This section highlights FDA-related milestones and regulatory updates for drugs developed by Zymeworks (ZYME).
Over the past two years, Zymeworks has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
ZW1528, ZW171, ZW191, ZW209, ZW220, and ZW251. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
ZW1528 - FDA Regulatory Timeline and Events
ZW1528 is a drug developed by Zymeworks for the following indication: a Bispecific Antibody Targeting IL-4Rα and IL-33, Potently Inhibits Key Mediators of Airway Inflammation.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ZW1528
- Announced Date:
- May 19, 2025
- Estimated Event Date Range:
- July 1, 2025 - December 31, 2025
- Target Action Date:
- 2025-H2
- Indication:
- a Bispecific Antibody Targeting IL-4Rα and IL-33, Potently Inhibits Key Mediators of Airway Inflammation
Announcement
Zymeworks announced that Regulatory filing to support Phase 1 studies expected in 2H-2026
AI Summary
Zymeworks announced that it plans to file regulatory documentation to support Phase 1 studies of its first development candidate for autoimmune and inflammatory diseases in the second half of 2026. The candidate is a bispecific antibody designed to block key signaling pathways by targeting IL-4Rα and IL-33. This dual mechanism significantly inhibits the activity of cytokines IL-4, IL-13, and IL-33, which are critical drivers of respiratory inflammation seen in diseases like COPD. The preclinical data shows that this novel approach can effectively suppress inflammatory responses, and the molecule has demonstrated promising manufacturability and stability, even at high concentrations suitable for subcutaneous administration. This filing marks an important step in advancing Zymeworks’ innovative strategy to improve treatments for respiratory disorders, potentially providing better therapeutic control for a broader group of patients.Read Announcement
- Drug:
- ZW1528
- Announced Date:
- May 19, 2025
- Indication:
- a Bispecific Antibody Targeting IL-4Rα and IL-33, Potently Inhibits Key Mediators of Airway Inflammation
Announcement
Zymeworks announced the presentation of new preclinical data for ZW1528, a novel IL-4Rα x IL-33 bispecific molecule designed to address respiratory inflammation, at the American Thoracic Society (ATS) International Conference being held May 18-21, 2025 in San Francisco, CA.
AI Summary
Zymeworks announced that it will present new preclinical data for its candidate, ZW1528, at the American Thoracic Society International Conference in San Francisco from May 18-21, 2025. ZW1528 is a novel IL-4Rα x IL-33 bispecific molecule designed to tackle respiratory inflammation by simultaneously blocking IL-4, IL-13, and IL-33 signaling pathways. This dual-targeting approach aims to improve treatment for conditions like COPD by inhibiting multiple pathways that drive inflammation. The preclinical studies showed high-affinity binding to both targets, effective suppression of inflammatory responses in primary human immune cells, and promising results in animal lung inflammation models. Additionally, ZW1528 demonstrated properties that support high dosing concentrations and potential for subcutaneous administration. The company is hopeful that these findings will translate into better respiratory disease management and set the stage for further clinical development.
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ZW171 - FDA Regulatory Timeline and Events
ZW171 is a drug developed by Zymeworks for the following indication: For mesothelin (MSLN)-expressing cancers.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ZW171
- Announced Date:
- March 25, 2025
- Indication:
- For mesothelin (MSLN)-expressing cancers.
Announcement
Zymeworks Inc announced the acceptance of six abstracts for poster presentation at the upcoming American Association for Cancer Research (AACR) Annual Meeting being held April 24-30, 2025 in Chicago, IL.
AI Summary
Zymeworks Inc. announced that six abstracts have been accepted for poster presentations at the upcoming American Association for Cancer Research (AACR) Annual Meeting, which will take place from April 24-30, 2025, in Chicago, IL. This news highlights the company’s continued commitment to advancing innovative cancer treatments. Among the six abstracts, one focuses on ZW209, a DLL3-targeting trispecific T cell engager that incorporates CD28 co-stimulation. Preclinical data for ZW209 demonstrate its potent anti-tumor activity in small cell lung cancer models along with a favorable pharmacokinetics and safety profile in non-human primates. The acceptance of these abstracts at AACR underscores Zymeworks’ ongoing efforts in developing novel biotherapeutics for difficult-to-treat cancers, providing promising insights into potential improvements for patient outcomes.
