First marijuana, then peptides-and now psychedelics are getting a second look, as Definium Therapeutics advances the case for medical LSD.

The drugmaker on Monday reported positive late-stage trial data for its fast-dissolving oral tablet, DT120, in patients with generalized anxiety disorder. The results marked the third positive Phase 3 readout for the drug this year and the second for anxiety specifically.

The trial met its main goal, showing significant improvement over placebo on the Hamilton Anxiety Rating Scale, a questionnaire gauging the severity of anxiety symptoms. It also met key secondary goals including improvement across two other clinician-rated scales.

Patients showed a 9.8-point improvement on the 56-point scale, called the HAM-A, 12 weeks after undergoing treatment. The placebo group, meanwhile, improved by just 4.7 points. Definium noted that the changes occurred rapidly, with improvement seen as early as the second day as treatment.

Shares rose 3.5% on Monday after spiking as much as 19% in premarket trading.

According to RBC Capital Markets analyst Brian Abrahams, the results appears to have exceeded Wall Street's expectations. The latest readout could reduce regulatory risk and unlock significant potential growth, "especially with the stock having pulled back into the results," he said.

Given the strength of the data to date across multiple well-designed studies, Abrahams believes Definium could file for approval for both generalized anxiety disorder and major depressive disorder.

Traditionally a party drug, LSD, or lysergic acid diethylamide, is currently classified as a Schedule I controlled substance, suggesting a high potential for abuse and no accepted medical use. Definium's DT120 contains a precise dose of lysergide D-tartrate, a salt form of LSD.

However, attitudes have been shifting towards drug's potential for decades, prompting a major re-evaluation in the medical community in the early 2000s.

Recent regulatory actions have also smoothed out the path ahead. President Donald Trump in April signed an executive order directing the Food and Drug Administration to accelerate access to treatments for patients with "serious mental illness," including complex and treatment-resistant conditions.

The directive placed psychedelic drugs directly in the regulatory line of sight. "The FDA subsequently announced a series of regulatory actions to support the development of what it called "perception-altering psychedelic medications," specifically serotonin-2A agonists, a class that includes LSD.

The directive aligns with a broader effort to overhaul drug regulations. Earlier this year, the Trump administration executed a radical shift in federal policy by reclassifying state-licensed marijuana as a less dangerous drug.

The administration has similarly championed popular therapeutic peptides, moving to ease restrictions and expand consumer access through compounding pharmacies despite safety warnings from scientists.

Altogether, these moves paint create a favorable backdrop for Definium. Jefferies analyst Andrew Tsai sees the narrative around DT120 "shifting to commercialization" following the latest readout, with potential approval by the end of next year.

Definium CEO Rob Barrow confirmed that the company was advancing toward a New Drug Application for DT120 and pointed to an upcoming meeting with regulators in the fourth quarter. Definium expects to file its application sometime in the first half of 2027.