Regeneron Announces Investor Conference Presentations

On November 3, 2025 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported it will webcast management participation as follows:

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Jefferies London Healthcare Conference at 3:30 p.m. GMT (10:30 a.m. ET) on Monday, November 17, 2025
7th Annual Wolfe Research Healthcare Conference at 9:20 a.m. ET on Monday, November 17, 2025
8th Annual Evercore Healthcare Conference at 1:20 p.m. ET on Tuesday, December 2, 2025
Citi 2025 Global Healthcare Conference at 10:30 a.m. ET on Wednesday, December 3, 2025

The sessions may be accessed from the "Investors & Media" page of Regeneron’s website at View Source Replays and transcripts of the webcasts will be archived on the Company’s website for at least 30 days.

(Press release, Regeneron, NOV 3, 2025, View Source [SID1234659278])

Recordati Rare Diseases to Share New Data at the American Society of Hematology (ASH) Meeting

On November 3, 2025 Recordati Rare Diseases Inc. reported the presentation of new data related to its growing portfolio of treatments for rare hematologic disorders at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, which takes place December 6-9, 2025, in Orlando, Fla. In a series of nine poster presentations, Recordati researchers and independent investigators will present research detailing advances in Castleman disease (CD), cold agglutinin disease (CAD)/cold agglutinin syndrome (CAS), and immune-related complications of CAR T-cell therapy. Highlights include a report on the development of an artificial intelligence (AI) model that evaluates CD tissue samples; an analysis of the morbidity burden and healthcare costs among patients with idiopathic multicentric Castleman disease (iMCD); the first real-world evaluation of sutimlimab in the treatment of patients with CAD or CAS; and a prospective evaluation of siltuximab in the prevention or treatment of cytokine release syndrome (CRS) after CAR T-cell therapy.

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"We are particularly excited about the long-term safety data for sutimlimab in cold agglutinin disease and the growing body of research investigating the use of siltuximab in Castleman disease," said Milan Zdravkovic, Executive Vice President, Research & Development and Chief Medical Officer at Recordati. "Also notable is the poster describing an innovative, AI-based approach to lymph node analysis, which could represent a meaningful step toward earlier and more consistent diagnosis of Castleman disease, one of the most difficult hematologic conditions to diagnose accurately. Altogether, the datasets presented at ASH (Free ASH Whitepaper) 2025 reflect Recordati’s ongoing commitment to advancing care for people living with rare hematologic disorders."

"The ASH (Free ASH Whitepaper) Annual Meeting is an important opportunity to showcase research advances in hematologic diseases, and we are pleased that the meeting organizers have accepted nine abstracts related to our therapies," said Mohamed Ladha, President and General Manager at Recordati Rare Diseases North America. "Together with our independent research partners, Recordati is at the forefront of advancing potential therapeutic solutions for people living with devastating conditions such as Castleman disease. We look forward to these data sparking further dialogue and collaboration as we continue in our efforts to improve patients’ lives."

The ASH (Free ASH Whitepaper) 2025 Annual Meeting will feature the following poster presentations:

Castleman Disease

Poster number: 2606
Title: Retrospective real-world data analysis of morbidity burden and healthcare costs in idiopathic multicentric Castleman disease compared with matched controls (BURDEN-iMCD)
Presenting author: Sudipto Mukherjee, MD, PhD, MPH, Cleveland Clinic

Poster number: 3001
Title: Comprehensive analysis of subtype-specific outcomes and management in Castleman disease: a 20-year cohort study
Presenting author: Yoshito Nishimura, MD, PhD, MPH, Mayo Clinic

Poster number: 3002
Title: Automated grading of Castleman disease histopathology using an attention-based multiple-instance learning model
Presenting author: Muir Morrison, PhD, University of Utah

Poster number: 3009
Title: Pediatric idiopathic multicentric Castleman disease is often severe and responds to siltuximab
Presenting author: Bridget Austin, MS, Perelman School of Medicine, University of Pennsylvania, Center for Cytokine Storm Treatment & Laboratory

Poster number: 3006
Title: Epidemiology and clinical characteristics of idiopathic multicentric Castleman disease in Spain (ARCANA study): Prevalence cohort
Presenting author: José-Tomás Navarro, MD, PhD, Catalan Institute of Oncology, Josep Carreras Leukaemia Research Institute

Poster number: 4788
Title: Siltuximab-mediated suppression of CRP is associated with clinical response in idiopathic multicentric Castleman disease
Presenting author: Jean-Francois Rossi, MD, PhD, Université de Montpellier

