient symptom reduction. Its late-stage pipeline includes four Phase 3 trials-two each for GAD and MDD-…
Assets on file: DT120 ODT
Catalyst calendar
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Recent first-hand events
Every first-hand event for DFTX, newest first.
DFTXDefiniumDefinium reports positive Phase 3 Panorama topline for DT120 ODT in GAD
Panorama met its primary endpoint and all key secondaries, showing a statistically significant 5.1-point placebo-adjusted HAM-A reduction at Week 12 (p<0.0001, d=0.64). This marks the third positive Phase 3 readout for DT120 ODT and the second in GAD, strengthening the regulatory package ahead of the planned pre-NDA meeting in 4Q 2026 and NDA filing in 1H 2027.
DFTXDefiniumDefinium starts second Phase 3 MDD study of DT120 ODT
First patient dosed in Ascend, the second Phase 3 pivotal trial of DT120 ODT in MDD. The 12-week double-blind portion is expected to read out in 2027, following the earlier Emerge study readout in late 2Q 2026.
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