Core Insights - Genmab A/S has released results from the Phase 3 EPCORE FL-1 trial, showing that subcutaneous epcoritamab in combination with rituximab and lenalidomide (R2) significantly improves outcomes for adult patients with relapsed or refractory follicular lymphoma [1][2] Study Results - The trial met its dual primary endpoints of overall response rate (ORR) and progression-free survival (PFS), demonstrating a 79% reduction in the risk of disease progression or death [2] - Results will be presented at the 67th Annual Meeting and Exposition of the American Society of Hematology (ASH) and will support global regulatory submissions [3] Regulatory Developments - The U.S. FDA has accepted for priority review the supplemental Biologics License Application (sBLA) for epcoritamab plus R2, based on significant ORR and PFS improvements from interim analysis [4] - The FDA has set a target action date of November 30, 2025, for the sBLA [5] Market Performance - Genmab reported revenue of $1.64 billion for the first half of 2025, up from $1.38 billion year-over-year, with second-quarter sales of $925 million exceeding consensus estimates [6] - The 19% revenue increase was driven by higher royalties from collaborations and increased sales of Epkinly [7] - The company raised its fiscal year 2025 sales guidance to between $3.5 billion and $3.7 billion, surpassing consensus expectations [7]

Core Insights - Genmab A/S announced positive results from the Phase 3 EPCORE FL-1 trial for subcutaneous epcoritamab in combination with rituximab and lenalidomide, showing significant improvements in overall response rate (ORR) and progression-free survival (PFS) for patients with relapsed or refractory follicular lymphoma [2][6][4] - The U.S. FDA has accepted the supplemental Biologics License Application (sBLA) for epcoritamab plus rituximab, with a target action date of November 30, 2025, which could make it the first bispecific antibody combination available in the U.S. for second-line treatment of this condition [3][6] - Epcoritamab is designed to target CD3 on T cells and CD20 on B cells, facilitating T-cell-mediated killing of malignant B cells, and has received regulatory approval in various lymphoma indications [8][9] Trial Results - The EPCORE FL-1 trial met its dual primary endpoints, achieving an ORR of 95.7% (p-value < 0.0001) and a PFS hazard ratio of 0.21 (p-value < 0.0001), indicating a 79% reduction in the risk of disease progression or death [2][6][4] - The safety profile of epcoritamab in combination with rituximab was consistent with known safety profiles, with no new safety signals observed [4][6] Industry Context - Follicular lymphoma (FL) is a slow-growing form of non-Hodgkin's lymphoma, accounting for 20-30% of all NHL cases, with approximately 15,000 new cases annually in the U.S. [5] - Current treatment options for R/R FL often lead to declining response rates and shorter remission periods, with over 25% of patients potentially transforming to aggressive large-cell lymphoma [5][4] Company Overview - Genmab is an international biotechnology company focused on developing innovative antibody therapeutics, with a vision to transform cancer treatment by 2030 [11][12] - The company is co-developing epcoritamab with AbbVie, sharing commercial responsibilities in the U.S. and Japan, while pursuing additional international regulatory approvals [9][10]

Core Insights - Knight Therapeutics Inc. has launched Minjuvi® (tafasitamab) in Mexico through its affiliate Grupo Biotoscana de Especialidad S.A. de C.V. [1] - Minjuvi® is indicated for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplantation (ASCT) [2][4]. Company Overview - Knight Therapeutics Inc. is a pan-American specialty pharmaceutical company focused on acquiring and commercializing pharmaceutical products in Canada and Latin America [12]. - The company entered a supply and distribution agreement with Incyte for exclusive rights to distribute tafasitamab in Latin America [7]. Product Details - Minjuvi® is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody, demonstrating a 60% objective response rate (ORR) in clinical trials [4][8]. - The L-MIND trial showed a complete response rate (CR) of 43% and a disease control rate (DCR) of 74% for Minjuvi® in combination with lenalidomide [4]. Clinical Significance - DLBCL is the most common subtype of non-Hodgkin lymphoma, with many patients facing poor prognosis due to refractory disease or relapse [3]. - Approximately 57% of patients responding to Minjuvi® remained in remission at 5 years, highlighting its effectiveness as a treatment option [5]. Regulatory Approval - Minjuvi® received marketing authorization in Mexico based on the L-MIND trial data and was recognized as an orphan medicine by COFEPRIS [4][7]. - The product has also received accelerated approval in the United States and conditional marketing authorization in Europe for similar indications [9].

Viatris (VTRS) Q4 2024 Earnings Call February 27, 2025 06:24 PM ET Company Participants Bill Szablewski - Head of Investor Relations & Capital MarketsScott Smith - CEOPhilippe Martin - Chief R&D OfficerCorinne Le Goff - Chief Commercial OfficerDoretta Mistras - CFOAshwani Verma - Executive Director - SMID Biotech & BiopharmaChris Schott - Managing DirectorJason Gerberry - MD & Equity ResearchUmer Raffat - Senior Managing Director Conference Call Participants David Amsellem - Sr. Research AnalystBalaji Prasa ...