Cold Agglutinin Disease (CAD)

Poster number: 6242
Title: Real-world safety of sutimlimab in patients with CAD/CAS: a multinational, multicenter, observational, prospective cohort study
Presenting author: Alexander Röth, MD, West German Cancer Center, University Hospital Essen, University of Duisburg-Essen

CAR T-Cell Therapy Toxicity (including in B-Cell Lymphoma)*

Poster number: 2385
Title: Safety and immunomodulatory effects of siltuximab prophylaxis prior to standard of care CD19 directed chimeric antigen receptor T-cell (CD19.CART) therapy for B-cell lymphomas: final Phase I trial results
Presenting author: Nathan Denlinger, DO, MS, The Ohio State University Wexner Medical Center, James Comprehensive Cancer Center

Poster number: 5919
Title: Siltuximab versus tocilizumab for the management of CAR T-cell associated cytokine release syndrome
Presenting author: Mayur Narkhede, MD, University of Alabama at Birmingham

*These studies were conducted as investigator-sponsored studies without research involvement by Recordati.

About Idiopathic Multicentric Castleman Disease (iMCD)
Idiopathic multicentric Castleman disease is a rare cytokine-driven disorder that may be life-threatening and can affect people of any age. Its symptoms often resemble those of malignant lymphoma, autoimmune, or infectious diseases, making it difficult to diagnose. iMCD is a subtype of Castleman disease (CD), which is a group of rare conditions that affect the immune system, characterized by swollen lymph nodes and a broad range of inflammatory signs and symptoms. The cause of iMCD is unknown, and there are no known risk factors. Some people with iMCD have elevated levels of interleukin 6 (IL-6), a cytokine that is produced in the body during inflammation and which plays a central pathological role in iMCD; IL-6 elevation may explain some of the symptoms patients experience, such as swollen lymph nodes, fever, unexplained weight loss, and night sweats.

About Cold Agglutinin Disease (CAD)
Cold agglutinin disease (CAD) is a rare type of autoimmune hemolytic anemia (AIHA), characterized as a low-grade lymphoproliferative disorder of the bone marrow. In CAD, autoantibodies bind to erythrocytes at temperatures ≤37°C, leading to complement-mediated hemolysis. CAD symptoms include severe, debilitating fatigue and other clinical manifestations (e.g., dyspnea, tachycardia) that can impact patients’ quality of life. While the median age of onset is approximately 60 years, CAD has been diagnosed in patients as young as 30.

(Press release, Recordati, NOV 3, 2025, View Source [SID1234659296])

Akeso’s Ivonescimab Secures Fourth Breakthrough Therapy Designation in China for First-Line Treatment of Triple-Negative Breast Cancer

On November 2, 2025 Akeso (9926.HK) reported that its first-in-class bispecific antibody, ivonescimab (PD-1/VEGF bispecific antibody), in combination with chemotherapy for first-line treatment of triple-negative breast cancer (TNBC) has been granted Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) from China’s National Medical Products Administration (NMPA).

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The Phase III multicenter, randomized, double-blind clinical trial (HARMONi-BC1/AK112-308) for this combination therapy is ongoing in China. The BTD designation is expected to further expedite the clinical development and regulatory approval process of ivonescimab for the treatment of TNBC. This marks the fourth BTD granted by the CDE for ivonescimab. The previous three designations include:

Ivonescimab combined with chemotherapy for locally advanced or metastatic NSCLC resistant to EGFR-TKI therapy, which has now been approved for marketing in China and added to China’s National Reimbursement Drug List.

First-line treatment of PD-L1-positive locally advanced or metastatic NSCLC, which has also been approved for marketing in China.

Ivonescimab combined with docetaxel for locally advanced or metastatic NSCLC patients who have failed previous PD-1/L1 inhibitors and platinum-based chemotherapy. The Phase III clinical trial for this indication in China is currently ongoing.
Receiving four Breakthrough Therapy Designations affirms ivonescimab’s substantial clinical benefit across multiple major cancer types and reinforces Akeso’s commitment to addressing critical unmet medical needs. The therapy is currently advancing in 14 Phase III clinical trials worldwide, including four international multicenter studies. These large pivotal studies, backed by repeated regulatory recognition, position ivonescimab to deliver transformative, life-saving outcomes for patients worldwide.

