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MarketBeat
Mon, March 2, 2026 astatine 9:37 AM CST 8 min read
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Zymeworks Offers Hope for More than Just Long-Term Investors
Zymeworks (NASDAQ:ZYME) executives utilized the company’s fourth-quarter 2025 results telephone to item updated objective information for its partnered HER2 antibody zanidatamab, outline a caller royalty-backed financing with Royalty Pharma, and supply 2025 fiscal results and pipeline updates crossed aggregate early-stage programs.
Chair, CEO, and interim CFO Ken Galbraith opened by pointing to results from the Phase 3 HERIZON-GEA-01 proceedings presented astatine ASCO GI by partners Jazz Pharmaceuticals and BeiGene. In first-line metastatic oregon locally precocious HER2-positive gastroesophageal adenocarcinoma (GEA), zanidatamab successful operation with chemotherapy, with oregon without a checkpoint inhibitor, demonstrated a median progression-free endurance exceeding 1 twelvemonth and median wide endurance exceeding 2 years, which Galbraith described arsenic a clinically meaningful result successful a mounting with historically constricted semipermanent survival.
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Galbraith said an further planned interim investigation for median wide endurance for the zanidatamab positive chemotherapy regimen that “just missed” statistical value astatine the archetypal interim investigation is expected by mid-2026. He added that benefits were observed consistently crossed subgroups, and that PD-L1 look was assessed arsenic an exploratory endpoint alternatively than a stratification factor.
On the regulatory front, Galbraith said Jazz expects to implicit submission of a supplemental biologics licence exertion (sBLA) to the FDA successful the archetypal 4th of 2026 nether the Real-Time Oncology Review program. Zanidatamab has Breakthrough Therapy designation for HER2-positive GEA, helium noted, and the HERIZON-GEA-01 information person been submitted for inclusion successful NCCN guidelines. Galbraith said Zymeworks shares Jazz’s anticipation for U.S. support and motorboat for GEA successful the 2nd fractional of the year, taxable to FDA reappraisal and approval. He besides noted BeiGene is moving toward a supplemental BLA for tislelizumab successful the U.S. successful the archetypal fractional of 2026.
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The institution besides reported regulatory approvals during the 4th for zanidatamab monotherapy successful Canada and the United Kingdom for second-line biliary tract cancer. Galbraith framed the broader zanidatamab programme arsenic a instauration for aboriginal milestone and royalty streams. He said Zymeworks expects the programme could construe into regulatory milestone payments for planetary approvals successful GEA of up to $440 million, positive an further $89 cardinal collectively from Jazz and BeiGene upon support successful a 3rd denotation beyond biliary tract crab and GEA. The institution is besides eligible for up to $977.5 cardinal successful commercialized milestone payments tied to income thresholds, with Galbraith stating that astir $1.5 cardinal successful milestone payments stay imaginable nether the Jazz and BeiGene collaboration agreements.
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