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Definium Reports Second Phase III Success in Anxiety Disorder Program
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Key Takeaways
DFTX's phase III Panorama study evaluating DT120 ODT for GAD met its primary and all key secondary endpoints.
DT120 ODT delivered a 5.1-point placebo-adjusted HAM-A benefit at Week 12, with effects seen by day 2.
DFTX plans an FDA pre-NDA meeting in Q4 2026, followed by an NDA filing in the first half of 2027.
Definium Therapeutics (DFTX - Free Report) reported positive late-stage data for DT120 (lysergide) orally disintegrating tablet (ODT) in generalized anxiety disorder (GAD), strengthening the case for the company’s lead candidate as it moves toward regulatory review. The phase III Panorama study met its primary and all key secondary efficacy endpoints, making it the second positive phase III study for DT120 ODT in GAD and the third positive phase III readout for the candidate’s clinical-development program overall.
DT120 ODT is a proprietary, pharmaceutically optimized formulation of lysergide designed to improve absorption, bioavailability and tolerability. The candidate is intended to deliver a single-dose treatment approach rather than chronic daily administration.
The phase III Panorama study enrolled 245 adults aged 18 to 74 with GAD confirmed under the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), and a baseline score of at least 20 on the Hamilton Anxiety Rating Scale (HAM-A), an important measure of anxiety severity. Patients were then randomized 2:1:2 to receive either a single dose of DT120 ODT 100 micrograms, a 50-microgram control arm or placebo. The 12-week double-blind Part A is followed by a 40-week open-label extension in which eligible participants may receive up to four additional 100-microgram doses.
DFTX’s Phase III GAD Study Data in Detail
The primary endpoint of Definium’s phase III Panorama studywas the change from baseline in HAM-A score at week 12. At Week 12, GAD patients treated with 100 micrograms of DT120 ODT showed a 9.8-point improvement in HAM-A scores versus 4.7 points for placebo, resulting in a 5.1-point placebo-adjusted benefit. The result was statistically significant, with a standardized effect size of 0.64. Definium also reported that improvement emerged rapidly, with treatment effects seen as early as day two and sustained through all post-baseline assessments in Part A.
Year to date, Definium stock has skyrocketed 200.6% against the industry’s 2.9% decline.
Image Source: Zacks Investment Research
DT120 ODT also showed statistically significant benefits across key secondary measures, with placebo-adjusted improvements of 0.6 points in the Clinical Global Impression-Severity (CGI-S) scale at week 12, a clinician-rated measure of overall illness severity, 5.3 points in HAM-A at week one and 0.8 points in CGI-S at day two. At week 12, 32% of DT120-treated patients achieved a HAM-A response versus 14% on placebo, while remission rates were 15% and 4%, respectively.
Safety findings were broadly consistent with prior clinical experience. Most treatment-emergent adverse events (TEAEs) were mild to moderate, transient and concentrated on dosing day. In the 100-microgram group, the overall TEAE rate was 94.8% versus 62.9% for placebo, while discontinuation rates were similar at 10.4% and 10.3%, respectively. The most common dosing-day events were illusion, nausea and headache. No drug-related serious adverse events or suicidality signal was identified.
DFTX’s Next Steps in the DT120 Clinical Program
With Panorama data adding to positive phase III results from the Voyage study for GAD announced last month, Definium is assembling the late-stage package needed for regulatory engagement. The Voyage study had also met its primary and all key secondary efficacy endpoints, with DT120 100 µg showing a statistically significant and clinically meaningful reduction in anxiety following 12 weeks of treatment. Based on these results, the company has scheduled a pre-new drug application (NDA) meeting with the FDA for the fourth quarter of 2026 and plans to submit the NDA for DT120 ODT to treat GAD in the first half of 2027.
Beyond GAD, Definium is advancing DT120 ODT in major depressive disorder (MDD). DFTX’s phase III Emerge study delivered positive top-line results in June 2026, meeting its primary and key secondary endpoints. The company has also initiated another phase III MDD study (Ascend), designed to enroll about 165 participants and is expected to produce top-line results in 2027.
Definium is also expanding DT120 ODT into posttraumatic stress disorder (PTSD). The phase III Haven study is expected to begin in 2027 and is planned to enroll about 200 adults randomized to DT120 ODT 100 micrograms or placebo. The primary endpoint is expected to be the change in the Clinician-Administered PTSD Scale for DSM-5 at Week 8, adding another potential indication to the candidate’s development program.
Over the past 60 days, estimates for Precigen’s 2026 bottom line have improved from a loss of 2 cents to earnings per share of 25 cents. Over the same period, earnings estimates for 2027 have risen from 25 cents to 86 cents. PGEN shares have increased 63.7% year to date.
Precigen’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 108.96%.
Over the past 60 days, estimates for AC Immune’s 2026 loss per share have narrowed from 84 cents to 60 cents. Over the same period, earnings estimates for 2027 remained unchanged at 17 cents. ACIU shares have lost 15.3% year to date.
AC Immune’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 33.25%.
Over the past 60 days, loss per share estimates for Aldeyra Therapeutics have narrowed from 43 cents to 39 cents for 2026. Over the same period, estimates for 2027 loss per share have narrowed from 22 cents to 16 cents. ALDX shares have plunged 71.7% year to date.
Aldeyra Therapeutics’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 29.25%.
