Zymeworks Inc. develops and manages licensed healthcare assets while advancing a pipeline of novel, multifunctional biotherapeutics for oncology. Company news centers on Ziihera (zanidatamab-hrii) and zanidatamab-related regulatory and clinical updates, including HER2-targeted development, as well as ZW191, a folate receptor alpha-targeting antibody-drug conjugate with Fast Track designation for advanced or metastatic platinum-resistant ovarian cancer.
Recurring updates also cover antibody-drug conjugate platform work, including RAS inhibitor ADC programs and targets such as CLDN18.2, Ly6E and PTK7, along with financial results, cash resources, share repurchase activity, investor conference participation and executive leadership appointments.
Zymeworks (Nasdaq: ZYME) presented Phase 1 dose-optimization results for ZW191 in patients with platinum-resistant ovarian cancer at ESMO Congress 2026. The analysis covered 80 patients randomized to 6.4 or 9.6 mg/kg every three weeks, with seven months’ median follow-up. Among response-evaluable patients with high-grade serous disease, confirmed tumor response rates were 64.5% and 55.3%, respectively; activity was observed across folate receptor alpha expression levels.
Median response duration was not yet reached at either dose. Six-month progression-free survival was 61% in both groups; median progression-free survival was 7.9 and 9.8 months, respectively. Grade 3 or higher treatment-related adverse events occurred in 22% and 44%, respectively. No deaths due to treatment-emergent adverse events were reported. Progression-free survival data remain immature, especially at 6.4 mg/kg. Results will inform dose selection for further development.
Zymeworks (Nasdaq: ZYME) entered an exclusive global license and collaboration agreement with Roche for ZW209, with a $55 million upfront payment. ZW209 is a trispecific T cell engager targeting DLL3. Zymeworks is also eligible for $40 million upon Phase 1b trial initiation, up to $718 million in additional development, commercial and sales-based milestones, and tiered high-single-digit to mid-teen royalties on future net sales of approved medicines resulting from the collaboration.
Roche will fund the Phase 1a monotherapy trial, which Zymeworks will conduct in collaboration with Roche. Roche will handle subsequent global development and commercialization. U.S. FDA clearance to begin clinical testing has been received; Zymeworks plans additional regulatory applications to support study sites outside the U.S. Closing remains subject to the HSR antitrust waiting period and, where applicable, other required regulatory approvals.
Zymeworks (Nasdaq: ZYME) has appointed Suzanne Monahan as Senior Vice President, Commercial and General Manager, Theravance Biopharma, effective immediately.
She will report directly to Chair and Chief Executive Officer Kenneth Galbraith and lead commercial strategy and execution for YUPELRI (revefenacin) following Zymeworks’ recent acquisition of Theravance Biopharma. YUPELRI is approved in the U.S. for maintenance treatment of chronic obstructive pulmonary disease. Monahan brings more than 20 years of commercial leadership experience and most recently served as Senior Vice President at Pacira BioSciences.
Zymeworks (ZYME) will report its third quarter 2026 financial results after market close on November 9, 2026. The company does not plan a results call or webcast. Management will attend investor conferences in New York on November 10–12 and in London on November 17. Live webcasts of certain fireside chats and subsequent replays will be available on its investor website.
Zymeworks (ZYME) completed its acquisition of Theravance Biopharma for $17.00 per share, adding YUPELRI profit-sharing rights.
Through Theravance’s collaboration with Viatris, Zymeworks is entitled to 35% of U.S. net profits from YUPELRI and royalties on sales outside the United States. The purchase used a $350 million non-recourse note from OMERS and approximately $217.5 million of Zymeworks cash after using cash acquired from Theravance. Until the note is repaid, 75% of YUPELRI profit-share cash flows will service it.
Zymeworks expects 2026 revenue of $278 million to $292 million and adjusted EBITDA of $114 million to $128 million. Adjusted EBITDA excludes certain expenses. Acquisition and restructuring costs are estimated at approximately $25 million to $30 million. A potential $100 million TRELEGY ELLIPTA payment depends on a sales milestone being met by year-end 2026.
Zymeworks (ZYME) completed its previously announced acquisition of Theravance Biopharma on September 23, 2026, making Theravance part of the company. Zymeworks says the acquisition supports its goal of combining drug development with commercial and royalty-based cash flows.
Zymeworks will discuss the final transaction details on a call with investors and the general public on September 28 at 8:30 a.m. Eastern Time.
Zymeworks (Nasdaq: ZYME)/b) reported that partner Jazz Pharmaceuticals received U.S. FDA approval for two -based first-line regimens for adults with unresectable locally advanced or metastatic HER2-positive gastroesophageal adenocarcinoma (GEA): Ziihera plus Tevimbra (tislelizumab) plus fluoropyrimidine- and platinum-containing chemotherapy (HER2+ IHC 3+ and IHC 2+/ISH+), and Ziihera plus chemotherapy (HER2+ IHC 3+).
This is the second U.S. FDA approval for zanidatamab in less than two years. Approval triggers a $250 million milestone from Jazz, bringing total Jazz-related upfront and milestones to $650 million, with up to $1.3 billion in additional potential milestones and 10%–20% tiered royalties on Jazz net sales.
Under its BeOne Medicines collaboration, Zymeworks has received $81 million to date and remains eligible for up to $144 million in additional milestones plus up to 19.5% tiered royalties. The company highlights these partnered economics as providing non-dilutive capital to fund its wholly owned trispecific T‑cell engager and antibody-drug conjugate pipeline.
Zymeworks (Nasdaq: ZYME), a biotechnology company focused on licensed healthcare assets and novel biotherapeutics, announced management participation in several September 2026 investor conferences. These include events hosted by Wells Fargo, Citi, Morgan Stanley, and H.C. Wainwright, featuring one-on-one investor meetings and fireside chats in Boston and New York.
Zymeworks (Nasdaq: ZYME) reported 2Q 2026 revenue of $4.6 million versus $48.7 million a year earlier and a net loss of $45.0 million versus net income of $2.3 million, with R&D expenses down 20% to $27.4 million and G&A up to $19.3 million. Cash, cash equivalents and marketable securities totaled $322.5 million at June 30, 2026.
The company highlighted an August 25, 2026 U.S. PDUFA target action date for zanidatamab in 1L HER2+ GEA, tied to a potential $250 million U.S. approval milestone and up to $440 million in total potential global regulatory milestones. Zymeworks expects its proposed 2H 2026 acquisition of Theravance Biopharma to be earnings‑accretive, adding YUPELRI cash flows (~$60 million annualized at current run‑rates), additional royalties, milestones and $2.5 billion in Irish tax attributes, financed mainly by a $350 million non‑recourse note and Theravance’s expected $360 million net cash.
Zymeworks (Nasdaq: ZYME) announced it will report its second quarter 2026 financial results after market close on August 6, 2026. The company also noted that, in light of its previously announced proposed acquisition of Theravance Biopharma, it has chosen not to host a second quarter earnings conference call following the release. Zymeworks stated that it expects to provide a further update after the anticipated closing of the proposed Theravance Biopharma acquisition, at which time it plans to offer greater visibility into the combined business and its strategic priorities.