Definium Therapeutics

Definium Therapeutics shares climbed 20.7% in premarket trading after the phase‑3 study “Panorama” for DT120 ODT (Lysergid/LSD) in adults with generalized anxiety disorder met its primary endpoint. At week 12 the placebo‑corrected reduction on the HAM‑A scale was 5.1 points, with a highly significant p‑value and an effect size of 0.64. The results follow an earlier positive phase‑3 outcome (Voyage) and the recently granted FDA breakthrough therapy designation for DT120 in MDD, prompting numerous analysts to issue buy ratings. Investors are now focused on approval timelines and DT120’s potential as a first‑in‑class therapy for GAS and MDD. » Mere på de.investing.com

The Phase‑3 Voyage study showed that DT120 ODT (pharmaceutically optimized LSD formulation) met the primary endpoint and all key secondary endpoints in generalized anxiety disorder, with a statistically significant reduction in HAM‑A score and a higher response rate versus placebo. Treatment was generally well tolerated; adverse events were mild to moderate and mostly occurred on the day of dosing. This is the second positive Phase‑3 readout following the Emerge depression results; further Panorama data are expected in September 2026. According to the company, Definium holds roughly $1.1 billion in cash and views its financing as secured through 2030. » Mere på finanzen.net

Definium Therapeutics' stock last traded near its 52-week high of $47.01 and is currently at $47.20, after rising 613.41% over the past year. The company raised $805 million via a guaranteed capital increase (sale of 23,676,471 common shares at $34.00), and plans a separate offering of common shares and pre-funded warrants totaling $500 million. Needham raised its price target to $50.00 and reiterated a "Buy" rating following promising EMERGE data for treating major depression, while InvestingPro warns of potential overvaluation and high volatility (beta 2.38). » Mere på de.investing.com