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MDD: Emerge topline data readout on track for late 2Q 2026; Ascend sites activated with first patient dosing anticipated in 2Q 2026
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GAD: Voyage enrollment complete with 214 patients with topline data readout on track for early 3Q 2026; Panorama sample size re-estimation complete and target sample size updated to 200; screening closed with topline readout now expected in late 3Q 2026
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PTSD: DT120 ODT program expanded into PTSD with Phase 3 Haven study expected to initiate in 2027
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NEW YORK — Definium Therapeutics, Inc. (Nasdaq: DFTX) (“Definium” or the “Company”), a late-stage clinical biopharmaceutical company developing a new generation of therapeutics intended to address the underlying causes of psychiatric and neurological disorders, today highlighted the advancement of its DT120 ODT (lysergide tartrate) clinical program and commercial strategy in major depressive disorder (MDD) and generalized anxiety disorder (GAD), with three anticipated topline readouts in the next six months serving as important near-term catalysts. The Company also announced an expansion of the DT120 ODT program with the planned initiation of the Phase 3 Haven study in posttraumatic stress disorder (PTSD).
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“We are building Definium to be a leader in psychiatry, focused on delivering a differentiated, scalable franchise for patients with depression, anxiety, and trauma, anchored by DT120 ODT, which we believe could be a best-in-class therapy,” said Rob Barrow, Chief Executive Officer of Definium Therapeutics. “With three pivotal readouts expected over the next six months, we are rapidly establishing comprehensive clinical evidence for DT120 ODT. Together, these trial outcomes will inform our regulatory approach, including an expeditious path to a potential NDA submission. We continue to execute with focus and urgency to deliver transformative treatments for patients and sustained value for shareholders.”
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The Company is preparing for its next phase of growth with the same rigor and discipline that have underpinned the clinical development of DT120 ODT, which represents a potential multi-billion-dollar commercial opportunity supported by a differentiated therapeutic profile and broad applicability across care settings. Definium is advancing a focused, patient-centric commercial strategy, including a scalable delivery model designed to support efficient adoption and long-term utilization. In parallel, the Company is proactively positioning for access and reimbursement with plans to leverage established and emerging practice patterns and existing administrative pathways to enable timely market uptake.
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Clinical Advancements
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DT120 ODT (lysergide tartrate) for MDD
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- Emerge: Fully enrolled with 149 participants randomized 1:1 to receive DT120 ODT 100 µg or placebo. Topline data on track for late 2Q 2026.
- Ascend: Sites activated with first dosing anticipated in 2Q 2026. Study plans to enroll 175 participants randomized 2:1:2 to DT120 ODT 100 µg, DT120 ODT 50 µg control, or placebo.
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DT120 ODT (lysergide tartrate) for GAD
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- Voyage: Fully enrolled with 214 participants randomized 1:1 to receive DT120 ODT 100 µg or placebo. Topline data on track for early 3Q 2026.
- Panorama: Blinded sample size re-estimation complete with total target enrollment updated to 200 participants. Current enrollment over 200 participants and screening now closed. Participants randomized 2:1:2 to receive DT120 ODT 100 µg, DT120 ODT 50 µg control, or placebo. Topline data now anticipated in late 3Q 2026 (updated from 2H 2026).
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DT120 ODT (lysergide tartrate) for PTSD
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- Haven: Phase 3 study in PTSD expected to enroll approximately 200 participants randomized 1:1 to receive DT120 ODT or placebo. Primary endpoint in the study is the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) at Week 8. Study initiation expected in 2027.
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Today’s Investor and Analyst Day featured Definium’s executive leadership team alongside distinguished expert clinicians, who discussed the evolving treatment landscape in psychiatry, persistent unmet need, and emerging opportunities to improve outcomes for patients, as well as the Company’s clinical progress and commercial strategy. Presentation materials from today’s event are available here.
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About DT120 (lysergide tartrate) Orally Disintegrating Tablet (ODT)
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DT120 ODT is an ergoline derivative belonging to the group of classic serotonergic psychedelics, which acts as a partial agonist at serotonin-2A (5-HT2A) receptors. DT120 ODT is Definium’s proprietary and pharmaceutically optimized formulation of LSD. DT120 ODT is an advanced formulation incorporating Catalent’s Zydis® ODT fast-dissolve technology, designed to deliver several unique advantages, including faster absorption and onset of transient cognitive, perceptual, and affective changes, improved bioavailability, and a lower incidence of gastrointestinal side effects. Definium is developing DT120 ODT, the tartrate salt form of lysergide, for generalized anxiety disorder (GAD), major depressive disorder (MDD), posttraumatic stress disorder (PTSD), and is exploring its potential applications in other serious brain health disorders. Definium maintains a strong foundation to protect and extend the long-term value of the DT120 ODT franchise through a multi-layered intellectual property strategy spanning composition, formulation, and methods-of-use patents.
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