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Zymeworks Appoints Dr. Adam Schayowitz as Acting Chief Development Officer
Globenewswire· 2025-10-09 10:00
VANCOUVER, British Columbia, Oct. 09, 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 the appointment of Adam Schayowitz, Ph.D., MBA as Acting Chief Development Officer. In this role, Dr. Schayowitz will report directly to Zymeworks’ Chair & Chief Executiv ...
BeOne Medicines (ONC) Gains Barclays Overweight Rating Ahead of Key 2025 Data Readouts
Yahoo Finance· 2025-10-02 05:35
BeOne Medicines Ltd. (NASDAQ:ONC) ranks among the best biotech stocks to buy. On September 18, Barclays began coverage of BeOne Medicines Ltd. (NASDAQ:ONC), rating it Overweight and setting a price target of $385 on the company’s shares. The firm cited two anticipated “value-inflecting pivotal data readouts” that might propel the oncology company’s growth. The first projected catalyst is data on BeOne’s BTK inhibitor in first-line mantle cell lymphoma, which is due in the latter half of 2025. Barclays al ...
Piper Sandler Reaffirms Jazz Pharmaceuticals (JAZZ) Price Target Ahead of Trial Data
Yahoo Finance· 2025-09-27 04:59
Jazz Pharmaceuticals plc (NASDAQ:JAZZ) ranks among the most undervalued NASDAQ stocks to buy now. Piper Sandler reaffirmed its Overweight rating and $147 price target for Jazz Pharmaceuticals plc (NASDAQ:JAZZ) on September 15 in expectation of data from the upcoming clinical trial. Jazz is gearing up to report progression-free survival data from its HERIZON-GEA-01 study in the fourth quarter of 2025. The trial assesses zanidatamab as the first-line therapy for advanced/metastatic gastroesophageal adenocarc ...
Jazz Pharmaceuticals plc (JAZZ) Advances Rare Cancer Portfolio with First CNS Glioma Therapy Approval
Yahoo Finance· 2025-09-23 23:11
Core Insights - Jazz Pharmaceuticals plc is recognized as one of the top pharmaceutical stocks to buy, focusing on innovative therapies for conditions with limited treatment options [2] - The company has received FDA accelerated approval for Modeyso, the first therapy for a rare CNS cancer, with a 22% overall response rate in clinical trials [3] - Jazz is expanding its portfolio in rare oncology, with ongoing developments for Zepzelca and zanidatamab, indicating a strong pipeline for future growth [4][5] Company Overview - Jazz Pharmaceuticals specializes in sleep medicine, epilepsy, and oncology, with key products including Xywav, Xyrem, Epidiolex, and Zepzelca [2] - Strategic acquisitions, such as GW Pharmaceuticals and Chimerix, have enhanced its drug pipeline with promising investigational therapies [2] Recent Developments - The FDA approval of Modeyso marks a significant milestone for Jazz, as it addresses an ultra-rare cancer with no prior treatment options [3] - The company is planning a supplemental New Drug Application for Zepzelca based on positive Phase III results, further solidifying its position in the oncology market [4] Future Outlook - Jazz Pharmaceuticals is expected to experience near-term growth driven by the commercial launch of Modeyso and ongoing pivotal trial results [5]
Jazz Pharmaceuticals plc (JAZZ) Wins FDA Nod for Modeyso in Rare Pediatric Brain Tumors
Yahoo Finance· 2025-09-16 13:30
Company Overview - Jazz Pharmaceuticals plc (NASDAQ:JAZZ) is a global biopharmaceutical leader focused on developing and commercializing therapies for complex conditions in oncology, neuroscience, and sleep medicine, with a portfolio that includes treatments for narcolepsy, epilepsy, and rare cancers [1]. Recent Developments - The company achieved a significant milestone with the FDA's accelerated approval of Modeyso (dordaviprone) on August 6, 2025, for treating H3 K27M-mutant diffuse midline glioma, a rare and aggressive brain cancer affecting approximately 2,000 patients annually in the U.S., primarily children and young adults [2]. - Modeyso is the first and only therapy approved for patients aged one year and older with progressive disease following prior treatment, demonstrating a 22% overall response rate in clinical trials among 50 patients, with a median response duration of 10.3 months; 73% of responders maintained their response for over six months [2]. - The drug is administered as a weekly oral capsule and will soon be commercially available, with continued approval dependent on the ongoing Phase 3 ACTION confirmatory trial [2]. Pipeline Expansion - In addition to Modeyso, Jazz Pharmaceuticals is diversifying its pipeline by licensing SAN2355, a preclinical epilepsy drug, thereby strengthening its neuroscience portfolio [3]. - In oncology, the company is advancing zanidatamab in Phase 3 for advanced gastroesophageal cancers and is pursuing regulatory approval for Zepzelca as a first-line treatment for extensive-stage small cell lung cancer [3].
