Odyssey Therapeutics, Inc. ODTX
Odyssey Therapeutics, Inc. (Nasdaq: ODTX) is an immunology/inflammation drug developer. Its lead program, OD-001, is in Phase 2 for ulcerative colitis. Its next catalyst on record is OD-002: CTA filing outside the US (H2 2026).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: OD-002 — CTA filing outside the US (H2 2026). 7 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| OD-001 (RIPK2 scaffolding inhibitor) - phase 2a monotherapy | ulcerative colitis | small molecule | Phase 2 |
| OD-001 + vedolizumab combination (phase 2a) | ulcerative colitis | small molecule | Phase 2 |
| OD-002 (SLC15A4 inhibitor) | cutaneous lupus erythematosus / SLE / interferonopathies | small molecule | Pre-clinical |
| OD-003 (TNFR2 agonist V-body) | autoimmune/inflammatory (Treg expansion) | protein/peptide | Pre-clinical |
| OD-004 (TSLP/IL-33 bispecific V-body) | asthma / COPD | antibody | Pre-clinical |
| IRAK4 scaffolding inhibitor | inflammatory/autoimmune | small molecule | Pre-clinical |
| IRF5 inhibitor (with Terray) | autoimmune | small molecule | Pre-clinical |
Recent results and decisions
- Oct 20, 2026met Open-label Phase 2a induction met primary endpoint: mean 2.4-point reduction in modified Mayo score at Week 12 (p<0.001); clinical remission 27% at 20 mg BID (n=41) and 20% at 10 mg BID (n=15).
Induction (Week 12) efficacy: OD-001 met the trial’s primary endpoint of change from baseline in modified Mayo score at the end of induction at Week 12 (mean reduction of 2.4 points across the evaluable population; p<0.001).
Filing - Oct 20, 2026n/a Odyssey plans to initiate a randomized, placebo-controlled Phase 2b monotherapy trial and an active-controlled Phase 2a combination trial evaluating OD-001 plus vedolizumab.
Odyssey plans to advance OD-001 into a randomized, placebo-controlled Phase 2b monotherapy trial and a randomized, active-controlled Phase 2a trial evaluating OD-001 plus vedolizumab versus vedolizumab plus placebo.
Filing - Sep 9, 2026positive Corporate presentation shows consolidated Phase 2a OD-001 UC data (49 patients completing 12 weeks), with clinical remission placebo-adjusted deltas of 16 points in AT-naive (n=33) and 22 points in AT-experienced (n=16) patients; data subject to change before database lock.
Concordant efficacy measures across all endpoints, consistent with the mechanism of action for RIPK2
Filing
1 more on record.
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 2 immunology/inflammation companies
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.