DT120 is a Definium Therapeutics, Inc. program. Every date links its source.
All upcoming FDA decision dates on the 2026 PDUFA calendar
Sponsor: Definium Therapeutics, Inc. (DFTX). Review status: Definium Therapeutics announced positive topline results from the Phase 3 Panorama study of DT120 ODT in generalized anxiety disorder on September 14, 2026: the study met its primary and all key secondary efficacy endpoints (8-K exhibit 99.1). We track 1 catalyst event for this program: 0 upcoming and 1 in the record. A PDUFA date is the FDA's target date to complete review of a marketing application; a readout is the sponsor's expected date for clinical trial results. What a PDUFA date is · why we do not compare trial results across drugs.
| Fund | Shares | Value at quarter end | Filing |
|---|---|---|---|
| Avoro Capital Advisors | 7,188,888 | $338.2 million | filed August 14, 2026 |
| RA Capital Management | 1,500,000 | $70.6 million | filed August 14, 2026 |
| RTW Investments | 400,000 | $18.8 million | filed August 14, 2026 |
| Cormorant Asset Management | 400,000 | $18.8 million | filed August 14, 2026 |
| OrbiMed Advisors | 365,400 | $17.2 million | filed August 14, 2026 |
13F reports list long positions in common stock at quarter end, are due 45 days later, and show no short positions or later trades. Notes, warrants and other instruments are not counted as shares.
DT120's most recent tracked catalyst has already reported: positive data on Sep 14, 2026, per the company's own release (linked in the history below). No further catalyst is on our calendar yet.
No FDA decision for DT120 is in our archive yet.
Definium Therapeutics, Inc. (DFTX).
FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.