Definium Targets First-Half 2027 NDA for DT120 ODT, Sees Runway Into 2030

Definium Therapeutics said Nov. 9 it remains on track to file a New Drug Application for DT120 ODT in the first half of 2027, with funds expected to support operations into 2030.

As of Sept. 30, the company held $241.150 million in cash and cash equivalents and $805.698 million in short-term investments, totaling $1.046848 billion. Definium’s runway estimate is based on its current operating plan and anticipated milestones. The company cautioned that actual results could vary materially.

DT120 ODT is based on lysergide D-tartrate and is being studied for generalized anxiety disorder and major depressive disorder; Definium plans to begin a Phase 3 study for post-traumatic stress disorder in 2027. Definium has yet to earn revenue or bring a product candidate to market.

“Our positive Phase 3 topline results from Voyage and Panorama this quarter further strengthened the evidence supporting DT120 ODT,” CEO Rob Barrow said.

Definium’s filing target remains the first half of 2027.