Mentioned:
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The United States Food and Drug Administration has just granted a new Breakthrough Therapy Designation to a LSD based drug. And a publicly traded company is behind it.

What’s happening:

  • Definium Therapeutics (NASDAQ: DFTX) has been awarded a Breakthrough Therapy Designation by the United States Food and Drug Administration for their LSD based novel therapeutic DT120 for depression

Why it matters:

  • This is the first time ever that the United States Food and Drug Administration has given a Breakthrough Therapy Designation to a publicly traded company developing an LSD based novel therapeutic for treating depression

Going deeper:

  • Definium Therapeutics recently published results from their Phase III clinical trial for DT120 which validated that a single dose led to significant improvement in patients with major depressive disorder compared to placebo and the benefits lasted for roughly 12 weeks
  • Definium Therapeutics was notably previously awarded a Breakthrough Therapy Designation for DT120 for treating generalized anxiety disorder

The intrigue: