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  • TissueCypher® Impacts Barrett’s Esophagus Management: Actionable Risk Insights Presented at ACG

    Castle Biosciences’ TissueCypher Barrett’s Esophagus test demonstrates risk insights beyond pathology, influencing clinical management, according to new data presented at ACG 2025. Research by Horvath et al. on TissueCypher received a Presidential Poster Award. Case studies showed TissueCypher identified patients at high risk for progression to esophageal cancer, prompting earlier interventions. In a rural study, the test influenced clinical management in 93% of cases, safely extending surveillance intervals for low-risk patients while ensuring timely intervention for higher-risk individuals.

    2025年11月5日
  • Avidity Biosciences to be Acquired by Novartis

    Novartis intends to acquire Avidity Biosciences for $12 billion, a 46% premium, focusing on Avidity’s neuroscience pipeline and Antibody Oligonucleotide Conjugates (AOCs™) platform enabling targeted RNA delivery. The deal hinges on spinning off Avidity’s cardiology programs into “SpinCo,” capitalized with $270 million. Novartis gains access to late-stage clinical programs for Duchenne muscular dystrophy, myotonic dystrophy, and facioscapulohumeral muscular dystrophy, aligning with its neuroscience portfolio. SpinCo will advance cardiology-focused AOC programs and existing collaborations. The acquisition awaits regulatory approval.

    2025年11月5日
  • Fate Therapeutics Presents FT819 CAR T-Cell Data Demonstrating Immune Remodeling and Durable Responses in Systemic Lupus Erythematosus Patients at ACR Convergence 2025

    Fate Therapeutics reported positive Phase 1 data for FT819, an off-the-shelf CAR T-cell therapy, in ten treatment-refractory SLE patients. A single dose resulted in rapid B-cell depletion and immune remodeling. The study showed durable clinical responses, including complete renal responses and steroid-free remission. FT819 demonstrated a favorable safety profile with low-grade CRS and no ICANS or GvHD. The data support potential outpatient administration and a pivotal study in 2026. These results suggest FT819’s transformative potential for SLE treatment.

    2025年11月5日
  • Village Farms International Announces Q3 2025 Earnings Release Date: November 10, 2025

    Village Farms International (VFF) will release its third quarter 2025 financial results on Monday, November 10, 2025, at 7:00 a.m. ET. A conference call and webcast will follow at 8:30 a.m. ET that day, focusing on the results and featuring a Q&A session. The company’s diversification strategy, including cannabis operations and renewable natural gas production, will likely be discussed. A replay of the call will be available on the investor relations website. Advance registration is required for telephone participation.

    2025年11月4日
  • HD Hyundai Heavy Industries & HII to Partner on Distributed Shipbuilding and Auxiliary/Commercial Vessels

    On October 26, 2025, Huntington Ingalls Industries (HII) and HD Hyundai Heavy Industries (HHI) signed a memorandum of agreement (MOA) to enhance U.S.-Korea shipbuilding cooperation. The agreement focuses on distributed shipbuilding, Navy auxiliary programs, AI/ML and automation R&D, and in-theater ship lifecycle support. The companies will jointly pursue the U.S. Navy’s next-generation logistics ship (NGLS) design contract. This partnership aims to leverage HHI’s commercial shipbuilding expertise and HII’s experience with U.S. Navy contracts, bolstering the U.S. shipbuilding industrial base.

    2025年11月4日
  • Incyte Presents Phase 3b TRuE-AD4 Trial Results of Opzelura® (Ruxolitinib Cream) for Moderate Atopic Dermatitis in Adults

    Incyte’s Phase 3b TRuE-AD4 trial results, presented at ISAD, demonstrate Opzelura’s effectiveness and safety in adult patients with moderate atopic dermatitis (AD) who had inadequate responses to topical corticosteroids or calcineurin inhibitors. Opzelura significantly improved AD clinical signs, with 70% achieving EASI75 and 61.3% achieving IGA-TS at Week 8. Patients experienced rapid itch reduction and improved quality of life. Incyte plans to file for EU approval based on these data, aiming to provide a non-steroidal alternative for AD treatment.

    2025年11月4日
  • Visionary Holdings Inc. Notified by Nasdaq on Late Form 20-F Filing

    Visionary Holdings Inc. received a Nasdaq notification on August 5, 2025, for non-compliance with Listing Rule 5250(c)(1) due to a delayed Form 20-F filing. Visionary submitted a compliance plan on October 6, 2025, and is working with its auditor to expedite the filing. The company is committed to Nasdaq listing. Analysts note that reporting delays can raise investor concerns, while Visionary’s tech-focused model may contribute to audit complexities. The company must address the delay to maintain investor confidence and avoid potential delisting.

    2025年11月4日
  • BBO-10203, a Novel RAS:PI3Kα Inhibitor, Demonstrates Promising Preclinical Efficacy in KRAS-Mutant Tumors without Hyperglycemia: Data Presented at AACR-NCI-EORTC 2025

    BridgeBio Oncology Therapeutics announced positive preclinical data for BBO-10203, a novel compound selectively disrupting the RAS:PI3Kα interaction crucial for KRAS-mutant tumor growth. BBO-10203 inhibits RAS-driven PI3Kα-AKT signaling without causing hyperglycemia. In vivo studies showed oral bioavailability and significant anti-tumor activity, with deep tumor regressions when combined with BridgeBio’s KRAS inhibitors. BBO-10203 is currently in Phase 1 trial (BREAKER-101), and initial Phase 1 clinical data is expected in H1 2026.

    2025年11月3日
  • Cullinan Therapeutics Presents Preclinical Data on CLN-978 B Cell Depletion at ACR Convergence 2025, Supporting Clinical Development in Autoimmune Diseases

    Cullinan Therapeutics will present preclinical data on CLN-978, a CD19xCD3 bispecific T cell engager, at ACR Convergence 2025. Studies show CLN-978 rapidly depleted B cells in samples from RA, Sjögren’s, and SLE patients, and in nonhuman primates after subcutaneous dosing. In a SLE mouse model, it reduced B cells, anti-dsDNA IgG, and kidney IgG deposition. Cullinan is advancing CLN-978 in OUTRACE clinical programs for RA, SjD, and SLE.

    2025年11月3日
  • Phathom: VOQUEZNA® (vonoprazan) Demonstrates Nocturnal GERD Symptom Improvement in NERD Patients

    Phathom Pharmaceuticals’ VOQUEZNA (vonoprazan) demonstrated rapid and sustained relief of nocturnal GERD symptoms in a Phase 3 trial. Patients experienced significantly more heartburn-free nights compared to placebo, with symptom relief starting after the first dose and lasting through a 20-week extension. VOQUEZNA was generally well-tolerated, though the label includes postmarketing risks requiring monitoring. Some efficacy analyses were exploratory and not adjusted for multiple comparisons. VOQUEZNA is approved in the US for GERD and *H. pylori* treatment.

    2025年11月3日