(Press release, Akeso Biopharma, NOV 2, 2025, View Source [SID1234659227])

OncoHost to Present Two Posters Highlighting Advances in Plasma Proteomics Monitoring and Prediction for NSCLC at ISLB 2025

On November 2, 2025 OncoHost, a global leader in precision oncology and proteomics-based biomarker development, reported the presentation of two new research posters at the 2025 International Society for Liquid Biopsy (ISLB) Annual Congress. The studies underscore the transformative potential of plasma proteomics in improving clinical decision-making and real-time disease monitoring for patients with non-small cell lung cancer (NSCLC).

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Poster 1: Plasma Proteomics as a Systemic Monitoring Approach in NSCLC Immunotherapy: Comparative Analysis with ctDNA

Presenter: Michal Harel, Ph.D., VP Translational Medicine, OncoHost
Presentation Time: Sunday, November 2, 10:45–11:45, Tuesday, November 3, 9:00-10:00

This study introduces a comparative analysis between plasma proteomic signatures and circulating tumor DNA (ctDNA) to evaluate immunotherapy response in advanced NSCLC.

Leveraging aptamer-based proteomic profiling of approximately 7,000 plasma proteins per sample, researchers identified three key proteomic signatures reflecting:

Soluble PD-1/PD-L1 drug bioavailability,
T-cell activation and immune engagement, and
Intracellular proteins indicating lung tissue damage.
Notably, the tissue-damage signature enabled early detection of non-responders up to 6.6 months before standard imaging. While ctDNA tumor load correlated modestly with this signature, only the proteomic analysis effectively distinguished clinical response groups.

"These results demonstrate the unique systemic insight offered by plasma proteomics – capturing the full tumor-immune interaction beyond what is achievable with ctDNA alone," said Dr. Harel. "This approach has the potential to revolutionize real-time treatment monitoring for immunotherapy patients."

Poster 2: A Plasma Proteomics Test Predicts Immunotherapy Benefit in NSCLC Independent of Genomic Alterations

Presenter: Anna Manasherov, MSN-FNP, MPH, Director, Scientific Affairs, OncoHost
Presentation Time: Sunday, November 2, 10:45–11:45, Tuesday, November 3, 9:00-10:00

The second study evaluated the performance of PROphetNSCLC, OncoHost’s commercially available liquid biopsy proteomics test, in predicting immunotherapy benefit across major genomic subgroups.

Analyzing pre-treatment plasma samples from 308 NSCLC patients treated with immune checkpoint inhibitors, the study revealed that a PROphet-POSITIVE result predicted significantly longer overall survival (HR=0.39, p<0.0001) – a benefit consistently observed across KRAS, STK11, TP53, and KEAP1 mutation subgroups.

Importantly, the predictive power of PROphetNSCLC was maintained independent of mutational status and PD-L1 expression, establishing it as a universal biomarker for immunotherapy benefit prediction.

"The data reinforce the value of PROphetNSCLC as an independent, mutation-agnostic tool supporting oncologists in selecting optimal first-line treatments," said Ofer Sharon, MD, CEO at OncoHost. "Our findings highlight the power of proteomics to transcend genomic boundaries and provide actionable clinical insights."

(Press release, OncoHost, NOV 2, 2025, View Source [SID1234659228])

Newly Established Samsung Epis Holdings to Drive Growth for Samsung Bioepis and a New Subsidiary

On November 2, 2025 Samsung Epis Holdings Co., Ltd. reported its establishment as a new investment holding company, following the spin-off of Samsung Bioepis Co., Ltd. from Samsung Biologics (KRX: 207940.KS). Samsung Epis Holdings will be listed on Korea Exchange (KRX) on November 24, 2025, after establishment of a new subsidiary company on November 14, 2025. Samsung Bioepis will continue to operate its biosimilar business as a 100% owned subsidiary of Samsung Epis Holdings.

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Kyung-Ah Kim will serve as the President and Chief Executive Officer (CEO) of Samsung Epis Holdings, in addition to her current role as the President and CEO of Samsung Bioepis. "The new investment holding company will focus on discovering and securing investment opportunities in biotechnology for the company and its subsidiaries’ long-term growth, with scientific innovation remaining the source of our value creation. In the meantime, Samsung Bioepis will remain committed to ensuring the continued development, manufacturing, and distribution of quality-assured biosimilar medicines to patients around the world," said Kyung-Ah Kim, President and CEO of Samsung Epis Holdings. "By establishing an independent decision-making structure, we see the potential for further growth and investment. Progress is being made to secure next-generation therapeutic technology on the back of the capabilities accumulated through our biosimilar business. With the spin-off, we expect to have more opportunities to explore next-generation growth drivers."

(Press release, Samsung Epis Holdings, NOV 2, 2025, View Source [SID1234659229])