DFTX Stock Rallies Ahead Of High-Stakes Phase 3 Depression Drug Trial Results — What Investors Need To Know

Definium said it will host a webcast on Tuesday morning to discuss results from Emerge, a Phase 3 study evaluating DT120 ODT in adults with Major Depressive Disorder.

• Emerge is one of two pivotal Phase 3 studies evaluating DT120 ODT in adults with MDD, making the upcoming readout a key catalyst for the company.
• The trial enrolled 149 adults with MDD and is testing whether a single 100-microgram dose of DT120 ODT can significantly reduce depression symptoms compared with placebo.
• The primary endpoint is the change from baseline in Montgomery-Åsberg Depression Rating Scale scores at Week 6.

Shares of Definium Therapeutics Inc. (DFTX) soared nearly 12% in Monday’s pre-market trade as the company gears up to release topline results from its Phase 3 Emerge study in Major Depressive Disorder (MDD).

Definium said it will host a webcast on Tuesday at 8 a.m. EDT to discuss results from Emerge, a Phase 3 study evaluating DT120 ODT in adults with major depressive disorder.

DFTX’s Emerge Trial Details

Emerge is one of two pivotal Phase 3 studies evaluating DT120 ODT in adults with MDD, making the upcoming readout a key catalyst for the company.

The trial enrolled 149 adults with MDD and is testing whether a single 100-microgram dose of DT120 ODT can significantly reduce depression symptoms compared with placebo.

The primary endpoint is the change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) scores at Week 6.

Focus On DFTX’s Ascend Study, Too

Beyond Emerge, Definium is also conducting Ascend, a second pivotal Phase 3 study in MDD that includes both 100-microgram and 50-microgram dose arms.

The company has said the lower-dose arm is intended to help maintain blinding and build on findings from an earlier Phase 2b study in generalized anxiety disorder.

Definium said the design of its Ascend Phase 3 study builds on findings from a Phase 2b trial of DT120 in generalized anxiety disorder, which the company believes demonstrated that the drug's clinical activity was not driven by functional unblinding.

The company dosed the first patient in Ascend last month and expects the study to enroll approximately 175 participants in the U.S. Like Emerge, the trial's primary endpoint is the change from baseline in MADRS scores at Week 6.

MADRS is a clinician-administered questionnaire that measures the severity of depression symptoms, with lower scores indicating an improvement in a patient's condition.

What Retail Traders Think About DFTX Stock

Retail sentiment on Stocktwits around Definium Therapeutics trended in the ‘extremely bullish’ territory, with message volumes at ‘extremely high’ levels at the time of writing.

One user said that they’ve been waiting for this moment since the summer of 2020.

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DFTX stock is up 83% year-to-date and 245% over the past 12 months. The iShares Russell 2000 ETF (IWM) is up 41% over the past 12 months, while the Vanguard Extended Market Index Fund ETF (VXF) is up 29%.

The iShares Biotechnology ETF (IBB) is up 38% during this period, while the iShares Russell 2000 Value ETF (IWN) is up 41%.

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