Ziihera (zanidatamab-hrii) is a Jazz Pharmaceuticals plc, Zymeworks Inc. program in first-line HER2-positive gastroesophageal adenocarcinoma (GEA). The FDA approved it on Aug 25, 2026. 2 FDA decisions on record below. Every date links its source.
JAZZ catalyst hub · ZYME catalyst hub
All upcoming FDA decision dates on the 2026 PDUFA calendar
FDA approval tracked on pdufa.bio: first-line HER2-positive gastroesophageal adenocarcinoma (GEA) (approved Aug 25, 2026). Earlier approvals may not be listed here; the FDA label is the full record. Sponsor: Jazz Pharmaceuticals plc, Zymeworks Inc. (JAZZ, ZYME). Market-cap tier at the time we tracked it: Large. We track 2 catalyst events for this program: 0 upcoming and 2 in the record. A PDUFA date is the FDA's target date to complete review of a marketing application; a readout is the sponsor's expected date for clinical trial results. What a PDUFA date is · why we do not compare trial results across drugs.
| Fund | Shares | Value at quarter end | Filing |
|---|---|---|---|
| Perceptive Advisors | 170,000 | $41.0 million | filed August 14, 2026 |
13F reports list long positions in common stock at quarter end, are due 45 days later, and show no short positions or later trades. Notes, warrants and other instruments are not counted as shares.
| Fund | Shares | Value at quarter end | Filing |
|---|---|---|---|
| EcoR1 Capital | 22,970,388 | $600.4 million | filed August 14, 2026 |
| Perceptive Advisors | 4,182,953 | $109.3 million | filed August 14, 2026 |
| BVF Inc. | 3,649,142 | $95.4 million | filed August 14, 2026 |
| Redmile Group | 491,654 | $12.9 million | filed August 14, 2026 |
13F reports list long positions in common stock at quarter end, are due 45 days later, and show no short positions or later trades. Notes, warrants and other instruments are not counted as shares.
No upcoming catalyst is on our calendar for Ziihera (zanidatamab-hrii); 2 FDA decisions are on record below.
On Aug 25, 2026 the FDA approved the application. The decision page carries the source document and the measured share-price reaction.
In our records Ziihera (zanidatamab-hrii) is FDA-approved for first-line HER2-positive gastroesophageal adenocarcinoma (GEA) (approved Aug 25, 2026). Other approved uses may not be tracked here; the FDA label is the full record.
Jazz Pharmaceuticals plc, Zymeworks Inc. (JAZZ, ZYME).
Yes. The FDA approved an application for Ziihera (zanidatamab-hrii) on Aug 25, 2026; the decision page linked above carries the source.
FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.