Read Announcement- Drug:
- ZW171
- Announced Date:
- June 17, 2024
- Indication:
- For mesothelin (MSLN)-expressing cancers.
Announcement
Zymeworks Inc announced that the United States Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application for ZW171, a novel 2+1 T-cell targeting bispecific antibody for mesothelin (MSLN)-expressing cancers.
AI Summary
Zymeworks Inc. recently announced a major milestone as the FDA cleared the investigational new drug (IND) application for its novel candidate, ZW171. This breakthrough treatment is a unique 2+1 T-cell targeting bispecific antibody designed specifically for cancers that express mesothelin (MSLN). The innovative design of ZW171 aims to improve on current therapies by offering better tumor selectivity and safety, lowering the risks of off-tumor effects and cytokine release syndrome while maintaining strong anti-tumor activity.
ZW171’s development is based on promising preclinical results, and it holds potential for treating various MSLN-expressing cancers such as ovarian, non-small cell lung cancer, and mesothelioma. With its targeted approach, Zymeworks hopes that ZW171 will provide a more effective and tolerable option in cancer therapy as the company plans to begin clinical trials later this year.
Read Announcement- Drug:
- ZW171
- Announced Date:
- June 17, 2024
- Estimated Event Date Range:
- July 1, 2024 - December 31, 2024
- Target Action Date:
- 2024-H2
- Indication:
- For mesothelin (MSLN)-expressing cancers.
Announcement
Zymeworks Inc The Company expects to file applications seeking regulatory permission to commence clinical studies for ZW171 in other non-US jurisdictions in the second half of 2024.
AI Summary
Zymeworks Inc., a clinical-stage biotechnology company, is advancing its innovative cancer treatment research with its new candidate, ZW171. This novel bispecific antibody is designed to target mesothelin-expressing tumor cells by engaging T cells, offering hope for patients with cancers like ovarian cancer, non-small cell lung cancer, and mesothelioma. With promising preclinical results, Zymeworks is focused on expanding the reach of ZW171 beyond the United States. In the second half of 2024, the company expects to file applications seeking regulatory permission in non-US jurisdictions to begin clinical studies. This effort is part of Zymeworks’ broader mission to develop safer and more effective therapies for difficult-to-treat diseases, and it highlights the company’s commitment to improving patient outcomes through advanced, targeted treatment strategies.
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ZW191 - FDA Regulatory Timeline and Events
ZW191 is a drug developed by Zymeworks for the following indication: A Novel Folate Receptor-⍺ Targeted Topoisomerase I Inhibitor Antibody-Drug Conjugate.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ZW191
- Announced Date:
- July 22, 2024
- Indication:
- A Novel Folate Receptor-⍺ Targeted Topoisomerase I Inhibitor Antibody-Drug Conjugate
Announcement
Zymeworks Inc announced that the United States Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application for ZW191, the Company's novel folate receptor-⍺ (FR⍺) targeted topoisomerase I inhibitor (TOPO1i) antibody-drug conjugate (ADC).
AI Summary
Zymeworks Inc. recently announced that the US Food and Drug Administration has cleared the investigational new drug application for its novel drug candidate, ZW191. This investigational therapy is an antibody-drug conjugate (ADC) designed specifically to target the folate receptor-α, which is known to be present in several challenging cancers such as ovarian and non-small cell lung cancer. ZW191 incorporates a new antibody, an innovative drug-linker, and a potent topoisomerase I inhibitor payload, ensuring a strong balance of antibody-linker stability and payload efficacy. With a drug-antibody ratio of eight, the therapy is designed to be effective even at lower levels of folate receptor-α expression, potentially enhancing its anti-tumor activity. This FDA clearance represents a significant milestone, paving the way for the initiation of clinical development of ZW191 in 2024.
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ZW209 - FDA Regulatory Timeline and Events
ZW209 is a drug developed by Zymeworks for the following indication: For small cell lung cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ZW209
- Announced Date:
- April 25, 2025
- Indication:
- For small cell lung cancer
Announcement
Zymeworks announced the presentation of six posters with new preclinical data from its preclinical, development-stage, and clinical programs at the American Association for Cancer Research (AACR) Annual Meeting being held April 25-30, 2025 in Chicago, IL.
