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Definium Therapeutics Receives FDA Breakthrough Therapy Designation For DT120 ODT; Second Breakthrough Therapy Designation For DT120 Reinforces Its Potential Across MDD And Generalized Anxiety Disorder

Sep 8, 2026 · 07:08 AM ET· updated 1h ago

The designation was supported by the significant unmet medical need in MDD and results from the Company's Phase 3 Emerge study, in which a single 100 µg dose of DT120 ODT demonstrated a statistically significant

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Why It Matters

Definium's medicine for depression and anxiety got special fast-track approval from the FDA, which means doctors and scientists think it could really help people. When a company gets this kind of official thumbs-up, it shows their medicine is promising, so it's worth watching how the testing goes.

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Source: Benzinga · Read the original report at the publisher. Headline and figures shown for context; data may be delayed.

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