Definium Therapeutics Reaches ~80% GAD Enrollment, Q2–Q3 2026 Readouts
Definium Therapeutics reports Voyage GAD trial ~80% enrolled with data due Q3 2026, Emerge MDD fully enrolled for late Q2 2026 readout and H2 2026 top-line Panorama under FDA Breakthrough alignment. The company reported a $183.8M net loss in 2025 and holds $411.6M cash to fund operations through 2028.
1. Pivotal Phase III Readouts
Voyage, the generalized anxiety disorder study of DT120 ODT, is approximately 80% enrolled with top-line data expected early Q3 2026. Emerge, the major depressive disorder trial, is fully enrolled with a late Q2 2026 readout, while the Panorama study is progressing quickly for H2 2026 results.
2. Financial Overview
During 2025 Definium invested $117.7 million in R&D and $48.6 million in G&A, resulting in a $183.8 million net loss. The company ended the year with $411.6 million in cash and investments, projected to support operations through 2028.
3. FDA Breakthrough and Trial Powering
Definium has secured FDA Breakthrough Therapy alignment to streamline future NDA submissions contingent on positive outcomes. A blinded sample-size re-estimation for Voyage observed a model-based standard deviation of 6.7 (versus 10 assumed), implying over 99% power to detect the planned five-point treatment difference.
4. DT-402 Autism Study Initiation
Beyond DT120, Definium initiated a phase IIa study of DT-402 in autism spectrum disorder in late 2025 and has dosed its first participant. Initial open-label data on core social communication endpoints are expected later in 2026.