PANORAMA Study Results
Definium Therapeutics reports topline results from the second Phase 3 PANORAMA study.
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The only provided article relevant to Definium Therapeutics is a headline-only Benzinga item; its text contains no additional information about the PANORAMA study, DT120, efficacy, safety, endpoints or statistical results beyond the report that topline results were issued.
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The provided Definium article does not identify the number of participants, treatment arms, dosing regimen, primary endpoint or timing of the second Phase 3 PANORAMA study.
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The other four supplied articles concern Needham analyst ratings for Cognex, Alcon, Neovolta and Ondas, respectively, and provide no relevant information about Definium Therapeutics or the DT120 PANORAMA study.
Definium Therapeutics reported positive topline results on September 14, 2026, from its PANORAMA Phase 3 trial of DT120, an orally disintegrating tablet containing lysergide, for generalized anxiety disorder in adults Yahoo Finance. The trial met its primary endpoint, showing DT120 at 100 micrograms reduced anxiety symptoms by 5.1 points more than placebo on the Hamilton Anxiety Rating Scale after 12 weeks.
CEO Robert Barrow said the results confirm DT120's "unprecedented efficacy" in anxiety treatment. The stock surged 11% to $43.50 at market open. This marks Definium's third pivotal win in 12 weeks, following positive Phase 3 data in depression and a first anxiety trial earlier in 2026 Yahoo Finance.
Trial Showed Strong Symptom Relief in 245 Patients
The PANORAMA study enrolled 245 adults with generalized anxiety disorder across U.S. clinical sites. Patients received a single 100-microgram dose of DT120 or placebo Yahoo Finance. At week 12, the DT120 group showed a 9.8-point drop in anxiety scores versus 4.7 points for placebo, a statistically significant difference ($p < 0.0001$).
Symptom relief began early: patients showed measurable improvement by day 2 on the Clinical Global Impression scale and by week 1 on full anxiety measures Yahoo Finance. A lower 50-microgram dose arm showed smaller benefits, confirming the drug worked in a dose-dependent manner and proving the drug's active effect over placebo.
Fast-Acting Single Dose Could Transform Anxiety Treatment
Current anxiety medications require daily pills and often take weeks to work. DT120's single-dose design addresses two major problems: poor adherence and delayed symptom onset Yahoo Finance. Scott Aaronson, a trial investigator, noted that "a single dose has the potential to hold a response for months without the patient managing a pill every day."
The drug uses Catalent's Zydis fast-dissolve tablet technology to deliver lysergide orally. Definium designed the trial with an active low-dose control arm to address FDA concerns about whether patients could tell they received an active drug, a challenge unique to psychedelic medicines Yahoo Finance.
Company Moves Toward FDA Submission Next Year
Definium holds $1.1 billion in cash and investments, funding operations into 2030 Yahoo Finance. The company plans a pre-NDA meeting with the FDA in the fourth quarter of 2026 to finalize regulatory strategy, followed by an NDA application filing in the first half of 2027.
Barrow highlighted the rapid momentum: "You can go an entire career without getting three pivotal wins like this... To get three in 12 weeks has certainly got to be up there amongst the most rapid succession of these readouts for a company of our size." Definium is also advancing Phase 3 trials in depression and planning a PTSD study for 2027 Yahoo Finance.
Safety Profile Clean, Mild Side Effects Observed
DT120 showed a clean safety profile with no serious adverse events or suicidality signals Yahoo Finance. Treatment-related side effects were mild and temporary, including transient psychedelic effects like visual illusions and mild nausea. No patients stopped the drug due to safety concerns.
Analysts at Stifel and Jefferies praised the results, noting the 5.1-point improvement closely matched the earlier VOYAGE anxiety trial. Jefferies said the back-to-back wins shift investor focus from clinical risk to whether Definium can successfully launch and market the drug Yahoo Finance.
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