Definium Therapeutics, Inc. 8K

Definium Therapeutics received FDA Breakthrough Therapy designation for its DT120 (lysergide) ODT for major depressive disorder, its second such designation for this program following generalized anxiety disorder.

Definium Therapeutics, Inc. announced that the U.S. Food and Drug Administration has granted Breakthrough Therapy designation to DT120 (lysergide) orally disintegrating tablet for the treatment of major depressive disorder, based on significant unmet need and positive Phase 3 Emerge study results showing a statistically significant 8.1‑point placebo‑adjusted improvement in MADRS total score at Week 6 with durable efficacy through Week 12; this is the second Breakthrough Therapy designation for DT120, which was previously designated for generalized anxiety disorder, reinforcing the program’s potential across multiple serious psychiatric indications and supporting the company’s psychedelic-derived drug development strategy and intellectual property franchise.

Filing Facts

CIK

1813814

Ticker

DFTX

Form

8K

Source Type

fda

Accession

0001193125-26-384403

Alert Tier

6