NEW YORK & TOKYO--(BUSINESS WIRE)--Pfizer Inc. (NYSE: PFE) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas†) today announced positive results from the Phase 3 EV- 304 clinical trial (also known as KEYNOTE-B15) for PADCEVTM (enfortumab vedotin), a Nectin-4 directed antibody-drug conjugate, in combination with Keytruda® (pembrolizumab), a PD-1 inhibitor, in patients with muscle-invasive bladder cancer (MIBC) eligible for cisplatin-based chemotherapy. Perioperative. ...

This week, the biotech space witnessed significant milestones, including FDA approvals, oncology drug acquisitions, and collaborations. Positive clinical trial results were reported across multiple therapeutic areas, including radiographic and non-radiographic axial spondyloarthritis, microcystic lymphatic malformations, pulmonary arterial hypertension, and obesity. Here's a closer look at the details. FDA Approvals & Rejections Armata Pharma Secures FDA QIDP Designation for AP-SA02 Armata Pharmaceuticals, ...

Core Insights - Astellas Pharma and Vir Biotechnology have entered a global strategic collaboration to co-develop and commercialize VIR-5500, a dual-masked T-cell engager targeting PSMA for prostate cancer treatment [1][2] - The collaboration aims to enhance Astellas' oncology pipeline and leverage both companies' expertise in advancing therapies for prostate cancer [1][2] Financial Terms - Vir Biotechnology will receive $335 million in upfront and near-term milestone payments, including $240 million in cash, $75 million in equity investment at a 50% premium, and a near-term $20 million milestone [1][2] - The companies will share global development costs for VIR-5500, with Astellas covering 60% and Vir Biotechnology 40% [1] - Vir Biotechnology is eligible for up to $1.37 billion in additional development, regulatory, and sales milestones, along with tiered, double-digit royalties on ex-U.S. net sales [1][2] Development and Commercialization - Astellas will lead the commercialization of VIR-5500 in the U.S., while retaining exclusive rights to commercialize the product outside the U.S. [1] - Vir Biotechnology will continue the ongoing Phase 1 trial until responsibility transitions to Astellas, which will then handle all development activities [1][2] - The collaboration is expected to accelerate the advancement of VIR-5500, potentially benefiting more patients with prostate cancer [1][2] Market Context - Prostate cancer, particularly metastatic castration-resistant prostate cancer (mCRPC), remains challenging to treat, with a 5-year survival rate of approximately 30% [1] - VIR-5500 is positioned as a potentially best-in-class treatment option, utilizing PRO-XTEN® masking technology to reduce off-target effects [1][2]

Core Insights - Astellas Pharma Inc. will present at the 44th Annual J.P. Morgan Healthcare Conference, highlighting its strategic focuses and progress in delivering long-term impact for patients, partners, and shareholders [1][2] Company Strategy and Leadership - President and CEO Naoki Okamura will discuss Astellas' key growth drivers and commitment to disciplined execution, while Chief Research & Development Officer Tadaaki Taniguchi will emphasize advancements in transformative scientific breakthroughs for diseases with high unmet medical needs [2][3] - The company aims to turn innovative science into meaningful value for patients and drive sustainable growth, using the conference as a platform to engage with the global investment and healthcare community [3] Event Details - The presentation will take place on January 12, 2026, at 3:00 p.m. PT at the Westin St. Francis, San Francisco, with materials and a live webcast available on Astellas' Investor Relations page [8] Industry Engagement - Astellas is also a distinguished sponsor of the Biotech Showcase, further enhancing its visibility in the global life sciences community, with Chief Strategy Officer Adam Pearson participating in discussions on partnering trends that advance emerging technologies and drug development innovation [4]

Core Insights - Astellas Pharma and Pfizer announced positive topline results from the Phase 3 EV-304 clinical trial for PADCEV in combination with Keytruda, showing significant improvements in event-free survival and overall survival for muscle-invasive bladder cancer patients [1][5][7] Company Insights - Astellas Pharma is focused on advancing treatment options for muscle-invasive bladder cancer, with recent findings reinforcing the potential of PADCEV plus pembrolizumab to improve survival outcomes for a broad patient population [4][5] - Pfizer emphasizes the significance of the EV-304 results, indicating a potential shift in the standard of care for muscle-invasive bladder cancer patients, particularly those ineligible for platinum-based chemotherapy [5][6] Industry Insights - Muscle-invasive bladder cancer is a significant health concern, with nearly half of patients progressing to metastatic disease within three years of diagnosis, highlighting the need for effective treatment options [3][6] - The EV-304 trial results may lead to a new standard of care in bladder cancer treatment, moving away from conventional platinum-based chemotherapy [5][7]

