Welcome to our dedicated page for Zymeworks news (Ticker: ZYME), a resource for investors and traders seeking the latest updates and insights on Zymeworks stock.
Zymeworks Inc. develops and manages licensed healthcare assets while advancing a pipeline of novel, multifunctional biotherapeutics for oncology. Company news centers on Ziihera (zanidatamab-hrii) and zanidatamab-related regulatory and clinical updates, including HER2-targeted development, as well as ZW191, a folate receptor alpha-targeting antibody-drug conjugate with Fast Track designation for advanced or metastatic platinum-resistant ovarian cancer.
Recurring updates also cover antibody-drug conjugate platform work, including RAS inhibitor ADC programs and targets such as CLDN18.2, Ly6E and PTK7, along with financial results, cash resources, share repurchase activity, investor conference participation and executive leadership appointments.
Zymeworks Inc. (NYSE: ZYME) reported a 32% revenue increase in 2020, reaching $39.0 million, up from $29.5 million in 2019. The growth was driven by milestone payments from partnerships. Research and development expenses rose significantly to $168.5 million, reflecting expanded clinical trials for zanidatamab and ZW49. The company received a Breakthrough Therapy designation for zanidatamab, paving the way for pivotal trials in 2021. Additionally, Zymeworks strengthened its balance sheet with a $320.8 million public financing.
Zymeworks Inc. (NYSE: ZYME) announced its participation in five upcoming virtual investor conferences. Key events include the Barclays Global Healthcare Conference on March 11, 2021, where Zymeworks will present at 1:15 p.m. ET. Other conferences include the Guggenheim Healthcare Talks and SVB Leerink’s 10th Annual Global Healthcare Conference, both without public presentations. Interested parties can access a live webcast of the Barclays presentation on Zymeworks’ website. Zymeworks focuses on developing advanced biotherapeutics, including its lead candidate, zanidatamab.
Zymeworks Inc. (NYSE: ZYME) has announced the promotion of James Priour to Chief Commercial Officer and the addition of Manny Duenas as Vice President of Global Value & Access. John Babcook transitions to a newly created role of Distinguished Fellow. The company aims to leverage their leadership changes to enhance the commercialization of their lead candidate, zanidatamab, which has received Breakthrough Therapy designation from the FDA. Zymeworks continues to advance its pipeline, including ZW49, and focus on gaining access to their therapies for patients globally.
Zymeworks Inc. (NYSE: ZYME) has initiated patient enrollment in the expansion cohort of its ongoing Phase 1 clinical trial for ZW49, a HER2-targeted antibody-drug conjugate. The trial's dose escalation portion confirmed no dose-limiting toxicities in 35 patients, with mild to moderate adverse events reported. ZW49 displayed antitumor activity with partial responses and stable disease noted across various HER2-positive cancers. Expansion cohorts for HER2-positive breast cancer and gastroesophageal adenocarcinoma are now open, with further data expected at an upcoming medical conference.
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.