JZP3507 (ONC206)

Nov. 2, 2026: Jazz Pharmaceuticals plc (NASDAQ: JAZZ) announced upcoming neuro-oncology presentations at the 2026 Society for Neuro-Oncology Annual Meeting (Nov. 12-15, Philadelphia).

Modeyso (dordaviprone, formerly ONC201): Jazz said the confirmatory Phase 3 ACTION trial in newly diagnosed H3 K27M-mutant diffuse glioma is ongoing, with patients randomized to placebo, once-weekly dordaviprone, or twice-weekly dordaviprone after frontline radiotherapy; the primary endpoint is overall survival. An interim analysis is planned for 1H 2027. Jazz also noted Modeyso already has FDA accelerated approval for adult and pediatric patients aged 1+ with H3 K27M-mutant diffuse midline glioma with progressive disease after prior therapy, and that full approval is contingent on verification of clinical benefit in ACTION. SNO presentations include an ACTION trial update poster and preclinical dordaviprone work in diffuse midline glioma, including immunomodulatory effects and combination with NK cell therapy.

JZP3507 (formerly ONC206): Jazz said a Phase 2 trial has been initiated in adults with recurrent grade 2 or 3 meningioma. At SNO, Jazz will present the Phase 2 study design and preclinical data in H3 G34-mutant glioma showing nanomolar potency and a ClpP-dependent anti-cancer mechanism.