Definium Therapeutics Reports $51.0 Million Q3 Net Loss and DT120 Phase 3 Progress

Definium (DFTX) reported Q3 2026 earnings, highlighting FDA breakthrough therapy designations for DT120. The company plans an NDA filing in H1 2027 and shared positive clinical data for DT120 and DT402. DT120 showed significant improvements in anxiety and depression trials, with plans to expand into PTSD. DT402 showed early promise in autism spectrum disorder studies. The company is preparing for a potential launch, focusing on commercial infrastructure and provider engagement.

Definium Therapeutics (DFTX) reported Q3 earnings, highlighting progress in clinical trials for DT120 and DT402. DT120 showed tolerability in Phase 3 studies, with top-line results for Ascend expected in 2027. DT402's early autism study was halted after five participants showed consistent efficacy signals. R&D expenses rose to $46.1M, with a net loss of $51M, narrower than the previous year. The company plans commercial preparations for DT120, targeting a pricing range of $30,000-$75,000.

Definium Therapeutics (DFTX) shares rose 0.2% after reporting Q3 2026 results. The company narrowed its net loss to $50.96M, reported positive Phase 3 results for DT120 ODT in anxiety, and received FDA Breakthrough Therapy Designation for depression. Cash reserves increased to $1.05B. Analysts maintain a Buy consensus with raised price targets.

Definium Therapeutics, Inc. (DFTX) filed an SEC Form 8-K — Results of Operations and Financial Condition. Exhibit 99.1 Definium Therapeutics Reports Third Quarter 2026 Financial Results and Recent Highlights Reported positive topline Phase 3 results from two Phase 3 studies of DT120 ODT in generalized anxiety disorder (GAD) Received FDA Breakthrough Therapy Designation for DT120 ODT

Definium Therapeutics (DFTX) will present positive topline data from three Phase 3 studies of DT120 ODT for generalized anxiety disorder (GAD) and major depressive disorder (MDD) at the 2026 NEI Fall Congress. The studies, Panorama, Emerge, and Voyage, showed efficacy and safety, with DT120 ODT receiving FDA Breakthrough Therapy designation for GAD and MDD. The presentations will include comprehensive safety data and support continued clinical assessment.

RBC Capital reiterated an Outperform rating for Definium Therapeutics (DFTX) with a $66 price target, citing strong Phase III trial data for anxiety and depression treatments. Despite a 30% share price drop, RBC sees potential for approval and $2.5B peak revenue. Other analysts also raised price targets following positive trial results.