Jazz Pharmaceuticals (JAZZ) announced that the U.S. FDA has granted accelerated approval for Modeyso (dordaviprone) for the treatment of adult and pediatric patients 1 year of age and older with diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the Phase 3 ACTION confirmatory trial.
Elevate Your Investing Strategy:
- Take advantage of TipRanks Premium at 50% off! Unlock powerful investing tools, advanced data, and expert analyst insights to help you invest with confidence.
Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>>
Read More on JAZZ:
- Jazz Pharmaceuticals wins accelerated FDA approval of dordaviprone
- Positive Growth Outlook for Jazz Pharmaceuticals Amid Strategic Developments and Promising Drug Pipeline
- Jazz Pharmaceuticals price target lowered to $200 from $230 at Truist
- Jazz Pharmaceuticals: Strong Buy Rating Backed by Robust Growth and Promising Pipeline
- Jazz Pharmaceuticals Reports Q2 2025 Results and CEO Transition