Core Insights - Merck announced positive topline results from the Phase 3 KEYNOTE-B15 trial for patients with muscle-invasive bladder cancer (MIBC) eligible for cisplatin-based chemotherapy [1] - The trial evaluated the combination of KEYTRUDA® (pembrolizumab) and Padcev® (enfortumab vedotin-ejfv) as neoadjuvant and adjuvant treatment, showing statistically significant results [1] Company Summary - Merck, known as MSD outside the United States and Canada, is focusing on innovative cancer treatments [1] - The positive results from the KEYNOTE-B15 trial may enhance Merck's position in the oncology market [1] Industry Summary - The trial results contribute to the growing body of evidence supporting immunotherapy and targeted therapy combinations in treating bladder cancer [1] - The findings may influence treatment protocols and patient outcomes in the field of oncology [1]

Designation underscores the potential of SAFEbody®-enabled anti-CTLA-4 therapy to address unmet need in MSS colorectal cancer SAN DIEGO and SUZHOU, China, Dec. 16, 2025 (GLOBE NEWSWIRE) -- Adagene Inc. (“Adagene”) (Nasdaq: ADAG), a company transforming the discovery and development of novel antibody-based therapies, today announced that the U.S. Food and Drug Administration (FDA) has designated muzastotug, in combination with Merck’s (known as MSD outside of the United States and Canada) anti-PD-1 therapy, ...

Company Presentation & KOL Webinar MDNA11 Clinical Data Update 10 December 2025 ESMO-IO Congress 2025 Disclaimer Certain statements in this presentation may constitute "forward-looking statements" under applicable securities laws. These forward-looking statements include, but are not limited to, information about possible or assumed future results of the Medicenna Therapeutics Corp's (the "Company" or "Medicenna") business, clinical trials, drug development, financial condition, results of operations, liqui ...

Core Points - Merck will participate in the 8th Annual Evercore ISI HealthCONx Conference on December 2, 2025, featuring Chirfi Guindo and Dr. Eliav Barr [1] - A live audio webcast of the presentation will be available for investors, analysts, and the public [2] - Merck aims to be a leading research-intensive biopharmaceutical company, focusing on innovative health solutions and a diverse workforce [3] Company Overview - Merck, known as MSD outside the U.S. and Canada, has over 130 years of experience in developing important medicines and vaccines [3] - The company is committed to advancing clinical research in hematology and has an expanding pipeline of investigational candidates [7]

Core Viewpoint - Merck has received FDA approval for KEYTRUDA and KEYTRUDA QLEX in combination with Padcev for the treatment of muscle-invasive bladder cancer in adult patients [1] Group 1 - The FDA approved KEYTRUDA (pembrolizumab) as a neoadjuvant treatment and continued as adjuvant treatment after cystectomy for muscle-invasive bladder cancer [1] - KEYTRUDA QLEX, a combination of pembrolizumab and berahyaluronidase alfa-pmph, has also been approved for the same indication [1] - The treatment is specifically for adult patients diagnosed with muscle-invasive bladder cancer (MIBC) [1]

Core Points - The European Commission has approved a new subcutaneous administration route and a new pharmaceutical form of KEYTRUDA, Merck's anti-PD-1 therapy [1] Company Summary - Merck, known as MSD outside the U.S. and Canada, will market the new formulation as KEYTRUDA SC in the European Union [1] - In the U.S., the product will be marketed as KEYTRUDA QLEX, which combines pembrolizumab and berahyaluronidase alfa-pmph [1]

