Common Stock, $0.00001 par value per share
- Symbol
- ZYME
- Exchange
- NASDAQ
- Classification
- COMMON
- Status
- Current
Current Report · Items 7.01, 8.01, 9.01 · 8-K
Zymeworks Inc.
ZYMENASDAQEQUITYCurrent
Regulation FD Disclosure · Other Events
ITEM 7.01 REGULATION FD DISCLOSURES On August 25, 2026, Zymeworks Inc. (“Company”) issued a press release announcing that its partner, Jazz Pharmaceuticals, has received U.S. Food and Drug Administration (“FDA”) approval for two Ziihera® (zanidatamab-hrii)-containing regimens for the first-line treatment of adults with unresectable locally advanced or metastatic HER2-positive (HER2+) gastroesophag…
Company context
Zymeworks is a global biotechnology company building a diversified portfolio of healthcare assets designed to generate durable cash flows while advancing innovative medicines for difficult-to-treat diseases. Zymeworks’ asset and royalty aggregation strategy combines a growing portfolio of commercial and near-commercial assets, including YUPELRI® (revefenacin), with a differentiated internal research and development engine. Zymeworks’ portfolio also includes Ziihera® (zanidatamab-hrii), a HER2-targeted bispecific antibody discovered and developed by Zymeworks and commercialized through global partnerships with Jazz Pharmaceuticals and BeOne Medicines, and pasritamig, a clinical-stage multispecific antibody developed by Johnson & Johnson using Zymeworks’ proprietary antibody engineering technologies.
Current securities
Registered securities in this filing
Zymeworks Inc. · 8-K · Filed 2026-08-25
Disclosure sections
Item 7.01Item 7.01 - Regulation FD Disclosure
ITEM 7.01 REGULATION FD DISCLOSURES
On August 25, 2026, Zymeworks Inc. (“Company”) issued a press release announcing that its partner, Jazz Pharmaceuticals, has received U.S. Food and Drug Administration (“FDA”) approval for two Ziihera® (zanidatamab-hrii)-containing regimens for the first-line treatment of adults with unresectable locally advanced or metastatic HER2-positive (HER2+) gastroesophageal adenocarcinoma (“GEA”): Ziihera plus Tevimbra® (tislelizumab-jsgr) and fluoropyrimidine- and platinum-containing chemotherapy (HER2+ IHC 3+ and IHC 2+/ISH+), and Ziihera plus fluoropyrimidine- and platinum-containing chemotherapy (HER2+ IHC 3+). A copy of this press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information provided under this Item 7.01 (including Exhibit 99.1 attached hereto) is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Item 8.01Item 8.01 - Other Events
ITEM 8.01 REGULATION FD DISCLOSURES
Zymeworks BC Inc. (“Zymeworks”), a subsidiary of the Company, is a party to an Amended and Restated License and Collaboration Agreement (as amended, the “License and Collaboration Agreement”) with Jazz Pharmaceuticals Ireland Limited, a subsidiary of Jazz Pharmaceuticals plc, collectively referred to as “Jazz,” granting Jazz exclusive rights to develop and commercialize Zymeworks’ proprietary bispecific HER2 antibody product candidate known as zanidatamab throughout the world, but excluding certain territories already covered by Zymeworks’ agreement with BeOne Medicines Ltd.
As announced on August 25, 2026, Zymeworks’ partner, Jazz, has received FDA approval for two Ziihera® (zanidatamab-hrii)-containing regimens for the first-line treatment of adults with unresectable locally advanced or metastatic HER2-positive (HER2+) GEA: Ziihera plus Tevimbra® (tislelizumab-jsgr) and fluoropyrimidine- and platinum-containing chemotherapy (HER2+ IHC 3+ and IHC 2+/ISH+), and Ziihera plus fluoropyrimidine- and platinum-containing chemotherapy (HER2+ IHC 3+).
Pursuant to the terms of the License and Collaboration Agreement, Zymeworks has earned a milestone payment of $250 million based on the FDA approval in GEA. Zymeworks remains eligible to receive up to $1.3 billion in additional regulatory and commercial milestones, as well as tiered royalties of 10% to 20% on Jazz’s net sales of zanidatamab in Jazz’s licensed territories.
For additional information regarding the License and Collaboration Agreement, please refer to the Company’s Current Reports on Form 8-K, filed with the U.S. Securities and Exchange Commission on October 19, 2022 and on May 16, 2023.