Jazz Receives FDA Approval For Ziihera Regimens In First-Line HER2+ Gastroesophageal Cancer

Jazz Pharmaceuticals (JAZZ) awaits an FDA decision on August 25, 2026, for its drug Ziihera (zanidatamab-hrii), a HER2-targeted bispecific antibody co-developed with BeOne (ONC). The FDA accepted Jazz's sBLA, supported by Phase 3 study data for treating HER2-positive gastric cancer.

Jazz Pharmaceuticals agreed to acquire private Actio Biosciences in a deal potentially worth just over $1.3B. Actio would get $820M upfront and up to $500M tied to regulatory and sales milestones. Actio’s lead KCNT1-related epilepsy drug is in testing. Closing is expected in Q4, with a funded spinout. Jazz reported $1.2B total quarterly revenue, up 16% YoY.

Jazz Pharmaceuticals said it will acquire Actio Biosciences for $820 million upfront plus up to $500 million in contingent payments tied to sales or approval milestones. The deal targets Actio’s oral therapy ABS-1230 for KCNT1-related epilepsy, where no FDA-approved treatments exist. Jazz expects closing by Q4, with Actio’s other pipeline spun off into a new private company.

Jazz Pharmaceuticals agreed to acquire Actio Biosciences for $820m upfront, plus up to $500m in contingent payments. The deal, approved by both boards, is expected to close in Q4 2026. Jazz will fund it with cash and existing facilities. Actio’s lead asset ABS-1230 targets KCNT1+ epilepsy and is in a Phase Ib/IIa KYRON trial.

Jazz Pharmaceuticals (JAZZ) agreed to buy privately held Actio Biosciences for $820M upfront plus up to $500M contingent consideration. Actio’s lead asset ABS-1230 targets KCNT1+ epilepsy, with no FDA-approved therapies. ABS-1230 has Fast Track, Orphan, and Rare Pediatric Disease designations and is in the Phase 1b/2a KYRON trial. JAZZ stock closed at $256.56.

Jazz Pharmaceuticals said it will seek FDA removal of the second-line indication for lurbinectedin (Zepzelca) in metastatic small-cell lung cancer. Jazz plans a labeling supplement submission in Q3 2026. The indication was accelerated in 2020. The phase 3 LAGOON trial failed its overall survival endpoint, with median OS 8.7 vs 10.7 months (HR 1.19) for monotherapy. First-line maintenance remains unchanged.