Definium Therapeutics, Inc. filed a Form 8-K with the SEC on August 12, 2026, disclosing positive topline data from its Phase 3 Voyage study of DT120 ODT for the treatment of generalized anxiety disorder.

Key Highlights

  • Phase 3 results announced: The company reported positive topline data from the Phase 3 Voyage study of DT120 ODT for generalized anxiety disorder.
  • Press release issued: A press release announcing the topline data was issued on August 12, 2026, and is attached as Exhibit 99.1.
  • Investor presentation posted: A Voyage topline data presentation was posted to the company's website on August 12, 2026, and is attached as Exhibit 99.2.
  • Emerging growth company: The registrant indicated it qualifies as an emerging growth company under applicable SEC rules.
  • Signed by CEO: The filing was signed by Robert Barrow, Chief Executive Officer, on August 12, 2026.

Definium Therapeutics Discloses Phase 3 Voyage Study Results for DT120 ODT

Definium Therapeutics, Inc. (NASDAQ:DFTX), incorporated in British Columbia and headquartered at One World Trade Center, Suite 8500, New York, New York 10007, filed a current report on August 12, 2026, disclosing topline results from its Phase 3 Voyage study. According to the filing, the company issued a press release on that date "announcing positive topline data from the Company's Phase 3 Voyage study of DT120 ODT for the treatment of generalized anxiety disorder."

The disclosure was made under Item 7.01 (Regulation FD Disclosure) and Item 8.01 (Other Events). The filing notes that the information furnished under Item 7.01, including the press release attached as Exhibit 99.1, "shall not be deemed to be 'filed' for purposes of Section 18 of the Securities Exchange Act of 1934, as amended." In addition to the press release, the company disclosed that it posted a presentation discussing the Voyage topline data to its website, attached as Exhibit 99.2.

The filing was signed by Chief Executive Officer Robert Barrow on behalf of Definium Therapeutics, Inc. The company confirmed its status as an emerging growth company, as defined under Rule 405 of the Securities Act of 1933 and Rule 12b-2 of the Securities Exchange Act of 1934, and indicated it has not elected to use the extended transition period for complying with new or revised financial accounting standards.

What Was Disclosed

Definium Therapeutics filed an 8-K on August 12, 2026, reporting positive topline data from its Phase 3 Voyage study of DT120 ODT for generalized anxiety disorder, accompanied by a press release and an investor presentation posted to its website.