Danaher Corporation Fourth Quarter 2025 Earnings Release January 28, 2026 Forward Looking Statements Statements in this presentation that are not strictly historical, including any statements regarding events or developments that we believe or anticipate will or may occur in the future are "forward- looking" statements within the meaning of the federal securities laws. There are a number of important factors that could cause actual results, developments and business decisions to differ materially from those ...

Hardman Johnston Global Advisors, an investment management company, released its “Hardman Johnston Global Equity Strategy” investor letter for the fourth quarter of 2025. A copy of the letter can be downloaded here. Global equity markets delivered robust results in the quarter, backed by easing inflation trends and strong economic data. The Hardman Johnston Global Equity Strategy returned 2.91%, net of fees, compared to the MSCI AC World Net Index’s 3.29% gain. The Financials and Consumer Staples sectors c ...

Core Viewpoint - REGENXBIO Inc. has announced that the FDA has placed a clinical hold on its investigational gene therapies RGX-111 and RGX-121 due to a case of neoplasm identified in a participant treated with RGX-111, raising concerns about the safety of both therapies [1][2]. Group 1: Clinical Hold Details - The FDA's clinical hold on RGX-111 and RGX-121 is based on a single case of an intraventricular CNS tumor found in a five-year-old participant who received RGX-111 four years prior [1][2]. - Preliminary genetic analysis of the tumor indicated an AAV vector genome integration event linked to overexpression of the proto-oncogene PLAG1, which is associated with chromosomal rearrangements [2]. Group 2: Company Response - REGENXBIO expressed surprise at the FDA's decision to place RGX-121 on hold, emphasizing that RGX-121 has a positive safety profile based on data from over 30 patients treated [3]. - The company highlighted the urgent medical need for RGX-121 in treating MPS II, stating that delays could lead to neurodevelopmental decline in affected patients [3]. Group 3: Therapy Information - RGX-121 is a one-time gene therapy designed to deliver the iduronate-2-sulfatase (IDS) gene to the CNS, potentially providing a permanent source of the I2S protein beyond the blood-brain barrier [4]. - RGX-111 aims to deliver the alpha-L-iduronidase (IDUA) gene to the CNS, which could help prevent cognitive deficits in MPS I patients [7]. Group 4: Disease Background - MPS II, or Hunter Syndrome, is a rare disease caused by a deficiency in the lysosomal enzyme I2S, leading to the accumulation of glycosaminoglycans and resulting in dysfunction across various tissues, including the CNS [6]. - MPS I is a rare genetic disease caused by a deficiency in the enzyme IDUA, leading to similar accumulations and dysfunctions, with an estimated occurrence of 1 in 100,000 births [9].

Core Insights - The FDA has granted Breakthrough Therapy Designation to Biogen's litifilimab (BIIB059) for treating cutaneous lupus erythematosus (CLE), recognizing the urgent need for new therapies in this area [1][2][3] Company Overview - Biogen is a leading biotechnology company founded in 1978, focused on pioneering innovative science to deliver new medicines and create value for shareholders [10] - The company is advancing litifilimab as a first-in-class therapy targeting blood dendritic cell antigen 2 (BDCA2) for CLE, with ongoing clinical trials [3][5] Product Information - Litifilimab is a humanized IgG1 monoclonal antibody targeting BDCA2, currently under investigation for systemic lupus erythematosus (SLE) and CLE [5][6] - The drug has shown promise in reducing skin disease activity in CLE patients, as evidenced by results from the Phase 2 LILAC study [2][6] Clinical Development - The FDA's designation aims to expedite the development and review process for litifilimab, which is currently being evaluated in the AMETHYST Phase 3 study, with data readout expected in 2027 [3][6] - The current standard of care for CLE includes topical steroids, antimalarials, and immunosuppressants, but these do not alter disease progression [2][6] Industry Context - CLE is a chronic autoimmune skin disease that significantly impacts patients' quality of life, with symptoms including rash, pain, and potential irreversible skin damage [8][9] - The Lupus Research Alliance emphasizes the need for effective therapies that can alter the disease course, highlighting the importance of incorporating patient voices in drug development [4]

Core Insights - Vera Therapeutics has appointed Matt Skelton as Chief Commercial Officer to lead the commercial launch of atacicept for IgA nephropathy [1][2] - Atacicept is a promising investigational treatment that targets B-cell activation and has shown significant clinical efficacy in trials [3][4][6] Company Overview - Vera Therapeutics is a late clinical-stage biotechnology company focused on developing treatments for serious immunological diseases [10] - The company's lead product candidate, atacicept, is designed to block B-cell Activating Factor (BAFF) and A PRoliferation-Inducing Ligand (APRIL), which are involved in autoimmune diseases [10] Leadership Appointment - Matt Skelton brings extensive experience in global commercialization, having previously scaled Seagen's commercial organization from one product to four approved products [2][10] - His leadership is expected to be critical in transitioning Vera Therapeutics into a commercial-stage company [2] Atacicept Clinical Program - The ORIGIN Phase 2b clinical trial of atacicept met its primary and key secondary endpoints, showing significant reductions in proteinuria and stabilization of eGFR [4] - The ongoing ORIGIN 3 Phase 3 trial has also met its primary endpoint with a statistically significant reduction in proteinuria at week 36 [5] Regulatory Status - Atacicept has received Breakthrough Therapy Designation from the FDA for IgA nephropathy, indicating its potential to significantly improve treatment outcomes [6] - The Biologics License Application (BLA) for atacicept has received Priority Review designation, with a target action date set for July 7, 2026 [7] Future Studies - The ORIGIN Extend study allows participants to access atacicept until its commercial availability and collects long-term safety and efficacy data [8] - Atacicept is also being evaluated in other autoimmune kidney diseases, expanding its potential therapeutic applications [8][10]

