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Zymeworks (ZYME) FDA Events

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FDA Events for Zymeworks (ZYME)

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.

Zymeworks' Drugs in FDA Review

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.

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.

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.

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.

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.

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.

Zymeworks FDA Events - Frequently Asked Questions

However, the company does has had drugs under review or in active clinical development.

In the past two years, Zymeworks (ZYME) has reported FDA regulatory activity for the following drugs: ZW171, ZW1528, ZW209, ZW251, ZW220 and ZW191.

The most recent FDA-related event for Zymeworks occurred on May 19, 2025, involving ZW1528. The update was categorized as "Regulatory filing," with the company reporting: "Zymeworks announced that Regulatory filing to support Phase 1 studies expected in 2H-2026"

Current therapies from Zymeworks in review with the FDA target conditions such as:

  • For mesothelin (MSLN)-expressing cancers. - ZW171
  • a Bispecific Antibody Targeting IL-4Rα and IL-33, Potently Inhibits Key Mediators of Airway Inflammation - ZW1528
  • For small cell lung cancer - ZW209
  • In hepatocellular carcinoma models - ZW251
  • For non-small cell lung, ovarian, and uterine cancers - ZW220
  • A Novel Folate Receptor-⍺ Targeted Topoisomerase I Inhibitor Antibody-Drug Conjugate - ZW191

More FDA Event Resources from MarketBeat

  • NDA: New Drug Application
  • ANDA: Abbreviated New Drug Application
  • sNDA: Supplemental New Drug Application
  • BLA: Biologics License Application
  • sBLA: Supplemental Biologics License Application
  • FDA Approved: Approved by the FDA
  • EMA: European Medicines Agency
  • CE Mark: European Union Certification
  • NMPA: China National Medical Products Administration
  • MHLW: Japanese Ministry of Health
  • FDA Meeting: Consultation with FDA
  • Pre-IND: Pre-Investigational New Drug Meeting
  • Breakthrough Therapy: Special FDA designation for promising therapies
  • Fast Track: Accelerated FDA approval pathway
  • Orphan Drug: Designation for rare disease treatments
  • RPD: Rare Pediatric Disease Designation
  • RMAT: Regenerative Medicine Advanced Therapy
  • DSMB Review: Data Safety Monitoring Board Review
  • IDMC Review: Independent Data Monitoring Committee
  • MAA: MHRA Marketing Authorization Application
  • RTF: Refusal to File (Rejected Application)
  • 510(k): FDA Clearance for Medical Devices
  • Rolling Submission: Staggered regulatory review process

This page (NYSE:ZYME) was last updated on 7/10/2025 by MarketBeat.com Staff
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