- Jazz Pharmaceuticals (JAZZ, Financial) completes $935 million acquisition of Chimerix.
- Dordaviprone, a treatment for H3 K27M-mutant diffuse glioma, is under FDA Priority Review.
- PDUFA decision date for dordaviprone set for August 18, 2025.
Jazz Pharmaceuticals (NASDAQ: JAZZ) has successfully completed its acquisition of Chimerix for approximately $935 million in cash. This transaction marks a significant addition to Jazz's oncology portfolio, as it now includes dordaviprone, a novel first-in-class small molecule treatment designed for H3 K27M-mutant diffuse glioma, a rare and aggressive form of brain cancer.
Dordaviprone is currently undergoing FDA Priority Review, with a Prescription Drug User Fee Act (PDUFA) action date scheduled for August 18, 2025. If approved, dordaviprone could become the first and only FDA-approved therapy specifically targeting H3 K27M-mutant diffuse glioma, offering a promising near-term commercial opportunity for Jazz.
Furthermore, dordaviprone is part of the ongoing Phase 3 ACTION trial, aiming to evaluate its effectiveness in newly diagnosed, non-recurrent H3 K27M-mutant diffuse glioma patients following radiation treatment. This could potentially expand its use into a first-line treatment setting. The acquisition also opens the possibility for Jazz to receive a Rare Pediatric Disease Priority Review Voucher (PRV) if the drug gains FDA approval.
This strategic move enhances Jazz Pharmaceuticals' position in the oncology field and underscores its commitment to addressing significant unmet medical needs, particularly in the treatment of rare diseases.