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Definium Reports Second Phase III Success in Anxiety Disorder Program
Key Takeaways
Definium Therapeutics (DFTX - Free Report) reported positive late-stage data for DT120 (lysergide) orally disintegrating tablet (ODT) in generalized anxiety disorder (GAD), strengthening the case for the company’s lead candidate as it moves toward regulatory review. The phase III Panorama study met its primary and all key secondary efficacy endpoints, making it the second positive phase III study for DT120 ODT in GAD and the third positive phase III readout for the candidate’s clinical-development program overall.
DT120 ODT is a proprietary, pharmaceutically optimized formulation of lysergide designed to improve absorption, bioavailability and tolerability. The candidate is intended to deliver a single-dose treatment approach rather than chronic daily administration.
The phase III Panorama study enrolled 245 adults aged 18 to 74 with GAD confirmed under the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), and a baseline score of at least 20 on the Hamilton Anxiety Rating Scale (HAM-A), an important measure of anxiety severity. Patients were then randomized 2:1:2 to receive either a single dose of DT120 ODT 100 micrograms, a 50-microgram control arm or placebo. The 12-week double-blind Part A is followed by a 40-week open-label extension in which eligible participants may receive up to four additional 100-microgram doses.
DFTX’s Phase III GAD Study Data in Detail
The primary endpoint of Definium’s phase III Panorama studywas the change from baseline in HAM-A score at week 12. At Week 12, GAD patients treated with 100 micrograms of DT120 ODT showed a 9.8-point improvement in HAM-A scores versus 4.7 points for placebo, resulting in a 5.1-point placebo-adjusted benefit. The result was statistically significant, with a standardized effect size of 0.64. Definium also reported that improvement emerged rapidly, with treatment effects seen as early as day two and sustained through all post-baseline assessments in Part A.
Year to date, Definium stock has skyrocketed 200.6% against the industry’s 2.9% decline.
Image Source: Zacks Investment Research
DT120 ODT also showed statistically significant benefits across key secondary measures, with placebo-adjusted improvements of 0.6 points in the Clinical Global Impression-Severity (CGI-S) scale at week 12, a clinician-rated measure of overall illness severity, 5.3 points in HAM-A at week one and 0.8 points in CGI-S at day two. At week 12, 32% of DT120-treated patients achieved a HAM-A response versus 14% on placebo, while remission rates were 15% and 4%, respectively.
Safety findings were broadly consistent with prior clinical experience. Most treatment-emergent adverse events (TEAEs) were mild to moderate, transient and concentrated on dosing day. In the 100-microgram group, the overall TEAE rate was 94.8% versus 62.9% for placebo, while discontinuation rates were similar at 10.4% and 10.3%, respectively. The most common dosing-day events were illusion, nausea and headache. No drug-related serious adverse events or suicidality signal was identified.
DFTX’s Next Steps in the DT120 Clinical Program
With Panorama data adding to positive phase III results from the Voyage study for GAD announced last month, Definium is assembling the late-stage package needed for regulatory engagement. The Voyage study had also met its primary and all key secondary efficacy endpoints, with DT120 100 µg showing a statistically significant and clinically meaningful reduction in anxiety following 12 weeks of treatment. Based on these results, the company has scheduled a pre-new drug application (NDA) meeting with the FDA for the fourth quarter of 2026 and plans to submit the NDA for DT120 ODT to treat GAD in the first half of 2027.
Beyond GAD, Definium is advancing DT120 ODT in major depressive disorder (MDD). DFTX’s phase III Emerge study delivered positive top-line results in June 2026, meeting its primary and key secondary endpoints. The company has also initiated another phase III MDD study (Ascend), designed to enroll about 165 participants and is expected to produce top-line results in 2027.
Definium is also expanding DT120 ODT into posttraumatic stress disorder (PTSD). The phase III Haven study is expected to begin in 2027 and is planned to enroll about 200 adults randomized to DT120 ODT 100 micrograms or placebo. The primary endpoint is expected to be the change in the Clinician-Administered PTSD Scale for DSM-5 at Week 8, adding another potential indication to the candidate’s development program.
Definium Therapeutics, Inc. Price and Consensus
Definium Therapeutics, Inc. price-consensus-chart | Definium Therapeutics, Inc. Quote
DFTX’s Zacks Rank and Stocks to Consider
Definium currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Precigen (PGEN - Free Report) , currently sporting a Zacks Rank #1 (Strong Buy), and AC Immune (ACIU - Free Report) and Aldeyra Therapeutics (ALDX - Free Report) , carrying a Zacks Rank #2 (Buy) each. You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Precigen’s 2026 bottom line have improved from a loss of 2 cents to earnings per share of 25 cents. Over the same period, earnings estimates for 2027 have risen from 25 cents to 86 cents. PGEN shares have increased 63.7% year to date.
Precigen’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 108.96%.
Over the past 60 days, estimates for AC Immune’s 2026 loss per share have narrowed from 84 cents to 60 cents. Over the same period, earnings estimates for 2027 remained unchanged at 17 cents. ACIU shares have lost 15.3% year to date.
AC Immune’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 33.25%.
Over the past 60 days, loss per share estimates for Aldeyra Therapeutics have narrowed from 43 cents to 39 cents for 2026. Over the same period, estimates for 2027 loss per share have narrowed from 22 cents to 16 cents. ALDX shares have plunged 71.7% year to date.
Aldeyra Therapeutics’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 29.25%.