Zymeworks Hits 52-Week High on 'Unprecedented' Cancer Drug Results
Phase 3 data shows its zanidatamab therapy extends survival past two years in stomach cancer, prompting partner Jazz Pharma to ready FDA submission.
Zymeworks (NASDAQ: ZYME) shares surged to a new 52-week high this week after the company announced what it called “unprecedented results” from a pivotal study of its lead cancer drug, zanidatamab. The stock touched $28.49 as investors reacted to data showing the treatment extended life beyond two years in a hard-to-treat stomach cancer.
The Vancouver-based biopharmaceutical company’s stock saw significant trading volume after a press release detailed positive topline results from its Phase 3 HERIZON-GEA-01 trial. The study evaluated zanidatamab in patients with HER2-positive locally advanced or metastatic gastroesophageal adenocarcinoma (GEA). In the trial, a combination involving zanidatamab achieved a median Overall Survival (OS) of more than two years for first-line patients.
This result is a significant milestone in a disease where historical survival rates have been much lower. Following the initial surge, the stock settled at $24.19 in recent trading, a move analysts often attribute to profit-taking after a sharp run-up. The company's market capitalization now stands at approximately $2 billion.
The Strategic Importance of the Trial
The strong data solidifies the outlook for zanidatamab, a bispecific antibody that targets two different parts of the HER2 protein. The drug is part of a major strategic partnership for Zymeworks. In 2022, Jazz Pharmaceuticals (NASDAQ: JAZZ) acquired development and commercialization rights to zanidatamab in a deal valued at up to $1.76 billion.
Following the successful data readout, Jazz announced its intention to submit a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) in the first half of 2026. The data is also slated for presentation at a major medical meeting in the first quarter of the year, which will give clinicians and the scientific community their first detailed look at the findings.
If approved, zanidatamab could become a new standard of care for first-line HER2-positive GEA, a significant commercial opportunity. According to its company profile, Zymeworks is focused on developing biotherapeutics for various types of cancer, with zanidatamab being its most advanced asset.
Market and Analyst Reaction
The positive outcome has been a key driver for Zymeworks' valuation, which has more than doubled from its 52-week low of $9.03. Wall Street analysts remain broadly optimistic on the company's prospects, with a consensus 12-month price target of $35.54, suggesting considerable upside from its current trading level. Of a dozen analysts covering the stock, eleven rate it as a 'Buy' or 'Strong Buy'.
The enthusiasm extends to Zymeworks’ partner, Jazz Pharmaceuticals. In the wake of the announcement, analysts at several banks, including RBC Capital and Piper Sandler, reiterated 'Outperform' or 'Overweight' ratings on Jazz, with some raising their price targets. The success of zanidatamab is seen as a major value driver for both companies.
What Comes Next?
The immediate focus for Zymeworks and Jazz will be the formal presentation of the HERIZON-GEA-01 data and the subsequent regulatory submissions with the FDA and other global health authorities. A successful approval would trigger milestone payments to Zymeworks and secure a stream of future royalties on sales.
For investors, the success of the trial de-risks a major part of the Zymeworks story and validates its underlying technology platform. While the stock has already seen a significant rally, the upcoming regulatory catalysts and the potential for zanidatamab to be investigated in other HER2-expressing cancers provide a clear forward-looking path for the company.