2025 was a turning point with key regulatory milestones providing a solid foundation for 2026. Cash runway is projected to extend through December 2026. Preparation of the Phase III RECOVER study is ongoing, including financing related to the trial. Note: See paragraph on Estimated Full-Year 2025 Consolidated Financial Results at the end of this Press … [Read more…]
FDA Approves Initiation of GOLDEN GATE Pivotal Trial Following FDA Breakthrough Device Designation SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Long Bridge Medical, Inc. today announced that the U.S. Food and Drug Administration (FDA) has cleared initiation of its Investigational Device Exemption (IDE) study for LensOne™, the company’s prosthetic capsular bag designed to enable reliable secondary intraocular lens … [Read more…]
FDA Approves Initiation GOLDEN GATE Pivotal Trial Following FDA Breakthrough Device Designation SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Long Bridge Medical, Inc. today announced that the U.S. Food and Drug Administration (FDA) has cleared initiation of its Investigational Device Exemption (IDE) study for LensOne™, the company’s prosthetic capsular bag designed to enable reliable secondary intraocular lens (IOL) … [Read more…]
Webcast on Tuesday, March 31, 2026, at 4:30 p.m. ET LEXINGTON, Mass.–(BUSINESS WIRE)–$AGEN #BAL—Agenus Inc. (“Agenus”) (Nasdaq: AGEN), a leader in immuno-oncology, today announced it will host its March Stakeholder Webcast focused on continued progress of its botensilimab and balstilimab (BOT+BAL) immunotherapy program and will provide an update on the Company’s patient access programs, development … [Read more…]
PALM BEACH GARDENS, Fla.–(BUSINESS WIRE)–Chronilogix, an AI digital health company transforming access, delivery, and cost of chronic care coaching, today announced that Dr. Geoffrey Williams has joined its Advisory Committee. Dr. Williams’ appointment coincides with Chronilogix’s expansion to include a dedicated AI-powered mental health module, further strengthening the company’s mission to deliver affordable, always-available coaching … [Read more…]
While not reaching statistical significance, there was a slowing of disease progression relative to placebo, as measured by IBMFRS, in the overall patient population at the lower dose of ulviprubart, with a 50% slowing of disease progression relative to placebo across both doses in a pre-specified subgroup of patients with less severe disease Ulviprubart demonstrated … [Read more…]
Co-development initiatives to advance next-generation workflows, accelerate adoption, and expand the role of AI within model-informed drug development RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)–Simulations Plus, Inc. (Nasdaq: SLP) (“Simulations Plus” or the “Company”), a global leader in model-informed and AI-accelerated drug development that advances biopharma innovation, today announced strategic collaboration programs with three large pharmaceutical companies … [Read more…]
Lacutamab TELLOMAK-3 confirmatory Phase 3 trial in cutaneous T-cell lymphoma (CTCL) is planned for initiation in H2 2026, subject to non-dilutive financing options currently under negotiation, including pharma partnering and royalty structures IPH4502 (Nectin-4 ADC) shows preliminary anti-tumor activity with favorable safety profile to date; Phase 1 cohort enrichment ongoing at active dose levels Monalizumab … [Read more…]
IdentiClone® Dx IGH is the first IVDR-certified assay for the detection of clonal immunoglobulin gene rearrangements in patients with suspected B-cell lymphoproliferative disease. SAN DIEGO–(BUSINESS WIRE)–Invivoscribe, a global leader in precision diagnostics and measurable residual disease (MRD) testing, is proud to announce that its IdentiClone Dx IGH Assay has received In Vitro Diagnostic Regulation (IVDR) … [Read more…]
BostonGene highlights how its foundation models enable decision-making across drug development and clinical care, with growing adoption by leading biopharma partners WALTHAM, Mass.–(BUSINESS WIRE)–BostonGene, developer of the leading AI foundation model for tumor and immune biology, today announced its participation at the 23rd Annual Meeting of the Japanese Society of Medical Oncology (JSMO2026) from March … [Read more…]
