Core Insights - INmune Bio is a clinical stage biotechnology company focused on developing therapies for neuroinflammation in neurodegenerative diseases, with its lead program XPro1595 being a first-in-class selective soluble TNF inhibitor [1] Group 1: Clinical Development - The objective of the recent webinar was to demonstrate how the clinical results from the Phase II MINDFuL trial will inform the registration program for XPro1595 [2] - A productive end of Phase II meeting with the FDA confirmed alignment on the core elements of the Phase III registration program [2] Group 2: Trial Design and Outcomes - The MINDFuL trial was a strategic proof-of-concept study designed to address two critical variables: biologic signal and patient selection in Alzheimer's disease [3] - The trial aimed to determine if XPro1595 shows biologic activity in patients with Alzheimer's disease and inflammation biomarkers, and whether the right patient population for a registration trial could be identified [3] - Results indicated that XPro1595 demonstrated biologic activity and validated a precision medicine roadmap for the Phase III registration program [3]

Summary of Sagimet Biosciences FY Conference Call Company Overview - **Company**: Sagimet Biosciences (NasdaqGM:SGMT) - **Focus**: Clinical-stage biopharmaceutical company targeting fatty acid synthase (FASN) overactivity in conditions like MASH (metabolic dysfunction-associated steatotic liver disease), acne, and certain solid tumors [3][4] Key Points on MASH - **Lead Program**: Denifanstat, a FASN inhibitor, targets fat accumulation, inflammation, and fibrosis, which are primary drivers of MASH [3][4] - **Phase II Study Results**: - Successful completion of Phase II study with significant reductions in inflammation and fibrosis, particularly in severe patients [5][11] - 13 patients diagnosed as qF4 showed 11 had a 1- or 2-stage improvement in fibrosis [6][13] - Denifanstat is the only drug that directly addresses fat, inflammation, and fibrosis [10][11] - **Combination Therapy**: - Plans to combine denifanstat with resmetirom for enhanced efficacy in treating MASH [15][16] - Preclinical data suggests synergistic effects of the combination [16][17] - **Regulatory Pathway**: Anticipation of starting Phase II study in the second half of the year, with a focus on non-invasive tests as potential endpoints [24][25] Key Points on Acne - **Acne Studies**: Partner Ascletis conducted Phase III studies in China showing statistically significant efficacy and safety for denifanstat in moderate to severe acne [40][41] - **Approval Timeline**: NDA accepted by NMPA in December 2025, with potential approval within 12 months [42] - **Market Potential**: - 50 million Americans suffer from acne, with 10 million classified as moderate to severe [48] - Novel mechanism of action expected to expand the patient population seeking treatment [48][49] Financial and Strategic Insights - **Milestone Payments**: Sagimet eligible for up to $122 million in milestone payments and tiered royalties from sales in Greater China [42] - **Valuation Perspective**: Company viewed as undervalued with significant progress expected in both MASH and acne indications [50] Additional Insights - **Patient-Centric Approach**: Emphasis on developing a combination therapy that is patient-friendly, with a single oral tablet versus injectables [31][32] - **Precision Medicine**: Pursuing a precision medicine approach for MASH, focusing on biomarkers to identify patients likely to respond to treatment [37] - **Competitive Landscape**: Anticipation of DENNY plus resmetirom becoming frontline therapy upon approval, with a welcoming stance towards GLP-1 treatments as they may help diagnose more patients [28][29] This summary encapsulates the critical insights from the conference call, highlighting Sagimet Biosciences' strategic direction, clinical advancements, and market potential in both MASH and acne treatments.

are based upon current expectations and assumptions that involve risks, changes in circumstances and uncertainties. Important factors that could cause actual results to differ materially from those reflected in Vanda's forward-looking statements include, among others, the FDA's ability to complete its review of, and reach a decision with respect to, the imsidolimab BLA by December 12, 2026; Vanda's assumptions regarding how imsidolimab achieves its therapeutic effect; Vanda's ability to obtain FDA approval ...

Highlights Fourth quarter 2025 revenue of $209.8 million was consistent with fourth quarter 2024 revenue, but grew 4% year-over-year when excluding the previously discussed headwind1 of $8.1 million.Full year 2025 revenue of $824.5 million decreased 2% year-over-year. Excluding headwinds2, full year 2025 revenue grew 2% year-over-year. Drivers of fourth quarter 2025 test volume growth year-over-year include Prolaris prostate cancer test at 12%, Hereditary cancer testing at 9%, and GeneSight at 9%. Fourth qu ...

