Zymeworks Stock Price, News & Analysis

Zymeworks Inc. (NYSE: ZYME) has presented new clinical data for its bispecific antibody, zanidatamab, targeting HER2 in advanced HER2-expressing biliary tract cancer (BTC) and gastroesophageal adenocarcinoma (GEA) at the ASCO Gastrointestinal Cancers Symposium. The updated results show promising response rates, with an overall response rate (ORR) of 39% in GEA patients treated with zanidatamab alone, and 60% with paclitaxel in combination. Additionally, zanidatamab received Breakthrough Therapy designation from the FDA for HER2-positive BTC, signaling potential for accelerated approval.

Zymeworks Inc. (NYSE: ZYME) reported key achievements in 2020, highlighting advancements in its lead clinical program, zanidatamab. The pivotal trial for HER2 gene-amplified biliary tract cancer was initiated, targeting accelerated approval and a potential Biologics License Application by 2022. Zymeworks secured Breakthrough Therapy and Orphan Drug designations to expedite commercialization. With partnerships advancing and cash runways extended through a public offering raising $320.8 million, Zymeworks aims for data-rich developments in 2021, focusing on HER2-expressing cancers.

Zymeworks Inc. (NYSE: ZYME) will present at the 39th Annual J.P. Morgan Healthcare Conference on January 11, 2021, at 3:40 p.m. ET. Additionally, Zymeworks will host two webcasts: one on January 15, 2021, at 5:00 p.m. ET, discussing clinical results for zanidatamab in biliary tract and gastroesophageal cancers, and another on January 27, 2021, at 4:30 p.m. ET, updating on ZW49’s clinical progress. The webcasts can be accessed via Zymeworks' website, with replays available shortly after.

Zymeworks Inc. (NYSE: ZYME) announced its participation in the ASCO Gastrointestinal Cancers Symposium, scheduled for January 15-17, 2021, presenting updated clinical data for zanidatamab. This HER2-targeted bispecific antibody is being tested in gastroesophageal adenocarcinoma and biliary tract cancer. A pivotal trial for HER2-amplified biliary tract cancer is currently recruiting globally. The FDA granted Breakthrough Therapy designation and Fast Track designations for zanidatamab, indicating significant support for its development in treating solid tumors.

Zymeworks Inc. (NYSE: ZYME) announced a significant milestone with its partner BeiGene, Ltd. having dosed the first patient in South Korea for a pivotal clinical trial of zanidatamab in patients with advanced HER2-amplified biliary tract cancer. As a result, Zymeworks will receive a US$10 million payment under their collaboration agreement. The trial aims to enhance treatment options for patients with this aggressive cancer type that often has poor outcomes.

Zymeworks Inc. (NYSE: ZYME) announced that the FDA granted Breakthrough Therapy designation to its drug zanidatamab for patients with previously-treated HER2 gene-amplified biliary tract cancer (BTC). This designation allows for accelerated approval, priority review, and rolling review, highlighting zanidatamab's potential to significantly improve existing treatments. A Phase 2b registration study is ongoing to support this designation, with plans for a Biologics License Application submission in 2022. BTC is a rare cancer with limited treatment options, with zanidatamab being a promising targeted therapy.

Zymeworks Inc. (NYSE:ZYME) has received Orphan Drug designation from the European Commission for zanidatamab, an investigational bispecific antibody targeting HER2 in gastric cancer. This designation signifies significant therapeutic benefits and offers advantages such as 10 years of market exclusivity and reduced regulatory fees. Zymeworks previously gained similar designations from the US FDA for gastric, biliary tract, and ovarian cancers. Officials highlight the high incidence of gastric cancer in Europe as a reason for the drug's importance in their clinical portfolio.

Zymeworks Inc. (NYSE: ZYME) and ALX Oncology Holdings Inc. (NASDAQ: ALXO) have announced a clinical collaboration to evaluate the combination of Zymeworks' zanidatamab and ALX148 for treating advanced HER2-expressing breast cancer and other solid tumors. The study will be a two-part Phase 1b trial assessing the safety and efficacy of this combination. Zanidatamab is already in advanced clinical trials for various cancers, while ALX148 has shown promise in previous studies. This collaboration aims to enhance the therapeutic potential for patients.

Zymeworks Inc. (NYSE:ZYME), a clinical-stage biopharmaceutical company, will participate in four virtual investor conferences in November 2020. Key presentations include:

• Stifel’s Virtual Healthcare Conference on November 17, at 4:40 p.m. ET.
• Jefferies’ Virtual London Healthcare Conference on November 18, at 11:25 a.m. ET.
• Wolfe’s Virtual Healthcare Conference on November 19, at 2:20 p.m. ET.
• SVB Leerink's Oncology Day on November 19 without a public presentation.

Live webcasts will be available on Zymeworks' website.