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Definium Therapeutics Receives Breakthrough Therapy Designation for DT120 (lysergide) Orally Disintegrating Tablet (ODT) in Major Depressive Disorder (MDD) Following Positive Phase 3 Results

Key Takeaway: Definium Therapeutics has received Breakthrough Therapy designation from the FDA for its DT120 (lysergide) orally disintegrating tablet, aimed at treating Major Depressive Disorder (MDD). This designation highlights the significant unmet medical need in the MDD space. The decision is supported by positive results from Phase 3 clinical trials.

Market Sentiment Analysis

POSITIVE FACTORS

  • Breakthrough Therapy designation received from the FDA.
  • Significant unmet medical need in Major Depressive Disorder addressed.
  • Positive Phase 3 results bolster the drug's potential.

BiopharmaWatch Analysis

From our catalyst data and publicly available data · not financial advice
Cash runway
~61 mo
Minimal dilution risk
Lead asset
DT120
Phase 3 · Major Depressive Disorder

Full Press Release Details

NEW YORK--(BUSINESS WIRE)--Definium Therapeutics, Inc. (“Definium” or the “Company”), a late-stage clinical biopharmaceutical company developing a new generation of therapeutics intended to address underlying causes of psychiatric and neurological disorders, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for DT120 (lysergide) ODT. The designation was supported by the significant unmet medical need in MDD and results from the Company

Frequently Asked Questions

What is DT120?

DT120 is an orally disintegrating tablet containing lysergide, developed for treating Major Depressive Disorder.

What designation did DT120 receive?

DT120 received Breakthrough Therapy designation from the FDA.

Why was Breakthrough Therapy designation granted?

The designation was granted due to the significant unmet medical need in Major Depressive Disorder.

What were the results of the Phase 3 trials?

The Phase 3 trials for DT120 showed positive results, supporting its efficacy.

Last updated: Sep 8, 2026