New York, June 22, 2026, 09:02 (EDT)
- Definium reported its Phase 3 Emerge trial for DT120 hit the primary endpoint in major depressive disorder, showing an 8.1-point placebo-adjusted benefit after six weeks.
- DFTX looked set for a strong open on the Nasdaq. Before the bell, Public.com quoted the shares at $40.19 at 9:00 a.m. ET, up 64.2% from where they finished last session.
- The key question now is if the result sticks through the wider regulatory process, which still includes another depression trial and possible risk tied to controlled-substance scheduling.
Definium Therapeutics Inc. NASDAQ:DFTX surged in pre-market trading after the company said its LSD-based DT120 tablet hit the main target in a late-stage depression trial. The New York biotech traded at $40.19 on Public.com at 9:00 a.m. ET, up 64.2% from Friday’s close of $24.48. Nasdaq’s session hadn’t started yet, with the open set for 9:30 a.m. ET.
Timing is key here. NASDAQ:DFTX has been trading through 2026 with a focus on its pipeline calendar. Emerge is the first Phase 3 readout for major depressive disorder from the group of DT120 trials investors have tracked since the company changed its name from MindMed earlier this year.
Definium said its DT120 ODT pill — an orally disintegrating LSD tablet — posted an 8.1-point placebo-adjusted drop on the Montgomery-Åsberg Depression Rating Scale at week six. MADRS scores are clinician-rated, with lower figures showing fewer depression symptoms. At week one, the company reported a 14.2-point benefit versus placebo; by week 12, a 7.3-point gap. There were no serious adverse events and no signs of suicidality. CEO Rob Barrow called the results “rapid, robust, and durable.” Investigator John Sonnenberg said the benefit was “meaningful and durable.” Business Wire
Another thing for the technical crowd is the responder math. Emerge’s response rate for DT120 came out at 35%, while placebo was 7%, so a 28-point difference. That works out to a number needed to treat of about four. In other words, four people would need DT120 to get one additional responder compared to placebo. For remission, rates were 24% with the drug and 3% on placebo, giving an NNT of about five.
The stock surged. Jefferies analysts said earlier this month that a 4- to 5-point placebo-adjusted week-six effect with staying power would count as a strong showing, but Definium’s 8.1-point week-six split was 62% above the top of that range and more than double the low end.
Peer reaction is limited, but it’s there. Compass Pathways NASDAQ:CMPS, which also works on psychedelic treatments for depression, logged a second positive Phase 3 trial for its COMP360 psilocybin in treatment-resistant depression this year; latest data had CMPS up 4.8%. That’s a smaller gain, though the risk profile is similar.
Balance sheets matter for clinical-stage biotechs, which often tap into surging share prices to raise cash. Definium said in May it held $373.4 million in cash, cash equivalents and investments as of March 31. The company expects that will last into 2028 under its current plan. Research and development spending jumped to $41.5 million in the first quarter from $23.4 million a year ago.
But a Phase 3 win doesn’t mean FDA approval. Definium, in its annual report, said it hasn’t generated revenue yet, expects to keep posting losses, and is developing drugs that include Schedule I controlled substances. So, even with FDA clearance, there would be DEA and state scheduling to deal with, plus commercial site limits and questions about market access.
Monday is shaping up as a gap-risk event for traders, not just another routine biotech note. If DFTX keeps its pre-market level through the open, it will start above its previous 52-week high. But if it gives up those gains, focus could shift from the clinical results to how much approval risk investors had already factored in, ahead of the next depression study and any regulatory decision.
