Jazz secures FDA approval for Ziihera in advanced HER2+ GEA

Jazz Pharmaceuticals (JAZZ) announced a $1.0 billion private offering of exchangeable senior notes due 2032, with an option for $150 million more. The notes are guaranteed by Jazz and will be used for general corporate purposes. The company also plans to repurchase up to $225 million of its ordinary shares concurrently, using existing cash.

The FDA approved Jazz Pharmaceuticals' Ziihera (zanidatamab-hrii) in combination with chemotherapy, with or without BeOne Medicines USA's Tevimbra (tislelizumab-jsgr), for HER2-positive gastroesophageal adenocarcinoma. Approval was based on the HERIZON-GEA-01 trial showing improved progression-free and overall survival. Companion diagnostics from Roche Diagnostics were also approved.

Jazz Pharmaceuticals (JAZZ) stock rose 2.3% after the FDA approved two Ziihera-containing regimens for HER2-positive gastroesophageal adenocarcinoma. The approval, anticipated since August 2026, pushed shares to a new high of $266.38. Analysts had raised price targets following strong Q2 2026 earnings, with revenue at $1.21 billion. The broader market saw modest gains, with the S&P 500 and Dow Jones up 0.2%, and the Nasdaq up 0.4%.

Jazz Pharmaceuticals (JAZZ) shares rose 2.3% after FDA approved Ziihera for HER2-positive gastroesophageal adenocarcinoma. The approval covers all HER2+ patients and is based on trial results showing reduced disease progression and extended survival. Ziihera is the first bispecific HER2-targeted antibody combined with a PD-1 inhibitor and chemotherapy approved for this indication.

Jazz Pharmaceuticals' stock rose after the FDA approved its cancer drug Ziihera, which competes with Roche's Herceptin and Perjeta. The approval was for treating a form of stomach cancer in combination with chemotherapy.

Jazz Pharmaceuticals (JAZZ) received FDA approval for two Ziihera (zanidatamab-hrii)-containing regimens to treat HER2-positive gastroesophageal adenocarcinoma. Approval was based on Phase 3 trial results showing improved survival rates. JAZZ stock is up 3.50% at $263.48.