NEW YORK, Feb. 23, 2026 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company focused on developing innovative treatments for Alzheimer's disease, Parkinson's disease, schizophrenia, neurodevelopmental, neurodegenerative, and rare diseases, including Rett syndrome, and other central nervous system (CNS) disorders, today announced the appointment of Dr. Axel Paeger, MD, MBA, MBI to its Board of Directors. “We are delighted to wel ...

BOSTON, Feb. 18, 2026 (GLOBE NEWSWIRE) -- Tango Therapeutics, Inc. (NASDAQ: TNGX), today announced that it will report fourth quarter 2025 financial results on March 5, 2026, before the open of the U.S. financial markets. The company does not intend to hold a conference call. Additionally, Tango Therapeutics management is scheduled to participate in three upcoming investor conferences: TD Cowen 46th Annual Health Care Conference, Boston Corporate presentation on Wednesday, March 4 at 1:10-1:40 PM ETWebcast ...

Ms. Kazem brings extensive and global expertise in corporate governance and securities law, drawing on a distinguished track record as external legal counsel to leading life sciences companiesChief Legal Officer (CLO) appointment enhances leadership capabilities to advance three highly differentiated late-stage assets toward near-term clinical and regulatory milestones ZUG, Switzerland, February 17, 2026 -- Oculis Holding AG (Nasdaq: OCS / XICE: OCS) (“Oculis”), a global biopharmaceutical company focused on ...

Core Viewpoint - CareDx is focusing on advancing AI-enabled relapse monitoring for Acute Myeloid Leukemia (AML) and Myelodysplastic Syndromes (MDS) post-cell therapy, positioning itself as a leader in precision medicine for cell therapy [1]. Group 1: Company Overview - CareDx is conducting an investor webinar to discuss its initiatives and advancements in precision medicine [1]. - The company aims to enhance its competitive position and explore potential growth opportunities within the industry [2]. Group 2: Future Outlook - CareDx's future business plans include the development of testing services and digital solutions aimed at increasing revenue and commercial success [2]. - The company is engaged in clinical trial collaborations and registry studies to support its growth and market opportunities [2].

Core Insights - The FDA has provided regulatory clarity on INmune Bio's integrated Phase 2b/3 clinical development strategy for XPro1595 in early Alzheimer's Disease, confirming CDR-SB as the sole primary endpoint for registrational development [1][2][5] FDA Alignment Highlights - The FDA's feedback validates the enrichment-led design and primary endpoint, supporting the scientific and clinical strategy of the company [2][5] - The Phase 2b study will include approximately 300 participants over a nine-month evaluation period, utilizing the Early Mild Alzheimer's Cognitive Composite (EMACC) and plasma p-tau-217 as key measures [4][5] - CDR-SB will serve as the sole primary efficacy endpoint for the Phase 3 segment, aligning with its established role in Alzheimer's therapies [5][6] Integrated Phase 2b/3 Framework - The FDA indicated no objection to the integrated Phase 2b/3 design under a single master protocol, with the full program expected to enroll around 1,000 participants [5] - The Phase 3 portion will evaluate XPro1595 over an 18-month period [5] - An exploratory cohort of non-enriched early Alzheimer's patients will be included to assess broader effects, comprising approximately 20% of total enrollment [5] XPro™ Overview - XPro™ is a next-generation TNF inhibitor that selectively neutralizes soluble TNF, potentially reducing neuroinflammation and improving cognitive function in neurological diseases [8] Company Background - INmune Bio Inc. is a late-stage clinical biotechnology company focused on developing treatments targeting the innate immune system, with three product platforms including XPro™ [9]

Core Viewpoint - VolitionRx Limited is sponsoring a symposium at the European Hidradenitis Suppurativa Foundation Conference to present findings on the Nu.Q NETs assay, which aids in the management of Hidradenitis Suppurativa (HS) through a precision medicine approach [1][2][3]. Company Overview - VolitionRx Limited is a multi-national epigenetics company focused on advancing the science of epigenetics and improving outcomes for patients through earlier detection and monitoring of diseases [11][12]. - The company is developing cost-effective blood tests for various diseases, including cancers and conditions associated with NETosis, aiming to enhance patient quality of life [12]. Industry Context - Hidradenitis Suppurativa (HS) is a chronic condition affecting approximately 1% of the global population, characterized by painful skin abscesses and scarring [3][9]. - The condition is difficult to manage, and the introduction of biological treatments has shown varied responses among patients, highlighting the need for a precision medicine approach [4][9]. Product and Market Potential - The Nu.Q NETs assay is CE-Marked for clinical use in 27 EU member states and is positioned as a simple, low-cost test to detect diseases associated with NETosis, with a total addressable market estimated at $3.8 billion [6][8]. - The assay aims to classify HS patients and guide treatment decisions, potentially improving patient management and outcomes [4][6].