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Zymeworks Inc. (Nasdaq: ZYME) is a global biotechnology company committed to the discovery, development, and commercialization of novel, multifunctional biotherapeutics. The company's mission is to make a meaningful difference for people impacted by difficult-to-treat cancers and other serious diseases.
Zymeworks specializes in developing best-in-class bi-specific antibodies and antibody-drug conjugates (ADCs) to treat oncology, autoimmunity, and inflammatory diseases. Their proprietary platforms, including Azymetric™, Albucore™, and ZymeLink™, enable the creation of highly potent bi-specific antibodies and multivalent protein therapeutics targeting a range of indications.
The company's leading therapeutic candidate, zanidatamab, is a novel HER2-targeted bispecific antibody currently in multiple Phase 1, Phase 2, and pivotal clinical trials globally. Zanidatamab is being developed as a targeted treatment for patients with HER2-expressing cancers. Recent milestones include the acceptance of a Biologics License Application (BLA) by the FDA and China's National Medical Products Administration (NMPA) for second-line treatment of HER2-positive biliary tract cancers (BTC).
Zymeworks is also advancing a deep preclinical pipeline, including candidates like zanidatamab zovodotin (ZW49) and new investigational drugs ZW171 and ZW191, with plans for multiple IND filings in 2024 and 2025. The company is financially robust, with a cash runway extending into the second half of 2027, bolstered by strategic partnerships with BeiGene and Jazz Pharmaceuticals, among others.
The company's complementary therapeutic platforms and fully integrated drug development engine enable precise engineering of differentiated product candidates, offering potential best-in-class treatments for various challenging diseases. For more information, visit www.zymeworks.com.
Zymeworks Inc. (NYSE:ZYME) has announced a conference call and webcast on November 9 at 4:15 p.m. ET, detailing the launch of its Phase 3 HERIZON-GEA-01 study for zanidatamab in treating HER2-positive gastroesophageal adenocarcinoma (GEA). The study compares zanidatamab plus chemotherapy with the standard trastuzumab plus chemotherapy. Zanidatamab, a bispecific antibody, has received several FDA designations, including Breakthrough Therapy and Fast Track, indicating its potential in the treatment landscape for solid tumors expressing HER2.
Zymeworks Inc. (NYSE: ZYME) and ALX Oncology Holdings Inc. (NASDAQ: ALXO) have initiated a Phase 1b/2 clinical trial, dosing the first patient to assess the safety and efficacy of zanidatamab combined with evorpacept for advanced HER2-positive breast and solid tumors. This combination aims to improve immune clearance of cancer cells. Zanidatamab, a bispecific antibody, is designed to target HER2, while evorpacept blocks the CD47 pathway, potentially enhancing therapeutic effects. This collaboration follows promising results from prior studies involving evorpacept in gastric cancers.
Zymeworks Inc. (NYSE: ZYME) has announced promising clinical results for zanidatamab, a HER2-targeted therapy for first-line HER2-positive gastroesophageal adenocarcinoma (GEA). Data from a Phase 2 study presented at the ESMO Congress showed a confirmed objective response rate (cORR) of 75%, and 93% for the proposed Phase 3 regimen. The median duration of response was 16.4 months. A global Phase 3 trial is planned to start in Q4 2021, which aims to establish zanidatamab as a new standard of care in combination with chemotherapy.
Zymeworks Inc. (NYSE: ZYME) announced new clinical data for zanidatamab, a HER2-targeted bispecific antibody, showing promising results in treating first-line HER2-expressing gastroesophageal adenocarcinoma (GEA). In a trial involving 30 patients, the objective response rate was 68.2%, and the disease control rate reached 90.9%. The updated data will be presented at the ESMO Annual Congress on September 16. Zymeworks is positioning zanidatamab as a foundational HER2-targeted therapy, supported by FDA designations for accelerated approval.
Zymeworks Inc. (NYSE: ZYME) reported second-quarter 2021 financial results, with revenue of $1.8 million, down from $12.4 million in Q2 2020. The net loss increased to $67.5 million compared to $39.0 million last year, attributed to decreased revenue and increased expenses. The company is preparing for pivotal trials for zanidatamab in HER2-positive cancer and has initiated new clinical studies. Despite the challenges, Zymeworks maintains $359.8 million in cash, projecting operational funding into 2022.
Zymeworks Inc. (NYSE: ZYME) announced that Janssen Biotech has dosed the first patient with JNJ-78278343, a bispecific antibody developed using Zymeworks' Azymetric™ and EFECT™ platforms. This milestone is part of their 2017 licensing agreement, in which Zymeworks received an upfront payment of $50 million and could earn up to $282 million in development and $1.12 billion in commercial milestones. Zymeworks emphasizes the significance of its platform technologies to their business model, complementing their leading clinical assets.
Zymeworks Inc. (NYSE: ZYME) has initiated a Phase 1 trial, dosing the first patient with zanidatamab, combined with Tukysa® (tucatinib) and capecitabine, targeting HER2-positive breast cancer. This follows positive results from previous trials combining tucatinib with trastuzumab and chemotherapy. Zanidatamab employs a bispecific design to enhance anti-tumor activity and is viewed as a promising treatment for patients with advanced HER2-positive breast cancer. The FDA has granted Breakthrough Therapy designation for zanidatamab in specific cancer types, indicating potential accelerated approval for its use.
Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company, will present at the Ladenburg Thalmann Healthcare Conference on July 14, 2021, at 4:00 p.m. ET. The presentation can be viewed live or later via Zymeworks’ website. The company focuses on developing next-gen multifunctional biotherapeutics, with its lead candidate, zanidatamab (ZW25), granted Breakthrough Therapy designation by the FDA. It is currently enrolling patients in pivotal and Phase 2 trials for cancers like HER2-amplified biliary tract cancer. ZW49, another candidate, is in Phase 1 development.
Zymeworks Inc. (NYSE: ZYME) will present at the Jefferies Virtual Healthcare Conference from June 1-4, 2021. The Company’s presentation is scheduled for June 3, 2021, at 10:00 a.m. ET. Interested individuals can access the live webcast through Zymeworks’ website, with a recorded replay available later.
Zymeworks focuses on developing multifunctional biotherapeutics, including zanidatamab (ZW25), a bispecific antibody with FDA Breakthrough Therapy designation, currently undergoing pivotal clinical trials for biliary tract cancer and Phase 2 trials for other cancers.
Zymeworks Inc. (NYSE: ZYME) held its Annual General Meeting of Shareholders on May 5, 2021, where key proposals were voted on. Proposal 1 re-elected directors, with votes for each nominee exceeding 71%. Proposal 2 regarding executive compensation was also approved with 89.30% support. Proposal 3 confirmed the appointment of KPMG LLP as auditors, receiving 98.99% approval. The detailed voting results are accessible through SEDAR and EDGAR. The company continues to advance its innovative therapies, including zanidatamab, which has received Breakthrough Therapy designation from the FDA.