VANCOUVER - Zymeworks Inc . (NASDAQ:ZYME), a biotechnology firm specializing in biotherapeutics, has announced the U.S. Food and Drug Administration's (FDA) accelerated approval of Ziihera (zanidatamab-hrii) for HER2-positive biliary tract cancer (BTC). This approval marks the first FDA endorsement of a dual HER2-targeted bispecific antibody for this cancer type, providing a new option for patients who have exhausted other treatments.
Ziihera's approval was based on a 52% objective response rate and a median duration of response of 14.9 months from the HERIZON-BTC-01 clinical trial. While this accelerated approval is contingent upon further verification in a confirmatory trial, it represents a significant milestone for Zymeworks, validating their proprietary Azymetric™ technology used in the drug's development.
Zymeworks has also secured a $25 million milestone payment from Jazz Pharmaceuticals (NASDAQ:JAZZ) following the FDA approval, with the potential for up to $500 million more in regulatory milestones, as well as additional commercial milestones and tiered royalties on net sales.
The approval of Ziihera offers a chemotherapy-free treatment alternative for patients with previously-treated, unresectable or metastatic HER2-positive (IHC 3+) BTC, as detected by an FDA-approved test. This bispecific antibody works by binding to two extracellular sites on the HER2 receptor, leading to internalization and reduction of the receptor on tumor cells, potentially inhibiting tumor growth and inducing cell death.
Zanidatamab is currently under review in other regions, including China and Europe, and is being investigated in various tumor types beyond BTC, with ongoing Phase 3 trials in gastroesophageal adenocarcinomas and metastatic breast cancer.
The company's collaboration with Jazz Pharmaceuticals and BeiGene (NASDAQ:BGNE), Ltd. aims to advance zanidatamab's development and commercialization globally. Zymeworks continues to focus on a diverse pipeline of novel therapeutics for difficult-to-treat cancers, with several candidates in different development stages.
This news is based on a press release statement and does not reflect the views of any financial analysts or medical experts.
In other recent news, Zymeworks Inc. has seen significant advancements in its clinical programs, including bispecific T cell engagers and antibody-drug conjugates (ADCs). Leerink Partners has upgraded Zymeworks' stock rating from Market Perform to Outperform, raising the price target to $25. This upgrade comes with anticipation of the PDUFA date for zanidatimab, an outlicensed product, and the progression of the company's pipeline into the clinical stage. Leerink's positive reassessment of Zymeworks' stock potential is due to the company's recent progress and a valuation model that projects worldwide peak revenues exceeding $4 billion. Zymeworks has reported a Q3 2024 net loss of $99.2 million, which, despite being a loss, is an improvement from the previous year. The company also announced plans to file Investigational New Drug (IND) applications for two promising ADCs, ZW220 and ZW251, in 2025 and completed a $30 million stock repurchase program. Lastly, Zymeworks is open to future business development opportunities, including collaborations and licensing deals.
InvestingPro Insights
The FDA's accelerated approval of Ziihera marks a significant milestone for Zymeworks Inc. (NASDAQ:ZYME), potentially transforming its financial outlook. According to InvestingPro data, Zymeworks has a market capitalization of $1 billion USD, reflecting investor confidence in the company's potential following this regulatory success.
Despite the recent approval, it's important to note that Zymeworks is not currently profitable, with a negative gross profit of $62.46 million USD in the last twelve months as of Q3 2023. This aligns with an InvestingPro Tip indicating that analysts do not anticipate the company to be profitable this year. However, the approval of Ziihera and potential milestone payments could significantly impact future financial performance.
Interestingly, Zymeworks has shown strong market performance, with a 77.01% price total return over the past year. This positive trend is further supported by another InvestingPro Tip highlighting that two analysts have revised their earnings upwards for the upcoming period, suggesting growing optimism about the company's prospects.
For investors seeking a more comprehensive analysis, InvestingPro offers 11 additional tips for Zymeworks, providing deeper insights into the company's financial health and market position.
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