The U.S. Food and Drug Administration (FDA), on Tuesday, approved Jazz Pharmaceuticals plc’s (NASDAQ:JAZZ) two Ziihera-containing combination regimens as first-line treatments for adults with unresectable locally advanced or metastatic HER2-positive gastroesophageal adenocarcinoma.

“This approval is a major step forward for people with HER2+ advanced GEA. Ziihera is now the first and only bispecific HER2-targeted antibody combined with a PD-1 inhibitor and chemotherapy approved for all HER2+ advanced GEA patients, regardless of PD-L1 status, establishing a new standard of care in first-line treatment,” said Rob Iannone, M.D., M.S.C.E., executive vice president, global head of research and development, and chief medical officer of Jazz Pharmaceuticals. “The HERIZON-GEA-01 results include the longest median overall survival reported in a Phase 3 trial in this setting, at 26.4 months. We are grateful to the gastric cancer community, including patients, caregivers, investigators and advocacy organizations, whose partnership made this possible.”

Jazz Pharmaceuticals shares fell 0.8% to trade at $258.14 on Wednesday.

These analysts made changes to their price targets on Jazz Pharmaceuticals following the announcement.

  • Needham analyst Ami Fadia maintained the stock with a Buy and raised the price target from $292 to $310.
  • Truist Securities analyst Gregory Renza maintained the stock with a Buy and raised the price target from $264 to $281.

Considering buying JAZZ stock? Here’s what analysts think:

Photo via Shutterstock