Core Insights - Astellas Pharma is set to present new data on potential treatments for pancreatic and gastric/gastroesophageal junction (G/GEJ) cancer at the 2026 ASCO GI Cancers Symposium, highlighting advancements in precision oncology and the company's commitment to improving patient outcomes [1][2]. Company Developments - Astellas will showcase results from the Phase 2 ILUSTRO study, which evaluates the efficacy of zolbetuximab in combination with chemotherapy and immunotherapy for treating claudin 18.2-positive, HER2-negative, locally advanced or metastatic G/GEJ cancer [1][3]. - The company is also advancing ASP3082 (setidegrasib), a targeted protein degrader for KRAS G12D mutations, currently in Phase 1 trials for pancreatic cancer [1][4]. Presentation Details - Key presentations at the ASCO GI 2026 include: - Oral presentation of the Phase 2 ILUSTRO trial results on January 8, 2026, focusing on zolbetuximab plus mFOLFOX6 and nivolumab [3]. - Poster presentations on various topics, including biomarker testing and treatment selection for gastric or GEJ adenocarcinoma [3][4]. Product Information - VYLOY (zolbetuximab) is a first-in-class monoclonal antibody targeting claudin 18.2, currently the only approved treatment for CLDN18.2-positive (HER2-negative) gastric or GEJ cancer in several regions, including the U.S. and Europe [7][8]. - ASP3082 (setidegrasib) targets KRAS G12D mutations, which are present in approximately 40% of pancreatic ductal adenocarcinomas, and is being evaluated for its safety and efficacy in clinical trials [12].

Core Insights - Astellas Pharma is presenting new data on gilteritinib for FLT3m+ acute myeloid leukemia (AML) at the American Society of Hematology (ASH) Annual Meeting, focusing on various treatment settings including relapsed or refractory cases and post-transplant maintenance [1][2] Group 1: Research and Development - Ongoing research with gilteritinib aims to improve long-term outcomes for patients with FLT3m+ AML, particularly in challenging cases characterized by high treatment failure rates [2] - The Phase 3 ADMIRAL and COMMODORE trials provide pooled post-hoc analysis on gilteritinib's effectiveness in relapsed or refractory FLT3m+ AML, emphasizing treatment sequencing and resumption post-transplant [4] - The Phase 1/2 VICEROY study is investigating a triplet combination therapy approach with gilteritinib for newly diagnosed FLT3m+ AML patients who are ineligible for intensive chemotherapy, focusing on safety and efficacy [4] Group 2: Presentations at ASH 2025 - Key presentations include outcomes of patients who resumed gilteritinib therapy after hematopoietic stem cell transplant (HSCT) and interim results from the VICEROY study [3][5] - A presentation will discuss the impact of pre-HCT FLT3 inhibition on minimal residual disease (MRD) and the benefits of post-HCT gilteritinib [5] - Additional studies will cover the long-term follow-up of azacitidine, venetoclax, and gilteritinib in newly diagnosed FLT3-mutated AML patients [6] Group 3: Product Information - Gilteritinib, marketed as XOSPATA, is an FLT3 inhibitor effective against FLT3-ITD and FLT3-TKD mutations, which are associated with poor prognosis in AML [8][10] - XOSPATA is available globally, including in the U.S., Japan, China, and several European countries, for adult patients with relapsed or refractory FLT3m+ AML [8][13]

Core Viewpoint - Pfizer Inc. is hosting a conference call on December 16, 2025, to provide financial guidance for the full year of 2026, inviting both investors and the public to participate [1][2]. Group 1: Conference Call Details - The conference call will take place at 8:00 a.m. EST and will be accessible via a webcast on Pfizer's investor website [1][2]. - Participants are encouraged to register in advance for the conference call, with dial-in options provided for both U.S. and international attendees [2]. - A transcript and replay of the call will be available on Pfizer's website within 24 hours and accessible for at least 90 days [3]. Group 2: Company Overview - Pfizer is committed to applying science and global resources to develop therapies that significantly improve patients' lives, focusing on quality, safety, and value in healthcare products [4]. - The company collaborates with healthcare providers, governments, and communities to enhance access to affordable healthcare worldwide [4]. - Pfizer has a long history of 175 years in the biopharmaceutical industry, emphasizing its role in advancing wellness and combating serious diseases [4].

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Core Insights - The U.S. FDA has approved PADCEV® (enfortumab vedotin-ejfv) in combination with Keytruda® (pembrolizumab) or Keytruda QLEX™ for neoadjuvant treatment followed by continued use after cystectomy [1] Company Developments - Pfizer Inc. and Astellas Pharma Inc. jointly announced the FDA approval of PADCEV® [1] - The approval marks a significant advancement in treatment options for patients undergoing cystectomy [1] Industry Impact - The combination therapy of PADCEV® and Keytruda® represents a new approach in the oncology sector, particularly for bladder cancer treatment [1] - This approval may enhance competitive positioning for both Pfizer and Astellas in the immuno-oncology market [1]