Core Insights - Evaxion A/S has presented new data on its AI-designed personalized cancer vaccine EVX-01 at the Society for Immunotherapy of Cancer (SITC) 2025 Annual Meeting, highlighting immune responses following treatment [1][8] - The vaccine targets multiple neoantigens and aims to induce a clinically relevant immune response, particularly in patients with advanced melanoma when combined with MSD's KEYTRUDA® [2][4] Company Overview - Evaxion is a clinical-stage TechBio company that utilizes its AI-Immunology™ platform to develop innovative vaccines for cancer and infectious diseases [6] - The company is focused on transforming patient care through targeted treatment options, leveraging AI to decode the human immune system [6] Clinical Data - The new biomarker and immune data presented is derived from a phase 2 trial of EVX-01 in combination with KEYTRUDA®, showing promising immune responses in patients [2][8] - Longitudinal blood samples were analyzed to understand treatment-induced changes in immune cell populations, revealing a rapid and sustained induction of EVX-01-specific T-cells in some patients [3] Market and Community Response - The presentation of the new data at SITC follows the recent disclosure of two-year clinical efficacy data from the same phase 2 trial, indicating strong interest from the medical community [4][8]

Core Insights - CytomX Therapeutics is advancing its pipeline with a focus on CX-2051 and CX-801, with key updates expected in 2026 [1][2][3] Pipeline Developments - CX-2051 Phase 1 data update is scheduled for Q1 2026, with ongoing dose expansions in advanced colorectal cancer (CRC) [1][5] - A Phase 1b study combining CX-2051 with bevacizumab is set to begin in Q1 2026, aimed at informing late-phase development [5] - CX-801 has shown positive initial biomarker data in advanced melanoma, supporting its combination study with KEYTRUDA® [3][5] Financial Performance - As of September 30, 2025, the company reported cash, cash equivalents, and investments totaling $143.6 million, down from $158.1 million as of June 30, 2025 [7] - Total revenue for Q3 2025 was $6.0 million, a significant decrease from $33.4 million in Q3 2024, primarily due to the completion of obligations in collaborations [8] - Total operating expenses decreased to $21.7 million in Q3 2025 from $29.3 million in Q3 2024, with research and development expenses at $15.3 million [8][9] Corporate Updates - The company appointed Rachael Lester as Senior Vice President and Chief Business Officer in October 2025 [11] - CytomX has established collaborations with major companies in oncology, including Bristol Myers Squibb, Amgen, and Moderna, focusing on bispecific immunotherapies [11][12]

Core Insights - Pyxis Oncology is advancing its lead candidate, micvotabart pelidotin (MICVO), targeting recurrent and metastatic head and neck squamous cell carcinoma (R/M HNSCC) with preliminary data expected in Q4 2025 [1][5] Pipeline & Clinical Updates - Ongoing Phase 1 clinical studies of MICVO include monotherapy and combination approaches, with a focus on 2L/3L R/M HNSCC patients and a collaboration with Merck for combination therapy with KEYTRUDA® [4][5] - Preliminary data from the Phase 1 monotherapy dose expansion study and the Phase 1/2 combination dose escalation study will be presented, highlighting MICVO's unique mechanism of action and its potential to improve treatment outcomes [4][5] - Recent translational data presented at ESMO 2025 and AACR-NCI-EORTC provided insights into MICVO's pharmacodynamics and its effects on tumor microenvironment remodeling and immune activation [4][5] Financial Results - As of September 30, 2025, Pyxis Oncology reported cash and cash equivalents of $77.7 million, sufficient to fund operations into the second half of 2026 [11] - Research and development expenses for Q3 2025 were $17.8 million, slightly up from $17.7 million in Q3 2024, with a notable increase in MICVO program-specific costs [11] - The net loss for Q3 2025 was $22.0 million, consistent with the previous year, reflecting ongoing investment in clinical development [11][14]

Core Viewpoint - The European Commission has approved Merck's KEYTRUDA® for the treatment of resectable locally advanced head and neck squamous cell carcinoma, marking a significant advancement in cancer therapy [1] Group 1: Approval Details - KEYTRUDA® (pembrolizumab) is approved as a monotherapy for neoadjuvant treatment of locally advanced head and neck squamous cell carcinoma [1] - The treatment will continue as adjuvant therapy in combination with radiation therapy, with or without concomitant cisplatin [1] - Following the combination therapy, KEYTRUDA® will be administered as a monotherapy in adults [1]