Latest news with #Zymeworks'
Yahoo
3 days ago
- Business
- Yahoo
Zymeworks' zanidatamab gains approval in China for biliary tract cancer
China's National Medical Products Administration (NMPA) has conditionally approved Zymeworks' zanidatamab for treating individuals with prior treated, unresectable or metastatic human epidermal growth factor receptor 2-positive (HER2+) biliary tract cancer (BTC). This marks a milestone as zanidatamab is the first dual HER2-targeted bispecific antibody authorised for this indication in the country, specifically for those with high HER2 expression (IHC3+). The approval by the NMPA is a result of Zymeworks' collaboration with BeOne Medicines (previously known as BeiGene), which secured this approval under the terms of their Asia Pacific licence and partnership agreement. The continuation of this approval is contingent upon the clinical benefit verification in the patients, which is expected to be demonstrated through the current confirmatory trials. As part of the agreement with BeOne, Zymeworks has already obtained $61m (C$83.48m) in upfront and milestone payments, along with joint development funding for clinical trials of the therapy. With the NMPA's approval, Zymeworks is set to obtain a milestone payment of an additional $20m and may earn up to $144m in further development and commercial milestones. Moreover, the company is entitled to tiered royalties on net sales, which could reach up to 19.5% in BeOne's territories. Zymeworks CEO and chair Kenneth Galbraith said: 'Zanidatamab's conditional approval in China is a meaningful advancement for patients living with HER2-positive BTC, a population with historically high unmet need and poor prognoses. 'This milestone affirms the strength of zanidatamab's clinical potential and reflects our continued focus on translating innovation into real impact for patients around the globe. We are deeply grateful to our partners at BeOne Medicines, and to the patients, families and clinical teams whose contributions have made this milestone a reality.' The therapy secured approval from the US Food and Drug Administration (FDA) last November for the same indication. This April, Jazz Pharmaceuticals, Zymeworks' partner, secured a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use for the approval of the therapy to treat advanced HER2-positive BTC. "Zymeworks' zanidatamab gains approval in China for biliary tract cancer" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Sign in to access your portfolio
Yahoo
17-04-2025
- Business
- Yahoo
Zymeworks to Report First Quarter 2025 Financial Results and Host Conference Call on May 8, 2025
VANCOUVER, British Columbia, April 17, 2025 (GLOBE NEWSWIRE) -- Zymeworks Inc. (Nasdaq: ZYME), a clinical-stage biotechnology company developing a diverse pipeline of novel, multifunctional biotherapeutics to improve the standard of care for difficult-to-treat diseases, including cancer, inflammation, and autoimmune disease, today announced that management will report its first quarter 2025 financial results after market close on May 8, 2025. Following the announcement, management will host a conference call and webcast to discuss financial results and provide a corporate update on May 8, 2025 at 4:30 pm Eastern Time. The event will be webcast live with dial-in details and webcast replays available on Zymeworks' website at About Zymeworks Inc. Zymeworks is a global clinical-stage biotechnology company committed to the discovery, development, and commercialization of novel, multifunctional biotherapeutics. Zymeworks' mission is to make a meaningful difference in the lives of people impacted by difficult-to-treat conditions such as cancer, inflammation, and autoimmune disease. The Company's complementary therapeutic platforms and fully integrated drug development engine provide the flexibility and compatibility to precisely engineer and develop highly differentiated antibody-based therapeutic candidates. Zymeworks engineered and developed zanidatamab, a HER2-targeted bispecific antibody using the Company's proprietary Azymetric™ technology. Zymeworks has entered into separate agreements with BeiGene, Ltd. (BeiGene) and Jazz Pharmaceuticals Ireland Limited (Jazz Pharmaceuticals), granting each exclusive rights to develop and commercialize zanidatamab in different territories. The U.S. FDA granted accelerated approval of Ziihera® (zanidatamab-hrii) 50mg/mL for injection for intravenous use for the treatment of adults with previously-treated, unresectable or metastatic HER2-positive (IHC 3+) second-line biliary tract cancer (BTC). Ziihera® is the first and only dual HER2-targeted bispecific antibody approved for HER2-positive BTC in the U.S. Zanidatamab is currently under regulatory review in the EU and China for second-line BTC and is being evaluated in multiple global clinical trials as a potential best-in-class treatment for patients with multiple HER2-expressing cancers. Zymeworks is rapidly advancing a robust pipeline of wholly-owned product candidates, leveraging its expertise in both antibody-drug conjugates and multispecific antibody therapeutics targeting novel pathways in areas of significant unmet medical need. Phase 1 studies for ZW171 and ZW191 are now actively recruiting with an investigational new drug application for ZW251 planned for mid-2025. In addition to Zymeworks' pipeline, its therapeutic platforms have been further leveraged through strategic partnerships with global biopharmaceutical companies. For information about Zymeworks, visit and follow @ZymeworksInc on X. Contacts: Investor Inquiries:Shrinal InamdarSenior Director, Investor Relations(604) 678-1388ir@ Media Inquiries:Diana PapoveSenior Director, Corporate Communications(604) 678-1388media@ in to access your portfolio
Yahoo
10-03-2025
- Business
- Yahoo
Analysts Just Shipped A Captivating Upgrade To Their Zymeworks Inc. (NASDAQ:ZYME) Estimates
Zymeworks Inc. (NASDAQ:ZYME) shareholders will have a reason to smile today, with the analysts making substantial upgrades to this year's forecasts. The consensus statutory numbers for both revenue and earnings per share (EPS) increased, with their view clearly much more bullish on the company's business prospects. Following the upgrade, the current consensus from Zymeworks' seven analysts is for revenues of US$95m in 2025 which - if met - would reflect a huge 25% increase on its sales over the past 12 months. The loss per share is anticipated to greatly reduce in the near future, narrowing 20% to US$1.40. However, before this estimates update, the consensus had been expecting revenues of US$84m and US$1.61 per share in losses. We can see there's definitely been a change in sentiment in this update, with the analysts administering a sizeable upgrade to this year's revenue estimates, while at the same time reducing their loss estimates. View our latest analysis for Zymeworks Despite these upgrades, the analysts have not made any major changes to their price target of US$19.61, implying that their latest estimates don't have a long term impact on what they think the stock is worth. Of course, another way to look at these forecasts is to place them into context against the industry itself. It's pretty clear that there is an expectation that Zymeworks' revenue growth will slow down substantially, with revenues to the end of 2025 expected to display 25% growth on an annualised basis. This is compared to a historical growth rate of 33% over the past five years. Juxtapose this against the other companies in the industry with analyst coverage, which are forecast to grow their revenues (in aggregate) 20% annually. So it's pretty clear that, while Zymeworks' revenue growth is expected to slow, it's expected to grow roughly in line with the industry. The highlight for us was that the consensus reduced its estimated losses this year, perhaps suggesting Zymeworks is moving incrementally towards profitability. They also upgraded their revenue forecasts, although the latest estimates suggest that Zymeworks will grow in line with the overall market. The lack of change in the price target is puzzling, but with a serious upgrade to this year's earnings expectations, it might be time to take another look at Zymeworks. Still, the long-term prospects of the business are much more relevant than next year's earnings. We have estimates - from multiple Zymeworks analysts - going out to 2027, and you can see them free on our platform here. Of course, seeing company management invest large sums of money in a stock can be just as useful as knowing whether analysts are upgrading their estimates. So you may also wish to search this free list of stocks with high insider ownership. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.