Zymeworks(ZYME) - 2025 FY - Earnings Call Transcript
2025-09-04 21:30
Financial Data and Key Metrics Changes - The company has approximately $500 million left in regulatory milestones and about $860 million in commercial milestones, with royalties ranging from 10% to 20% based on net sales [10][11][12] Business Line Data and Key Metrics Changes - The zanidatamab program is a significant focus, with upcoming Phase 3 study readouts expected in Q4, which could drive value for the company [6][10] - ZW171 has been discontinued due to on-target, off-tumor toxicity, reflecting the company's disciplined approach to capital allocation [14][16][17] Market Data and Key Metrics Changes - The competitive landscape for zanidatamab includes potential opportunities in breast cancer, with Jazz Pharmaceuticals exploring this area [11][12] - ZW191 is positioned as a strong contender in the folate receptor alpha ADC space, with a focus on differentiating its product through superior internalization and potency [20][21][22] Company Strategy and Development Direction - The company emphasizes a disciplined approach to capital allocation and decision-making regarding its pipeline programs, focusing on those with the highest potential for patient benefit [14][16] - The strategy includes exploring partnerships for various programs, particularly ZW191, to enhance development and market reach [30][39] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming data readouts and the potential for zanidatamab to capture significant market value, estimating a valuation of over $2 billion [12][13][45] - The company is preparing for multiple catalysts over the next 12 to 18 months, including clinical studies for ZW251 and ZW209 [45] Other Important Information - The ZW209 program, utilizing a tri-TCE platform, is expected to enter clinical trials in the first half of 2026, showcasing the company's commitment to advancing its innovative pipeline [34][45] - The company is also exploring early-stage pipeline opportunities, including novel targets and ADCs, to leverage its protein engineering capabilities [33][34] Q&A Session Summary Question: What is the significance of the upcoming zanidatamab readout? - The readout is expected to provide clarity on the differentiation of zanidatamab in the competitive landscape, particularly in gastroesophageal adenocarcinoma [6][7] Question: What are the financial implications of the zanidatamab program? - The company has significant regulatory and commercial milestones associated with zanidatamab, which could lead to substantial revenue through royalties and milestone payments [10][11] Question: What led to the discontinuation of ZW171? - The decision was based on a lack of efficacy and on-target, off-tumor toxicity, demonstrating the company's commitment to prudent capital allocation [14][16][17] Question: How does Zymeworks differentiate its ADCs? - The company focuses on the holistic design of ADCs, ensuring that the antibody is optimized for internalization and payload delivery, which sets it apart from competitors [20][21][22] Question: What are the next steps for ZW191? - The company is considering partnerships for ZW191 and exploring various tumor types for clinical trials, including ovarian and endometrial cancers [30][39]
Jazz Pharmaceuticals Plc (JAZZ) Presents At Wells Fargo 20th Annual Healthcare Conference 2025 Transcript
Seeking Alpha· 2025-09-03 17:21
Overview - The company has experienced a positive year, with significant progress in both commercial and R&D aspects, particularly with the clinical trials of zanidatamab [1] Commercial Progress - The company has made notable advancements in driving business growth on the commercial side [1] R&D Developments - There has been progression in the clinical trials of zanidatamab, indicating ongoing commitment to research and development [1] Corporate Development - Recent announcements in corporate development suggest strategic moves that may enhance the company's market position [1]
Zymeworks Announces Decision to Discontinue Clinical Development of ZW171, a Mesothelin-directed T cell Engager
Globenewswire· 2025-09-02 10:00
Core Viewpoint - Zymeworks Inc. has decided to voluntarily discontinue the clinical development of ZW171, a T cell engager targeting specific cancers, after evaluating the results from the Phase 1 trial, which indicated that further development would not support a favorable benefit-risk profile [1][3][4]. Company Overview - Zymeworks Inc. is a clinical-stage biotechnology company focused on developing novel biotherapeutics for difficult-to-treat diseases, including cancer, inflammation, and autoimmune diseases [1][5]. - The company utilizes proprietary technologies, such as Azymetric™, to engineer and develop differentiated antibody-based therapeutic candidates [5]. Clinical Development Update - The decision to halt ZW171's development was based on the completion of planned cohorts in the Phase 1 trial, where a maximum tolerated dose was established, but dose-limiting toxicities were observed [3]. - Ongoing participants in the trial will continue treatment at the discretion of their investigators, while those who have discontinued will undergo safety follow-up as per the study protocol [3]. Future Pipeline - Despite the setback with ZW171, Zymeworks is advancing its broader product pipeline, including the ongoing Phase 1 trial of ZW191 and the expected initiation of a Phase 1 study for ZW251 in 2025 [4]. - The company is also preparing an IND filing for ZW209, a DLL3-directed trispecific T cell engager, planned for the first half of 2026 [4]. Product Achievements - Zymeworks has developed zanidatamab, a HER2-targeted bispecific antibody, which has received accelerated approval from the U.S. FDA and conditional approvals in China and Europe for treating specific cancer types [5]. - Zanidatamab is being evaluated in multiple global clinical trials as a potential best-in-class treatment for various HER2-expressing cancers [5]. Strategic Partnerships - The company has entered into agreements with BeOne Medicines Ltd. and Jazz Pharmaceuticals, granting them exclusive rights to develop and commercialize zanidatamab in different territories [5].
