Biopharma Transcript

Odyssey Therapeutics, Inc. ODTX

Nasdaq · Phase 2 · GI/hepatology · small molecule · EDGAR · Updated Nov 5, 2026

Odyssey Therapeutics, Inc. (Nasdaq: ODTX) is a GI/hepatology drug developer. Its lead program, OD-001, is in Phase 2 for ulcerative colitis. Its next catalyst on record is Cash runway: Cash resources expected to fund operations (H2 2028).

Upcoming catalysts

No catalyst is dated to the next 30 days or to an FDA action date.

Next further out: Cash runway — Cash resources expected to fund operations (H2 2028). 1 catalyst on record beyond the next 30 days; subscribers see each with its filing sentence.

Pipeline

ProgramIndicationModalityStage
OD-001ulcerative colitissmall moleculePhase 2
OD-002interferonopathies / systemic lupus erythematosussmall moleculePre-clinical
OD-003autoimmune diseasesprotein/peptidePre-clinical
OD-004inflammatory diseasesbiologic-otherPre-clinical
IRAK4 scaffolding inhibitorautoimmune diseasessmall moleculePre-clinical
IRF5 inhibitor (Terray collaboration)interferonopathiessmall moleculePre-clinical

Recent results and decisions

  1. Nov 4, 2026
    positive Additional Phase 2a induction analyses for OD-001 presented at UEG Week further strengthen clinical proof of concept in ulcerative colitis with concordant biomarker and transcriptomic findings.Clinical efficacy results are supported by concordant findings across clinical outcomes and inflammatory biomarkers, mucosal transcriptomics, and histologic improvement, further reinforcing the clinical proof of concept. Filing
  2. Oct 20, 2026
    met 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
  3. Oct 20, 2026
    n/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

4 more on record.

For subscribers

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