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]

RAHWAY, N.J .--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA® (pembrolizumab) and KEYTRUDA QLEXâ,ç¢ (pembrolizumab and berahyaluronidase alfa-pmph) in combination with Padcev® (enfortumab vedotin-eifv), as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment, for the treatment of adult patients with muscle-invasive bladder cancer (MIBC) who ar. ...

RAHWAY, N.J.--(BUSINESS WIRE)---- $MRK #MRK--Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the European Commission (EC) has approved a new subcutaneous (SC), or under the skin, route of administration and a new pharmaceutical form (solution for injection) of KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy. KEYTRUDA SC™, as it will be marketed in the European Union (EU), [known as KEYTRUDA QLEXTM (pembrolizumab and berahyaluronidase alfa-pmph) in the U.S.] ...

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]

RAHWAY, N.J.--(BUSINESS WIRE)---- $MRK #MRK--Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the European Commission (EC) has approved KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, as monotherapy for the treatment of resectable locally advanced head and neck squamous cell carcinoma (LA-HNSCC) as neoadjuvant treatment, continued as adjuvant treatment in combination with radiation therapy with or without concomitant cisplatin and then as monotherapy in adu ...

CAMBRIDGE, Mass., Oct. 21, 2025 (GLOBE NEWSWIRE) -- Flare Therapeutics Inc. (FlareTx), a clinical-stage biotechnology company targeting transcription factors to discover precision medicines for oncology and other therapeutic areas, today announced that it has entered into a clinical trial collaboration and supply agreement with Merck (known as MSD outside of the United States and Canada). FX-909, a first-in-class orally available small molecule inhibitor of PPARG, the master regulator of the luminal lineage ...

Core Insights - Immutep Limited announced positive results from the EFTISARC-NEO Phase II trial, demonstrating significant efficacy of eftilagimod alfa (efti) in combination with radiotherapy and KEYTRUDA® for resectable soft tissue sarcoma (STS) [1][5] - The trial met its primary endpoint, achieving a median tumor hyalinization/fibrosis of 51.5%, significantly exceeding the prespecified target of 35% [1][5] - The results indicate a potential for improved overall survival and recurrence-free survival in STS patients, addressing a substantial unmet medical need in this area [2][5] Company Overview - Immutep is a late-stage biotechnology company focused on developing novel immunotherapies for cancer and autoimmune diseases, particularly leveraging LAG-3 [7] - The company aims to provide innovative treatment options and maximize shareholder value through its diversified product portfolio [7] Clinical Trial Details - The EFTISARC-NEO Phase II trial was investigator-initiated and involved a diverse population of STS subtypes, showcasing a robust safety profile with minimal severe toxicity [1][2] - The study was primarily funded by a grant from the Polish government through the Polish Medical Research Agency program [2] Eftilagimod Alfa (Efti) Mechanism - Efti is an MHC Class II agonist that activates antigen-presenting cells, stimulating both adaptive and innate immune responses to combat cancer [4][6] - The therapy is under evaluation for various solid tumors, including non-small cell lung cancer and head and neck squamous cell carcinoma, with favorable safety allowing for multiple combination therapies [6]

Core Insights - BT-001, in combination with pembrolizumab, demonstrates good tolerability and sustained antitumoral activity in both injected and non-injected lesions, supporting further development in solid tumors to enhance cancer immunotherapy responses [1][5][6] Clinical Results - Intra-tumoral injection of BT-001 combined with KEYTRUDA® (pembrolizumab) showed positive local, abscopal, and sustained antitumoral activity [2] - Significant tumor shrinkage (≥30% decrease in longest diameter) was observed in five of 16 injected lesions across three melanoma patients and one sarcoma patient, with four patients experiencing shrinkage in non-injected lesions [3] - Long-lasting partial responses were noted in a melanoma patient resistant to anti-PD-1/anti-CTLA-4 therapy and a heavily pre-treated, PD-L1 negative leiomyosarcoma patient [4] Mechanism of Action - The immune-mediated tumor shrinkages align with the hypothesis that BT-001, in combination with pembrolizumab, can convert "cold" tumors into immunologically active ones [5] - BT-001 is designed to induce a strong anti-tumor response by expressing GM-CSF and an anti-CTLA-4 antibody, potentially expanding treatment options with a favorable safety profile [6][11] Company Statements - Transgene and BioInvent are co-developing BT-001, which utilizes Transgene's Invir.IO® platform to enhance replication selectivity in tumor cells and express an anti-CTLA-4 antibody [6][12] - The companies aim to continue exploring the safety and efficacy of BT-001, with ongoing clinical trials evaluating its use alone and in combination with pembrolizumab [11][12]