Biotech company Definium announced the success of its LSD drug trials. What are the prospects?

Shares of biotech company Definium Therapeutics—one of the players in the psychedelic-based medicine market—rose 3.5% at the close of trading on Monday, September 14. The company reported positive results from a late-stage study of an LSD pill in patients with generalized anxiety disorder and announced plans to file for regulatory approval of the drug. The company’s stock has already tripled in price since the beginning of 2026.

Definium Therapeutics' stock price rose 3.5% on the Nasdaq on September 14, reaching $40.25. In premarket trading on September 15, it gained another 1.2% or so.

The company announced positive results from a Phase 3 trial of DT120, a drug intended for the treatment of mental disorders. As part of the trial, the company evaluated the drug’s efficacy in patients with generalized anxiety disorder. This marks the second success in Phase 3 trials of this drug specifically for this condition and the third overall—following its success in trials for major depressive disorder (clinical depression).

Definium describes DT120 as a patented and pharmaceutically optimized formulation of the psychedelic LSD, which temporarily alters perception, cognitive processes, and emotional state.

The DT120 study, codenamed Panorama, has achieved its primary objective, according to Definium: the drug performed twice as well as the placebo on the Hamilton Anxiety Scale —a clinical tool used to assess the severity of anxiety symptoms. According to the company’s data, 12 weeks after the start of treatment, this score improved by an average of 9.8 points on the 56-point HAM-A scale. In the placebo group, the improvement was only 4.7 points. Definium notes that the drug acted quickly: an improvement in the patients’ condition was observed as early as the second day after treatment began.

A key feature of the DT120 is that a single dose can potentially maintain its effect for several months, freeing patients from the need to take pills every day, said Scott Aaronson, scientific director of the Institute for Advanced Diagnostics and Therapeutics at Sheppard Pratt, who participated in the study (his comments are cited in the Definium press release). Existing medications for patients with generalized anxiety disorder are difficult to match to individual patients, and they must be taken daily, which creates an additional burden—including weight changes, sedative effects, and the potential for dependence, Aaronson noted.

Following a series of successful trials, Definium intends to submit a marketing application for the drug to the U.S. Food and Drug Administration (FDA) in the first half of 2027. A meeting with the FDA is already scheduled for the fourth quarter of this year.

The U.S. Drug Enforcement Administration (DEA) currently classifies LSD—lysergic acid diethylamide—as a substance with no recognized medical use and a high potential for abuse.

However, this classification may change: in April 2026, President Donald Trump signed an executive order aimed at accelerating patients’ access to treatment for severe mental illnesses. Following this, the FDA announced a series of supporting regulatory measures, including the release of guidelines for the development of “psychedelic drugs”—specifically, substances that act on serotonin 2A receptors and alter perception. LSD also belongs to this class.

The trial results exceeded Wall Street’s expectations, noted RBC Capital Markets analyst Brian Abrahams, as quoted by Barron’s. According to the expert, Definium’s latest data could significantly reduce regulatory risks, unlock substantial growth potential for the company, and enable it to submit an application for approval of the drug for two indications at once: generalized anxiety disorder and major depressive disorder.

Since the beginning of the year, Definium’s stock has surged 200%. All 18 Wall Street analysts tracking the company have issued a “buy” recommendation (all “Buy” ratings, except for one “Overweight” rating—“above market”), according to MarketWatch. The average price target is $71.59—78% higher than the closing price on September 14.

This article was AI-translated and verified by a human editor