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Jazz Pharmaceuticals Showcases Transformative Data at ASCO 2025, Highlighting Advances in Small Cell Lung Cancer, HER2+ Gastroesophageal Cancer and Diffuse Glioma
Prnewswire· 2025-04-23 20:15
Core Insights - Jazz Pharmaceuticals is presenting significant clinical trial data at the ASCO Annual Meeting, highlighting the potential of Zepzelca® (lurbinectedin) in combination with atezolizumab (Tecentriq®) for first-line maintenance therapy in extensive-stage small cell lung cancer (ES-SCLC) [1][2] - The company is also showcasing long-term outcomes for Ziihera® (zanidatamab-hrii) in HER2-positive gastroesophageal cancer, indicating its potential to change treatment paradigms [1][2] - Efficacy and safety data for dordaviprone (ONC201) in recurrent H3 K27M-mutant diffuse glioma patients are also being presented, addressing a significant unmet medical need [1][2] Group 1: Zepzelca® (lurbinectedin) - The Phase 3 IMforte trial data shows statistically significant and clinically meaningful progression-free survival (PFS) and overall survival (OS) for Zepzelca in combination with atezolizumab for ES-SCLC patients [2][4] - The FDA has received a supplemental New Drug Application based on this trial data, marking a milestone for Zepzelca's approval process [2][4] - An investor webcast is scheduled for June 10 to review Zepzelca data, featuring commentary from experts [3] Group 2: Ziihera® (zanidatamab-hrii) - Updated long-term outcomes and median overall survival findings from the Phase 2 trial of Ziihera in combination with chemotherapy for HER2-positive metastatic gastroesophageal adenocarcinoma will be presented [2][4] - Ziihera is positioned as a differentiated HER2-targeted therapy, with further Phase 3 findings expected later this year [2][4] Group 3: Dordaviprone (ONC201) - New efficacy and safety findings for dordaviprone in adult and pediatric patients with recurrent H3 K27M-mutant diffuse glioma are being highlighted [2][4] - The drug addresses a significant unmet need, as there are currently no FDA-approved therapies for this patient population [2][4] Group 4: Company Overview - Jazz Pharmaceuticals is committed to advancing targeted treatment options that address pressing patient needs, with a focus on oncology and neuroscience [55] - The company has a diverse portfolio of marketed medicines and is dedicated to developing potentially life-changing therapies for serious diseases [55]
Zymeworks to Report First Quarter 2025 Financial Results and Host Conference Call on May 8, 2025
Newsfilter· 2025-04-17 10:00
Core Viewpoint - Zymeworks Inc. is a clinical-stage biotechnology company focused on developing novel biotherapeutics for challenging diseases, including cancer, inflammation, and autoimmune diseases, with an upcoming financial results announcement and corporate update scheduled for May 8, 2025 [1][2]. Company Overview - Zymeworks is dedicated to the discovery, development, and commercialization of multifunctional biotherapeutics, aiming to significantly impact the lives of patients with difficult-to-treat conditions [3]. - The company has developed zanidatamab, a HER2-targeted bispecific antibody utilizing proprietary Azymetric™ technology, and has secured exclusive development and commercialization agreements with BeiGene and Jazz Pharmaceuticals [3]. - Ziihera® (zanidatamab-hrii) has received accelerated approval from the U.S. FDA for treating adults with previously-treated, unresectable or metastatic HER2-positive second-line biliary tract cancer, marking it as the first dual HER2-targeted bispecific antibody approved for this indication in the U.S. [3]. - Zanidatamab is under regulatory review in the EU and China and is being evaluated in global clinical trials for various HER2-expressing cancers [3]. - Zymeworks is advancing a robust pipeline of product candidates, with ongoing Phase 1 studies for ZW171 and ZW191, and plans for an investigational new drug application for ZW251 in mid-2025 [3]. Upcoming Events - The company will report its first quarter 2025 financial results after market close on May 8, 2025, followed by a conference call and webcast at 4:30 pm Eastern Time [1].
AMGEN ANNOUNCES 2025 SECOND QUARTER DIVIDEND
Prnewswire· 2025-03-04 21:54
Core Points - Amgen's Board of Directors declared a dividend of $2.38 per share for Q2 2025, payable on June 6, 2025, to stockholders of record as of May 16, 2025 [1] Company Overview - Amgen is a biotechnology company that discovers, develops, manufactures, and delivers innovative medicines for various diseases, leveraging over 40 years of industry experience [2] - The company has a broad pipeline aimed at treating cancer, heart disease, osteoporosis, inflammatory diseases, and rare diseases [2] Recognition and Market Position - In 2024, Amgen was recognized as one of the "World's Most Innovative Companies" by Fast Company and one of "America's Best Large Employers" by Forbes [3] - Amgen is part of the Dow Jones Industrial Average and the Nasdaq-100 Index, highlighting its status as one of the largest and most innovative non-financial companies [3]
BeiGene: Q4 Results Impress With Positive Earnings Expected In 2025
Seeking Alpha· 2025-02-28 19:00
Core Insights - The article highlights BeiGene, Ltd. (NASDAQ: ONC) as a strong buy due to the approval of Tevimbra in Europe and the US, indicating significant growth potential for the company [1] Company Overview - BeiGene has recently received approval for its drug Tevimbra, which is expected to drive growth [1] - The company has a strong foundation with its co-founder having extensive experience in both major pharmaceutical companies and biotech startups [1] Investment Perspective - The author expresses a beneficial long position in the shares of ONC, indicating confidence in the company's future performance [2]
BeiGene (ONC) Q4 Earnings: Taking a Look at Key Metrics Versus Estimates
ZACKS· 2025-02-27 15:35
Core Insights - BeiGene, Ltd. reported a revenue of $1.13 billion for the quarter ended December 2024, marking a 77.8% increase year-over-year and exceeding the Zacks Consensus Estimate of $1.09 billion by 3.76% [1] - The company's EPS was -$1.43, an improvement from -$3.53 in the same quarter last year, but fell short of the consensus estimate of -$0.88, resulting in a surprise of -62.50% [1] Revenue Breakdown - Product revenue reached $1.12 billion, surpassing the average estimate of $1.08 billion by analysts, reflecting a 77.3% increase compared to the previous year [4] - BRUKINSA (Zanubrutinib) generated $828.03 million, exceeding the average estimate of $764.99 million [4] - Tislelizumab revenue was $153.80 million, below the average estimate of $174.58 million [4] - REVLIMID revenue was $3.56 million, significantly lower than the estimated $10.17 million [4] - Other product revenues included $18.24 million for Other, $62.52 million for XGEVA, $13.11 million for POBEVCY, $20.62 million for BLINCYTO, and $18.15 million for KYPROLIS, with most figures falling short of analyst estimates [4] - Collaboration revenue was reported at $9.79 million, exceeding the average estimate of $6.22 million, representing a 152.1% increase year-over-year [4] Stock Performance - Over the past month, BeiGene's shares have returned +14.2%, contrasting with a -2.2% change in the Zacks S&P 500 composite [3] - The stock currently holds a Zacks Rank 3 (Hold), indicating potential performance in line with the broader market in the near term [3]