Zymeworks (NASDAQ:ZYME), a clinical-stage biotechnology company developing novel, bispecific antibody therapeutics, provided a strategic update outlining key priorities for 2026, anchored by recent clinical and regulatory progress for its lead candidate Ziihera (zanidatamab-hrii).
The company reported positive topline results from the Phase 3 HERIZON-GEA-01 trial evaluating Ziihera in combination with chemotherapy as a first-line treatment for patients with HER2-positive advanced or metastatic gastroesophageal adenocarcinoma (GEA).
Zymeworks plans to submit a supplemental biologics license application (sBLA) to the U.S. Food and Drug Administration in the first half of 2026, seeking to expand Ziihera's approved indications beyond its current accelerated approval in previously treated biliary tract cancer.
Zymeworks highlighted significant potential regulatory milestone payments tied to Ziihera and other pipeline programs, totaling up to $440 million, including $250 million from the United States, $100 million from the European Union, $75 million from Japan, and $15 million from China.
As of December 31, 2025, the company maintained a strong liquidity position with cash and marketable securities of approximately $270.6 million.