Core Insights - Fractyl Health, Inc. has appointed Lara Smith Weber as Chief Financial Officer, effective January 12, 2026, to oversee finance, accounting, and investor relations, and to support the executive leadership team and Board of Directors [1][3] Company Overview - Fractyl Health is a metabolic therapeutics company focused on innovative treatments for obesity and type 2 diabetes (T2D), aiming to shift from chronic management to durable disease-modifying therapies [5] - The company has a strong intellectual property portfolio, with 35 granted U.S. patents and approximately 45 pending U.S. applications, alongside numerous foreign patents [5] Leadership Transition - Lara Smith Weber brings over 20 years of financial leadership experience in medtech and biotech, with a proven track record in building financial organizations and guiding companies through operational scaling [2][3] - Ms. Smith Weber's previous roles include CFO at Inari and ONWARD Medical, where she strengthened capital structures and financial systems [3] - Lisa Davidson, the former CFO, resigned effective December 31, 2025, after ten years with the company, during which she played a key role in its growth and IPO [4][5]

Core Insights - Tango Therapeutics, Inc. has appointed Mr. Sung Lee to its Board of Directors, bringing over 20 years of finance leadership experience in the biopharmaceutical and technology sectors [1][2] Company Overview - Tango Therapeutics is a clinical-stage biotechnology company focused on developing precision cancer medicines [1] - The company is advancing its lead program, vopimetostat, into registrational studies [2] Leadership Appointment - Mr. Sung Lee's experience includes serving as Executive Vice President and Chief Financial Officer at Cytokinetics since May 2024, and prior roles at Vir Biotechnology, MorphoSys, and Sangamo Therapeutics [2] - He has a strong background in corporate strategy, investor relations, and finance, which will support Tango's late-stage clinical development activities [2] Educational Background - Mr. Lee holds a bachelor's degree in economics from the University of California, Irvine, and a Master of Business Taxation from the University of Southern California [2]

Summary of Biogen's Conference Call on Felzartamab and Nephrology Developments Company and Industry Overview - **Company**: Biogen - **Industry**: Biopharmaceuticals, specifically focusing on nephrology and autoimmune diseases Key Takeaways from ASN Meeting - The ASN meeting highlighted a significant shift towards innovative therapies in nephrology, emphasizing the potential for cures rather than just managing complications of kidney diseases [3][4] - There is a growing enthusiasm for new therapies that could transform treatment paradigms in nephrology [3] Felzartamab (Felza) Overview - Felzartamab is a targeted therapy developed for severe immune diseases, particularly focusing on conditions like IgA nephropathy and antibody-mediated rejection (AMR) [5][6] - The therapy targets CD38, which is expressed on antibody-producing cells, offering a novel approach in treating autoimmune diseases [9][10] Indications and Clinical Studies - Initial indications for Felza include: - **IgA Nephropathy**: Demonstrated durable treatment effects extending beyond dosing intervals, with significant efficacy observed in early studies [12][14] - **AMR**: A small phase two study showed an 80% resolution rate in microvascular inflammation, indicating transformative efficacy [12][24] - **Primary Membranous Nephropathy (PMN)**: Targeting high-risk patients who are refractory to existing therapies [33] Competitive Landscape and Market Positioning - The treatment landscape for IgA nephropathy is evolving, with multiple therapies expected to enter the market soon, including foundational therapies and targeted therapies [15][16] - Felza is positioned as a disease-modifying therapy that may provide a durable response without the need for continuous dosing, unlike other therapies that require ongoing administration [17][18] Regulatory and Development Strategy - The primary endpoint for the phase three AMR study is the resolution of AMR by histology, with a focus on durability and stabilization of kidney function [29][30] - The anticipated timeline for AMR data is 2027, with a filing expected in 2028, followed by studies for isolated microvascular inflammation and PMN [36][37] Safety and Efficacy Considerations - Long-term safety data is still needed, as current studies have been relatively small and of short duration [18] - The potential for combination therapies and patient preferences will play a crucial role in treatment decisions [18][22] Future Directions and Insights - Ongoing research aims to deepen the understanding of disease mechanisms, particularly the role of NK cells in AMR and the complexities of antibody-mediated diseases [40][41] - Biogen is exploring subcutaneous dosing options for Felza to improve patient access and tolerability [38] Conclusion - Biogen is at the forefront of advancing Felzartamab in nephrology, with promising data and a strategic approach to addressing significant unmet needs in autoimmune kidney diseases [42][43]

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].

Core Insights - Biogen has initiated a phase III study for its candidate felzartamab in adult kidney transplant recipients with late antibody-mediated rejection (AMR), a major cause of transplant failure [1][2] - The study will enroll approximately 120 participants and aims to evaluate the efficacy and safety of felzartamab compared to a placebo, with a primary endpoint focused on AMR resolution by biopsy at 6 months [2] - Felzartamab has received Breakthrough Therapy designation from the FDA for the AMR indication [2] Pipeline Development - Biogen is exploring felzartamab for various immune-mediated diseases, indicating its potential as a "pipeline-in-a-product" [4] - Ongoing phase II studies for felzartamab include indications for primary membranous nephropathy (PMN) and Immunoglobulin A nephropathy (IgAN), with plans to start phase III studies in 2025 [5] - The candidate was acquired through Biogen's purchase of Human Immunology Biosciences in July last year, which included rights to felzartamab globally, excluding China [6] Financial Implications - Following the start of the phase III study, Biogen will make a milestone payment of $35 million to MorphoSys [7] - Biogen's stock has seen a decline of 36.6% over the past year, compared to an 8.5% decline in the industry [3]