UNITED STATES
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FORM
CURRENT REPORT
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Item 8.01 Other Events.
On June 10, 2024, Zymeworks Inc. (the “Company”) announced that the Center for Drug Evaluations (“CDE”) of the National Medical Products Administration (“NMPA”) in China has accepted the biologics license application (“BLA”) for zanidatamab for second-line treatment of HER2-positive biliary tract cancer (“BTC”). Under the terms of the Company’s Asia Pacific license and collaboration agreement with BeiGene, Ltd. for the development and commercialization of zanidatamab, the Company is entitled to receive an $8 million milestone payment upon acceptance of the BLA by the NMPA. The NMPA acceptance follows the announcement in May 2024 by the Company’s partner Jazz Pharmaceuticals plc regarding the U.S. Food and Drug Administration’s (“FDA”) acceptance and grant of priority review of the BLA for zanidatamab for the treatment of previously treated, unresectable, locally advanced, or metastatic HER2-positive BTC. Under the Prescription Drug User Fee Act, the FDA has set a target action date of November 29, 2024.
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
ZYMEWORKS INC. | ||||||
| (Registrant) | ||||||
| Date: June 10, 2024 | By: | /s/ Kenneth Galbraith | ||||
| Name: | Kenneth Galbraith | |||||
| Title: | Chair, President, Chief Executive Officer and interim Chief Financial Officer | |||||
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Document and Entity Information |
Jun. 10, 2024 |
|---|---|
| Cover [Abstract] | |
| Document Type | 8-K |
| Document Period End Date | Jun. 10, 2024 |
| Entity Registrant Name | Zymeworks Inc. |
| Entity Incorporation State Country Code | DE |
| Entity File Number | 001-41535 |
| Entity Tax Identification Number | 88-3099146 |
| Entity Address Address Line 1 | 108 Patriot Drive, Suite A |
| Entity Address City Or Town | Middletown |
| Entity Address State Or Province | DE |
| Entity Address Postal Zip Code | 19709 |
| City Area Code | 302 |
| Local Phone Number | 274-8744 |
| Written Communications | false |
| Soliciting Material | false |
| Pre Commencement Tender Offer | false |
| Pre Commencement Issuer Tender Offer | false |
| Security 12b Title | Common Stock, par value $0.00001 per share |
| Trading Symbol | ZYME |
| Security Exchange Name | NASDAQ |
| Entity Emerging Growth Company | false |
| Entity Central Index Key | 0001937653 |
| Amendment Flag | false |