Jazz Pharmaceuticals stock rises after FDA approves Ziihera

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' 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.

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.