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Definium's Phase 3 Depression Drug Hits Primary Endpoint, Shares Surge

6/22/2026

Summary

Definium Wins Trial

Definium Therapeutics said its Phase 3 trial of DT120 met the primary endpoint with an 8.1-point score reduction.
The single-dose oral-disintegrating tablet provided rapid, robust, durable relief for major depressive disorder.
Definium reported that 99% of adverse events were mild to moderate and lasted only the dosing day.
The company will use the data to pursue an FDA submission for major depressive disorder.
Definium’s share price rose to $4.50.

Summary

Definium Secures Breakthrough

Definium's DT120 secured FDA Breakthrough Therapy Designation, which may accelerate its regulatory review.
Definium reported $411.6 million in cash, giving runway through 2028, while analysts at Jefferies, RBC Capital, Canaccord Genuity and LifeSci Capital maintain Buy ratings with a $38 consensus target.
Definium’s market capitalization rose to about $2.67 billion as the Nasdaq advanced 1.9% and the S&P 500 climbed 1.1%.
Compass Pathways also experienced share-price gains, indicating sector-wide momentum for psychedelic-based medicines.

Summary

Trump Accelerates Psychedelics

President Donald Trump signed an executive order last year directing agencies to accelerate psychedelic mental-health therapy development.
Definium, rebranded from MindMed, is testing DT120 for PTSD and generalized anxiety disorder in Phase 3 trials while also evaluating an MDMA formulation for autism spectrum disorder.
The FDA placed psychedelics on its priority list as Compass Pathways announced a second positive Phase 3 trial of its COMP360 psilocybin therapy for treatment-resistant depression.

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Definium Wins Trial

Definium Therapeutics said its Phase 3 trial of DT120 met the primary endpoint with an 8.1-point score reduction.
The single-dose oral-disintegrating tablet provided rapid, robust, durable relief for major depressive disorder.
Definium reported that 99% of adverse events were mild to moderate and lasted only the dosing day.
The company will use the data to pursue an FDA submission for major depressive disorder.
Definium’s share price rose to $4.50.

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