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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. <\/p>\n
Story Continues <\/p>\n
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. <\/p>\n
DFTX’s Next Steps in the DT120 Clinical Program <\/p>\n
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 \u00b5g 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. <\/p>\n
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. <\/p>\n
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. <\/p>\n
Definium Therapeutics, Inc. Price and Consensus Definium Therapeutics, Inc. price-consensus-chart | Definium Therapeutics, Inc. Quote <\/p>\n DFTX’s Zacks Rank and Stocks to Consider <\/p>\n Definium currently carries a Zacks Rank #3 (Hold). <\/p>\n Some better-ranked stocks in the biotech sector are Precigen PGEN, currently sporting a Zacks Rank #1 (Strong Buy), and AC Immune ACIU and Aldeyra Therapeutics ALDX, carrying a Zacks Rank #2 (Buy) each. You can see the complete list of today’s Zacks #1 Rank stocks here. <\/p>\n 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. <\/p>\n 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%. <\/p>\n 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. <\/p>\n AC Immune’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 33.25%. <\/p>\n 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. <\/p>\n Aldeyra Therapeutics’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 29.25%. <\/p>\n Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report<\/a> <\/p>\n Definium Therapeutics, Inc. (DFTX) : Free Stock Analysis Report<\/a> <\/p>\n Aldeyra Therapeutics, Inc. (ALDX) : Free Stock Analysis Report<\/a> <\/p>\n AC Immune (ACIU) : Free Stock Analysis Report<\/a> <\/p>\n Precigen, Inc. (PGEN) : Free Stock Analysis Report<\/a> <\/p>\n This article originally published on Zacks Investment Research (zacks.com).<\/a> <\/p>\n