Topline Data from Three Phase 3 Studies Evaluating DT120 Orally Disintegrating Tablet (ODT) for GAD and MDD Expected in 2026: Voyage in 2Q, Panorama in 2H, and Emerge Mid-Year

Definium Therapeutics, Inc. unveiled its new brand , marking a decisive step forward as the company leads psychiatry toward a transformation built on strong clinical evidence, scientific rigor, and the ambition to evolve the treatment paradigm for mental health. Definium is developing innovative, next-generation therapeutics intended to solve the underlying causes of psychiatric and neurological disorders and offer patients long-term remission rather than transient symptom reduction.

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Over the past several years, the Company has offered a clear, differentiated vision and executed with discipline, positioning it as a leader in psychiatric drug development. Definium Therapeutics demonstrates this clarity and consistency, representing a confident step forward that best reflects what the Company has become and the enormous potential of what it’s building for tomorrow.

“Definium Therapeutics reflects the core of who we’ve always been and where we’re headed – disciplined execution, scientific leadership, and a vision to develop accessible treatments that can unlock healing at scale,” said Rob Barrow, Chief Executive Officer of Definium Therapeutics. “We are unwavering in our mission to forge a new era of psychiatry by applying scientific rigor to psychedelics. By retracing LSD to its origins, we aim to fully realize its clinical potential as a safe and transformative therapeutic. With three Phase 3 readouts expected in 2026, we are uniquely positioned to validate the strength of our science, advance care for patients, and continue delivering long-term value for our shareholders.”

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2026 Anticipated Milestones & Events

Definium is set to deliver some of the psychiatric field’s most important data in 2026, highlighting its progress and ambition to bring novel, scalable therapies to patients underserved by standard of care. The Company plans to advance DT1201 ODT toward FDA submissions in the two largest psychiatric markets—generalized anxiety disorder (GAD) and major depressive disorder (MDD)—which together affect over 50 million people2 in the U.S.

Definium’s late-stage pipeline includes four Phase 3 trials—two each for GAD and MDD—anchored by its lead candidate, DT120 ODT, which has received FDA Breakthrough Therapy Designation for GAD.

In parallel, the Company is advancing its commercial strategy and operational readiness to support a best-in-class care model and prepare for the potential launch of DT120 ODT, if approved and marketed. Definium also continues to advance its early-stage pipeline, having dosed the first patient in a Phase 2a study of DT4023 in adults with autism spectrum disorder (ASD).

Expected this year:

  • 2Q 2026: Analyst Day highlighting pivotal programs, pipeline and path to commercialization
  • 2Q 2026: Topline data from Voyage – the first Phase 3 study of DT120 ODT in GAD
  • 2H 2026: Topline data from Panorama – the second Phase 3 study of DT120ODT in GAD
  • Mid-year 2026: Topline data from Emerge – the first Phase 3 study DT120 ODT in MDD
  • Mid-year 2026: Initiation of Ascend – the second Phase 3 study of DT120 ODT in MDD
  • 2026: Initial datafrom DT402 – early signs of efficacy study in ASD

“Definium Therapeutics marks a defining moment in our evolution as we move from shaping what’s possible in psychiatry to setting a new standard for what’s next,” said Stephanie Fagan, Chief Corporate Affairs Officer of Definium Theraeutics. “‘Definio’ speaks to our clear sense of direction and scientific precision, and ‘infinitum’ to being open to what hasn’t been done before and the impact we can have on the world. Together, they capture how Definium is moving psychiatry forward for patients and providers—guided by transparency, trust and collaboration with all our stakeholders—measured by the lives we hope to transform.”

In conjunction with the rebrand, the Company’s Nasdaq ticker symbol will change to “DFTX” effective at market open on January 13, 2026.

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Source- businesswire