Zymeworks(ZYME) - 2025 Q2 - Earnings Call Presentation
2025-08-07 20:30
Financial Performance & Partnerships - Recognized approximately $75 million in 2025, including around $45 million from partnership-related cash milestones and option exercise fees, which significantly reduced net operating cash burn in the first half of 2025 compared to the first half of 2024[12] - Milestone, option exercise, and related deferred revenue of $45.8 million recognized in 2Q 2025 from BeOne and BMS[16, 17] - Potential future milestone payments from existing partnerships could reach up to $6.1278 billion, with royalty rates varying from low single-digit percentages to 20% depending on the partner and therapeutic indication[13] - Cash, cash equivalents, and marketable securities totaled $324.2 million in 2Q 2025, an increase of $9.2 million year-to-date, benefiting from milestone revenues and favorable working capital movements[16, 17] Clinical Development Updates - Investigational New Drug (IND) application cleared for ZW251, with first-in-human studies planned to start in 2025[11, 12, 47] - Phase 2 trial initiated to evaluate zanidatamab in HER2+ neoadjuvant and adjuvant breast cancer[12] - Bristol Myers Squibb collaboration progresses with a $7.5 million option exercise payment to Zymeworks[12] - ZW171: Global Phase 1 study in MSLN-Expressing Solid Tumors (NCT06523803) is an open-label, FIH, dose-escalation study (N~160)[19] - ZW191: Global Phase 1 Study in FRα-Expressing Solid Tumors (NCT06555744) is an open-label, FIH, dose-escalation study (N~145)[24] Zanidatamab Regulatory & Clinical Progress - NMPA granted BeOne conditional approval of zanidatamab in China for BTC, resulting in a $20 million payment to Zymeworks[12] - EMA granted conditional marketing approval of zanidatamab in Europe for BTC, expanding patient access and potential future royalties payable to Zymeworks[12, 47] - Jazz presented encouraging overall survival (OS) data for zanidatamab in 1L HER2+ GEA at the ASCO Annual Congress, showing a median OS of 36.5 months[12]
Zymeworks Provides Corporate Update and Reports Second Quarter 2025 Financial Results
Globenewswire· 2025-08-07 20:05
Core Insights - Zymeworks Inc. reported financial results for Q2 2025, highlighting significant revenue growth and advancements in its clinical pipeline, particularly with its lead product zanidatamab [1][16]. Financial Performance - Total revenue for Q2 2025 was $48.7 million, a substantial increase from $19.2 million in Q2 2024, driven by milestone payments and deferred revenue recognition [16]. - Research and Development (R&D) expenses rose to $34.4 million in Q2 2025 from $29.2 million in Q2 2024, reflecting increased investment in various clinical programs [16]. - The company achieved a net income of $2.3 million in Q2 2025, a significant turnaround from a net loss of $37.7 million in Q2 2024 [16][21]. Clinical Developments - Zymeworks has three product candidates expected to enter active Phase 1 trials in the second half of 2025, with two additional candidates on track for 2026 [2]. - The IND application for ZW251 was cleared by the FDA, with first-in-human studies planned for 2025 [3][7]. - Zanidatamab has shown promising results in clinical trials, with a median progression-free survival of 15.2 months and overall survival of 36.5 months in patients with HER2-positive gastroesophageal adenocarcinoma [9][10]. Strategic Partnerships - The company has established strategic partnerships that have validated its Azymetric platform, generating meaningful revenue and supporting clinical development [2]. - Zymeworks recognized $20 million in milestone revenue from BeOne Medicines related to the conditional approval of zanidatamab in China [10]. - The collaboration with Jazz Pharmaceuticals for zanidatamab is expected to enhance future royalties, with the European Commission granting conditional marketing authorization for the treatment of HER2-positive biliary tract cancer [11]. Cash Position - As of June 30, 2025, Zymeworks had cash resources of $333.4 million, providing a projected cash runway into the second half of 2027 [3][16].