Jazz Pharmaceuticals plc (JAZZ) Wins FDA Accelerated Approval for Modeyso™ Brain Cancer Therapy

We recently compiled a list of the 10 Overlooked Healthcare Stocks to Invest in. Jazz Pharmaceuticals plc is one of them.

Jazz Pharmaceuticals plc (NASDAQ:JAZZ) is a specialty pharmaceutical company focused on neuroscience, oncology, and rare diseases, with a global presence and products including Xywav and Epidiolex.

In August 2025, Jazz Pharmaceuticals plc (NASDAQ:JAZZ) received FDA accelerated approval for Modeyso™ (dordaviprone), the first therapy for adult and pediatric patients with recurrent diffuse midline glioma carrying the H3 K27M mutation. This breakthrough addresses a critical unmet need in an aggressive brain cancer and represents a strategic expansion beyond the company’s legacy sleep disorder portfolio. The corporation plans an investor webcast on August 27, 2025, to present clinical data and commercialization strategy for Modeyso™.

The business also presented late-breaking clinical data at SLEEP 2025, including Phase 4 results for Xywav in narcolepsy, survival data for Ziihera in HER2-positive biliary tract cancer, and combination therapy data for Zepzelca with Tecentriq in small cell lung cancer, showing meaningful survival benefits.

Jazz Pharmaceuticals plc (JAZZ) Wins FDA Accelerated Approval for Modeyso™ Brain Cancer Therapy

Jazz Pharmaceuticals plc (NASDAQ:JAZZ) will participate in the 2025 Wells Fargo Healthcare Conference in September to discuss pipeline progress and strategic plans.

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