Core Insights - BriaCell Therapeutics Corp. has released new imaging data demonstrating the resolution of metastatic breast cancer lesions in patients with various organ involvements, highlighting the effectiveness of their immunotherapy treatment [1][6]. Patient Outcomes - Patient 11-018, a 66-year-old woman with ER+/PR+/HER2+ metastatic breast cancer, achieved 27 months of survival post-enrollment after 35 cycles of Bria-IMT treatment, showing complete resolution of temporal lobe metastasis and significant improvement in orbital lesions [2][4]. - Patient 15-005, a 44-year-old woman with ER+/PR+/HER2- metastatic breast cancer, remains in stable condition 27 months after treatment, having completed 6 cycles of therapy [9]. - Patient 15-006, a 64-year-old woman with ER+/PR-/HER2- metastatic breast cancer, has survived 25 months post-enrollment after receiving 4 cycles of Bria-IMT treatment [13]. Mechanism of Action - The CD8 ImmunoPET imaging confirms that BriaCell's treatment activates CD8+ cytotoxic T cells, which infiltrate tumors, potentially enhancing long-term patient survival even after treatment cessation [3]. Study Details - The Phase 2 study involved 54 heavily pre-treated metastatic breast cancer patients, with a median of six prior therapies, who received the Bria-IMT regimen alongside a checkpoint inhibitor. Notably, no treatment-related discontinuations have been reported [17].

Images below confirm clinical responses seen in patients with metastatic orbital (eye), temporal (brain), liver, and spine lesions No Bria-IMT™ related discontinuations reported to dateBria-IMT regimen continues under Fast Track Designation from US FDA PHILADELPHIA and VANCOUVER, British Columbia, Jan. 28, 2026 (GLOBE NEWSWIRE) -- BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW, BCTXZ, BCTXL) (TSX: BCT) (“BriaCell” or the “Company”), a clinical-stage biotechnology company developing novel immunotherapies t ...

Core Insights - Samsung Biologics has achieved the EcoVadis Platinum Sustainability Rating, the highest recognition for corporate sustainability performance, placing it in the top one percent of evaluated companies globally [1][2][10] Sustainability Performance - The EcoVadis rating evaluates corporate social responsibility across four areas: Environment, Labor & Human Rights, Ethics, and Sustainable Procurement [2] - Samsung Biologics was previously awarded the Gold Sustainability Rating in 2024, indicating a consistent improvement in sustainability practices [3] Management Commitment - John Rim, President and CEO, emphasized the company's commitment to responsible business practices and long-term partnerships that contribute to a sustainable healthcare ecosystem [4] - The company has enhanced sustainability initiatives, including increased use of renewable energy and improved ethical compliance frameworks [4] Industry Engagement - Samsung Biologics received an 'A' rating in Water Security from the Carbon Disclosure Project (CDP) in December 2025 [4] - As a Champion of the Sustainable Markets Initiative Health Systems Task Force, the company engages global suppliers in decarbonization efforts [4] Manufacturing Capacity - Samsung Biologics has a combined biomanufacturing capacity of 785,000 liters, with an additional 60,000 liters expected from a facility acquisition in Rockville, Maryland, by the end of Q1 2026 [7] - The company utilizes advanced technologies for various biopharmaceutical modalities, including multispecific antibodies and mRNA therapeutics [7] Operational Excellence - The ExellenSâ"¢ framework is implemented across the manufacturing network to ensure standardized designs and processes, enhancing manufacturing continuity [8] - The global manufacturing network includes operations in Korea, the U.S., and Japan, with a focus on delivering high-quality biomedicines [9]

SAN JOSE, Calif., Jan. 28, 2026 (GLOBE NEWSWIRE) -- Rani Therapeutics Holdings, Inc. (“Rani Therapeutics” or “Rani”) (Nasdaq: RANI), a clinical-stage biotherapeutics company focused on the oral delivery of biologics and drugs, today announced the promotion of Alireza Javadi, Ph.D., to Chief Technical Officer. “We are thrilled to announce Alireza’s promotion to Chief Technical Officer as we enter an exciting era for Rani, highlighted by our collaboration with Chugai and our newly initiated Phase 1 study of R ...

BioMarin Pharmaceutical (NASDAQ:BMRN) is one of the best large cap stocks under $100 with huge upside potential. On January 20, Canaccord Genuity analyst Whitney Ijem revised her Hold rating on BioMarin Pharmaceutical (NASDAQ:BMRN) to Buy. She also raised her price target estimate from $84 to $98, offering an upside of almost 75% from the prevailing level. Illumina (ILMN) Jumps 24.8% on Earnings Beat RAJ CREATIONZS / shutterstock.com Ijem’s upward revisions are based on the company’s encouraging fundam ...