RegulatoryCompany release

Definium's DT120 ODT hits primary goals in two Phase 3 anxiety trials

🇺🇸 Definium Therapeutics, Inc. (DFTX) · Mon 09 Nov 2026

The company also won FDA Breakthrough Therapy status for the drug in major depressive disorder and plans an NDA filing in the first half of 2027.

Definium Therapeutics said on 9 November 2026, alongside its third-quarter results, that two Phase 3 studies of DT120 ODT in generalized anxiety disorder met their primary endpoints. The studies are named Voyage and Panorama.

The US Food and Drug Administration has also granted Breakthrough Therapy designation to DT120 ODT for major depressive disorder. The company plans to submit a New Drug Application in the first half of 2027.

Definium additionally reported early Phase 2a results for DT402 in autism spectrum disorder. The summary available does not give detailed efficacy figures, dosing or safety data for either programme, so the size of the treatment effects and the tolerability profile cannot yet be assessed.

On the financial side, the company reported cash of about $1.05 billion, which it expects to fund operations into 2030.

For context, Breakthrough Therapy designation is an FDA process intended to speed the development and review of drugs for serious conditions where early clinical evidence suggests substantial improvement over existing treatments.

What it means for your team

  • Regulatory teams should note the planned NDA submission in the first half of 2027, which sets the timeline for an FDA review of DT120 ODT.
  • The Breakthrough designation in major depressive disorder may bring more frequent FDA interaction during development, which is a general feature of the programme.
  • Pharmacovigilance and market-access teams will need the full Phase 3 safety and efficacy data, not yet in the summary, to judge the benefit-risk profile and the likely commercial positioning.
  • The cash runway into 2030 suggests the company can fund the filing and review phase without needing near-term financing.

Company's press release (SEC filing): Definium Therapeutics, Inc. ↗

Article written by VigiEye from the official source (Definium Therapeutics, Inc.). Claims are the company's own. AI-assisted; check the source before acting.

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