Zymeworks flags August 25 PDUFA date for zanidatamab, updates pipeline and Theravance timeline
Zymeworks said the FDA's target action date on zanidatamab in gastric cancer falls on August 25, 2026, while the Theravance Biopharma acquisition is still expected to close in the second half of the year.
Zymeworks Inc. said the FDA has set an August 25, 2026 U.S. PDUFA target action date for zanidatamab for the treatment of patients with first-line HER2-positive locally advanced or metastatic gastroesophageal adenocarcinoma.1 The company said the approval decision has potential to unlock a $250 million U.S. approval milestone and up to $190 million in potential additional global regulatory milestones.1 A U.S. approval would be the first of up to a total of $440 million potential global regulatory milestones for zanidatamab in 1L HER2+ GEA.1
On the trial front, Zymeworks said top-line results from the second interim overall survival analysis for the "HERIZON-GEA-01" trial doublet regimen are expected in the third quarter of 2026.1 Separately, in a different late-stage study, the EmpowHER-303 trial is expected to complete patient enrollment in mid-2027 with top-line data expected by the end of 2027 or early 2028.1
For its partnered prostate cancer program, Zymeworks said J&J increased the planned enrollment for its Phase 3 trial of pasritamig in combination with best supportive care in patients with late-line metastatic castration-resistant prostate cancer, from approximately 663 to 1,203 participants.1 The company added that the anticipated primary completion date is now estimated as December 2027, compared with the previously estimated May 2028 date.1
On the pending Theravance Biopharma deal, Zymeworks said the transaction remains expected to close in 2H 2026, adding durable commercial cash flows and expanding Zymeworks' diversified revenue base.1 Financing will come primarily from a $350 million non-recourse note secured by U.S. YUPELRI profit share from OMERS Life Sciences, and Theravance Biopharma's expected net cash balance of $360 million at closing, with Zymeworks contributing the remainder of the purchase price in cash.1
As of June 30, 2026, the company reported $322.5 million of cash resources consisting of cash, cash equivalents and marketable securities, comprised of $179.4 million in cash and cash equivalents and $143.1 million in marketable securities.1 Zymeworks said that given its shift toward a revenue-generating model, it no longer intends to provide cash runway guidance.1
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