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Recent Updates — DFTX

September 14, 2026View Source ↗

Definium Therapeutics announced positive topline results from the Phase 3 Panorama study of DT120 ODT for generalized anxiety disorder (GAD). The trial met its primary endpoint, showing a placebo-adjusted reduction of 5.1 points in Hamilton Anxiety Rating Scale scores at Week 12 (p<0.0001) and significant improvements in key secondary endpoints. This marks the third positive Phase 3 readout for DT120 ODT, following successful studies in GAD and major depressive disorder. The company plans a pre-NDA meeting with the FDA in the fourth quarter of 2026 and anticipates filing a New Drug Application in the first half of 2027. Definium Therapeutics is a late-stage clinical biopharmaceutical company developing psychedelic-inspired therapeutics for psychiatric disorders.

September 8, 2026View Source ↗

On September 8, 2026, Definium Therapeutics announced that the U.S. Food and Drug Administration granted Breakthrough Therapy designation for its DT120 ODT program to treat major depressive disorder (MDD). This is the second such designation for DT120, following an earlier grant for generalized anxiety disorder. The FDA decision was supported by Phase 3 Emerge study results showing a statistically significant 8.1-point placebo-adjusted improvement in MADRS scores at Week 6 with durable efficacy through Week 12 after a single 100 µg dose. Definium Therapeutics is a late-stage clinical biopharmaceutical company developing psychedelic-inspired therapeutics for psychiatric and neurological disorders.

June 24, 2026View Source ↗

Definium Therapeutics, Inc. entered into an underwriting agreement on June 23, 2026, for a public offering of 20,588,236 common shares at $34.00 per share. Underwriters J.P. Morgan Securities LLC, Jefferies LLC, Leerink Partners LLC, and BofA Securities, Inc. fully exercised an option to purchase an additional 3,088,235 shares on June 24, 2026. The company expects gross proceeds of approximately $805 million and net proceeds of approximately $758 million. Net proceeds are earmarked for research and development, potential commercialization of DT120 ODT, and general corporate purposes. The offering is expected to close on June 25, 2026. Definium Therapeutics, Inc. is a biotechnology company focused on product candidate development.

June 22, 2026View Source ↗

Definium Therapeutics, Inc. announced positive topline data from its Phase 3 Emerge study of DT120 ODT for the treatment of major depressive disorder. The company released a press release and a presentation discussing the results of the study. Definium Therapeutics, Inc. is a biotechnology company focused on developing therapeutic solutions for mental health disorders.

June 12, 2026View Source ↗

On June 11, 2026, Definium Therapeutics, Inc. held its Annual General and Special Meeting of Shareholders. Shareholders approved an amendment to the 2025 Equity Incentive Plan, increasing the number of common shares available for issuance by 5,000,000. Additionally, shareholders elected seven directors to serve until the 2027 annual meeting and appointed KPMG LLP as the independent registered public accounting firm. The company operates in the biotechnology industry, focusing on the development of therapeutics.