Common Shares
- Symbol
- DFTX
- Exchange
- NASDAQ
- Classification
- COMMON
- Status
- Current
Current Report · Items 7.01, 8.01, 9.01 · 8-K
Definium Therapeutics, Inc.
DFTXNASDAQEQUITYCurrent
Regulation FD Disclosure · Other Events
Item 7.01 Regulation FD Disclosure. On August 12, 2026, Definium Therapeutics, Inc. (the “Company”) issued a press release (the “Press Release”) announcing positive topline data from the Company’s Phase 3 Voyage study of DT120 ODT for the treatment of generalized anxiety disorder. A copy of the Press Release is attached as Exhibit 99.1 hereto, and is incorporated by reference into this Item 8.01.…
Company context
The mission of Definium Therapeutics is to forge a new era of psychiatry by applying scientific rigor to psychedelics, with the goal of developing accessible treatments that unlock healing at scale. Guided by a recognition that patients deserve more than better, Definium is relentlessly advancing a new generation of therapeutics intended to address underlying causes of psychiatric and neurological disorders. By turning evidence into impact, Definium aims to change the trajectory of today's mental health care crisis and enable a healthier future. Headquartered in New York, Definium Therapeutics trades on Nasdaq under the symbol DFTX.
Current securities
Registered securities in this filing
Definium Therapeutics, Inc. · 8-K · Filed 2026-08-12
Disclosure sections
Item 7.01Item 7.01 - Regulation FD Disclosure
Item 7.01 Regulation FD Disclosure.
On August 12, 2026, Definium Therapeutics, Inc. (the “Company”)
issued a press release (the “Press Release”) announcing positive topline data from the Company’s Phase 3 Voyage study
of DT120 ODT for the treatment of generalized anxiety disorder. A copy of the Press Release is attached as Exhibit 99.1 hereto, and is
incorporated by reference into this Item 8.01.
The information furnished pursuant to this Item 7.01, including Exhibit
99.1, shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the
“Exchange Act”), or otherwise subject to the liabilities of that Section, nor shall it be deemed to be incorporated by reference
into any of the Company’s filings with the SEC under the Exchange Act or the Securities Act of 1933, as amended, whether made before
or after the date hereof, regardless of any general incorporation language in such a filing, except as expressly set forth by specific
reference in such a filing.
Item 8.01Item 8.01 - Other Events
Item 8.01 Other Events.
On August 12, 2026, the Company posted a presentation discussing the
Voyage topline data (the “Presentation”) to its website. A copy of the Presentation is attached as Exhibit 99.2 hereto, and
is incorporated by reference into this Item 8.01.
Filed exhibits (2)
EX-99.1 2 tm2622948d1_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 Definium Therapeutics Announces Positive Topline Results from Phase 3 Voyage Study of DT120 ODT in Generalized Anxiety Disorder Study met primary and all key secondary efficacy endpoints Participants receiving DT120 ODT achieved a statistically significant reduction in Hamilton Anxiety Rating Scale (HAM-A) score, with a placebo-adjusted change of 5.4 points from baseline at Week 12 (p<0.0001, Cohen’s d=0.81) DT120 ODT was generally well tolerated, with a safety profile consistent with prior clinical experience Company to host webcast today at 8:00 am EDT NEW YORK-- (BUSINESS WIRE) -- Definium Therapeutics, Inc. (Nasdaq: DFTX) ("Definium" or the "Company"), a late-stage clinical biopharmaceutical company developing a new generation of therapeutics intended to address underlying causes of psychiatric and neurological disorders, today announced positive topline results from Voyage, its first Phase 3 study of DT120 (lysergide) Orally Disintegrating Tablet (ODT) 100 µg in adults with generalized anxiety disorder (GAD). The results mark the Company’s second positive DT120 ODT Phase 3 readout, following the positive Emer…
Open exhibit ↗EX-99.2 3 tm2622948d1_ex99-2.htm EXHIBIT 99.2 Exhibit 99.2 Phase 3 Voyage Study Topline Data Readout This presentation (the “Presentation”) has been prepared by Definium Therapeutics, Inc. (“Definium”, the “Company”, “we”, “ou r” or “us") solely for informational purposes. This Presentation does not constitute an offering of, or a solicitation of an off er to purchase, securities of Definium and under no circumstances is it to be construed as a prospectus or advertisement or public offering of securitie s. Any trademarks included herein are the property of the owners thereof and are used for reference purposes only. Such use shou ld not be construed as an endorsement of the products or services of Definium. Any amounts are in USD unless otherwise noted. Definium’s securities have not been approved or disapproved by the U.S. Securities and Exchange Commission (the "SEC") or by any state, pr ovincial or other securities regulatory authority, nor has the SEC or any state, provincial or other securities regulatory authority passed on the accurac y o r adequacy of this Presentation. Any representation to the contrary is a criminal offense. Cautionary Note Regarding Forward - Looki…
Open exhibit ↗