Definium Therapeutics, Inc. 8K

Definium Therapeutics reported positive, registration-supportive Phase 3 Panorama topline results for DT120 ODT in generalized anxiety disorder and outlined its plan to file an NDA in 2027 and pursue a large commercial opportunity with substantial existing cash runway.

Definium Therapeutics, Inc. furnished an investor presentation as Exhibit 99.2 providing topline results from its Phase 3 Panorama study of DT120 ODT 100 µg, a proprietary lysergide tartrate orally disintegrating tablet, in generalized anxiety disorder, reporting that the trial met all primary and key secondary endpoints with highly statistically significant and clinically meaningful improvements on the Hamilton Anxiety Rating Scale and Clinical Global Impression–Severity, a favorable safety and tolerability profile with mostly mild-to-moderate, on‑dose‑day adverse events, and session durations supporting scalable clinical use; the company highlighted alignment of these data with prior Phase 2b dose–response models and other late‑stage trials, reiterated its regulatory strategy including a pre‑NDA meeting in 4Q 2026 and an anticipated NDA filing in 1H 2027 for DT120 ODT in GAD and MDD, and outlined the potential commercial opportunity, estimated multi‑billion‑dollar revenue potential at modest penetration, and a cash runway extending into 2030 to support continued development and commercialization preparations.

Filing Facts

CIK

1813814

Ticker

DFTX

Form

8K

Source Type

fda

Accession

0001104659-26-107275

Alert Tier

7