AI Summary
Zymeworks Inc. announced that they will present six posters featuring new preclinical data at the American Association for Cancer Research (AACR) Annual Meeting in Chicago, IL from April 25‑30, 2025. The posters showcase progress across multiple program stages, highlighting work in both antibody‑drug conjugates and T cell engager platforms. Notably, the presentations include promising data on the novel T cell engager ZW209. This trispecific therapeutic, which integrates CD28 co‑stimulation, has demonstrated durable anti‑tumor activity in preclinical small cell lung cancer models. ZW209 is one of the company’s key oncology candidates, with an investigational new drug (IND) submission expected in the first half of 2026. These efforts underline Zymeworks’ commitment to advancing innovative, differentiated therapies that may significantly improve cancer treatment outcomes.
Read Announcement- Drug:
- ZW209
- Announced Date:
- April 25, 2025
- Estimated Event Date Range:
- January 1, 2026 - June 30, 2026
- Target Action Date:
- 2026-H1
- Indication:
- For small cell lung cancer
Announcement
Zymeworks announced that Novel T cell engager ZW209 demonstrates durable activity in small cell lung cancer; IND submission expected in 1H-2026
AI Summary
Zymeworks announced promising preclinical data for its novel T cell engager, ZW209, designed for small cell lung cancer. Preclinical studies showed that ZW209 has durable antitumor activity in models of small cell lung cancer by integrating CD28 co-stimulation into its trispecific design. This unique approach enhances T cell responses, leading to robust and sustained tumor cell killing even after repeated challenges at low effector-to-target ratios.
Additionally, non-human primate studies demonstrated favorable pharmacokinetic properties and safety following repeat dosing. Based on these encouraging results, Zymeworks plans to move ZW209 forward by submitting an Investigational New Drug (IND) application in the first half of 2026. This development could provide a promising new treatment option for patients with aggressive DLL3-expressing small cell lung cancer.
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ZW220 - FDA Regulatory Timeline and Events
ZW220 is a drug developed by Zymeworks for the following indication: For non-small cell lung, ovarian, and uterine cancers.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ZW220
- Announced Date:
- September 18, 2024
- Indication:
- For non-small cell lung, ovarian, and uterine cancers
Announcement
Zymeworks Inc announced presentation highlighting result from recent preclinical research for Zymeworks' antibody-drug conjugate candidates ZW220
AI Summary
Zymeworks Inc. announced an upcoming presentation that will highlight encouraging preclinical results for its antibody-drug conjugate candidate, ZW220. The company’s research focuses on the activity of ZW220 in models of non-small cell lung, ovarian, and uterine cancers. This candidate uses a novel, proprietary topoisomerase I inhibitor payload, which has shown promising activity and a favorable toxicology profile in non-human primates. The findings will be shared at the prestigious European Organisation for Research and Treatment of Cancer-National Cancer Institute-American Association for Cancer Research Conference in Barcelona later this month, emphasizing the potential of ZW220 to improve cancer treatment standards. The presentation is part of a broader effort to advance next-generation ADC programs and aligns with Zymeworks’ planned investigational new drug filings in 2025.
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ZW251 - FDA Regulatory Timeline and Events
ZW251 is a drug developed by Zymeworks for the following indication: In hepatocellular carcinoma models.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ZW251
- Announced Date:
- September 18, 2024
- Indication:
- In hepatocellular carcinoma models
Announcement
Zymeworks Inc announced presentation highlighting result from recent preclinical research for Zymeworks' antibody-drug conjugate candidates ZW251
AI Summary
Zymeworks Inc. recently announced that it will present new preclinical research results on its antibody-drug conjugate candidate, ZW251, at the upcoming European Organisation for Research and Treatment of Cancer-National Cancer Institute-American Association for Cancer Research (EORTC-NCI-AACR) Conference in Barcelona. The presentation will focus on ZW251, which is designed to target glypican-3 and includes a topoisomerase I inhibitor payload. Early preclinical studies indicate that ZW251 shows strong activity in hepatocellular carcinoma models, suggesting a promising future for the therapy in treating liver cancer. The research highlights the company’s efforts in advancing next-generation antibody-drug conjugate programs aimed at improving treatment outcomes for cancers with unmet medical needs. This work is part of Zymeworks’ ongoing development of innovative biotherapeutics that may potentially lead to investigational new drug filings in 2025.
Read Announcement
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