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Definium begins second Phase 3 trial for DT120

Story Highlights
  • Definium has begun dosing in Ascend, its second Phase 3 trial of DT120 ODT for major depressive disorder, aiming to enroll 175 U.S. patients and measure MADRS score changes against placebo.
  • The Ascend study’s design, aligned with Definium’s broader DT120 program and prior GAD data, seeks to validate an LSD-based, serotonergic psychedelic therapy as a differentiated treatment in the high-need depression and anxiety market.
  • Looking for the best stocks to buy? Follow the recommendations of top-performing analysts.
Definium begins second Phase 3 trial for DT120

Meet Samuel – Your Personal Investing Prophet

Definium Therapeutics ( (DFTX) ) just unveiled an update.

On May 12, 2026, Definium Therapeutics announced that it had dosed the first patient in Ascend, its second Phase 3 pivotal trial of DT120 Orally Disintegrating Tablet for major depressive disorder, a study that will enroll 175 U.S. participants and assess changes in Montgomery-Åsberg Depression Rating Scale scores at Week 6 versus placebo. The trial, structured with a 12-week double-blind phase followed by a 40-week open-label extension, aligns with the company’s broader DT120 program in depression and anxiety, underscoring Definium’s bid to position its LSD-derived therapy as a differentiated option in a large, high-unmet-need market for mood disorders.

Ascend’s design, which includes both 100 µg and 50 µg DT120 doses alongside placebo, is intended to address functional unblinding concerns and build on prior Phase 2b results in generalized anxiety disorder that suggested antidepressant effects, reinforcing the scientific rigor behind Definium’s psychedelic-based approach. With topline data from the 12-week double-blind period expected in 2027 and another Phase 3 MDD study, Emerge, approaching a readout, the company is entering a critical development phase that could significantly influence its clinical trajectory and competitive standing in the emerging psychedelic therapeutics sector.

The most recent analyst rating on (DFTX) stock is a Buy with a $38.00 price target. To see the full list of analyst forecasts on Definium Therapeutics stock, see the DFTX Stock Forecast page.

Spark’s Take on DFTX Stock

According to Spark, TipRanks’ AI Analyst, DFTX is a Neutral.

The score is held back primarily by weak financial performance (no revenue, large and widening losses, and persistent cash burn), partially offset by solid balance sheet positioning (no debt and substantial cash runway). Technicals are supportive with a strong longer-term uptrend and positive momentum. The earnings call points to meaningful near-term clinical catalysts and strong liquidity, but elevated spending and execution/regulatory/payer risks remain material.

To see Spark’s full report on DFTX stock, click here.

More about Definium Therapeutics

Definium Therapeutics, Inc. is a late-stage clinical biopharmaceutical company developing a new generation of therapeutics aimed at the underlying causes of psychiatric and neurological disorders. The New York-headquartered company’s lead program, DT120 Orally Disintegrating Tablet, is a proprietary LSD-based formulation being advanced for conditions including major depressive disorder, generalized anxiety disorder and posttraumatic stress disorder, supported by a multi-layered intellectual property strategy.

Average Trading Volume: 1,768,077

Technical Sentiment Signal: Strong Buy

Current Market Cap: $2.4B

See more insights into DFTX stock on TipRanks’ Stock Analysis page.

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