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What’s in Today’s Brief? (September 2nd Preview)
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Lilly-Merida autoimmunity M&A
Eli Lilly agreed to acquire Merida Biosciences for up to $2.875 billion, adding a platform aimed at selectively degrading pathogenic autoantibodies rather than broadly suppressing immune function. The deal is expected to close by the end of the year and follows Lilly’s aggressive 2026 acquisition pace. Merida’s lead program, MER511, is an Fc fusion protein being developed in Graves’ disease and thyroid eye disease (TED). Lilly said the approach is designed to neutralize thyroid-stimulating immunoglobulins and drive autoantibody clearance through FcγRIIB-mediated degradation in liver sinusoidal endothelial cells. The company is preparing to advance MER511 after Phase 1 NEXUS (NCT07305818) data planning shared at ENDO2026, with the Phase 1 focus on safety, tolerability, PK/PD and immunogenicity. A second program, MER769, is preclinical for allergic disease, extending Lilly’s precision approach beyond thyroid autoimmunity.
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ARPA-H funding for automated RNA manufacturing
ARPA-H awarded up to $125 million under its GIVE (Genetic Medicines and Individualized Manufacturing for Everyone) program to build a domestic, automated network for producing on-demand RNA-based genetic medicines with quality control at or near the point of care. The effort targets low-cost manufacturing and embedded testing in workflows designed for speed and scalability. Massachusetts General Hospital leads development of a single-use, all-fluidics chip system and control unit for continuous manufacturing plus quality control testing. Centillion Biosciences will focus on end-to-end automated cartridge-based RNA/DNA manufacturing systems and integrated fill-finish and QC, while HDT Bio is set to deliver an architecture platform combining automated DNA synthesis and chip-based RNA production with robotics-enabled lot release testing. A separate team led by Waterfall Scientific will build a fully automated continuous-flow benchtop production system for RNA drug products and an autonomous QC approach. The University of Utah will oversee a same-day genetic medicine testing platform for multi-parameter lot release, all designed to support efficient transition from development to bedside delivery.
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GSK mRNA flu trial move to pivotal study
GSK said it will begin a pivotal Phase 3 trial for its mRNA seasonal influenza vaccine after a Phase 2 study showed higher immune responses than traditional flu vaccines. The move positions the company to compete in mRNA flu as the next wave of late-stage contenders seeks differentiation through immune breadth and durability. The Phase 3 program is expected to be launched this month, following GSK’s reported success in inducing stronger immune responses in the Phase 2 setting. GSK’s strategy includes newer formulation work aimed at improving immunogenicity for seasonal use. The development comes as regulators and payers weigh long-term performance for flu vaccines, particularly in year-to-year effectiveness across circulating strains and patient groups.
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Novartis and BMS pause autoimmune CAR-T trials
Novartis halted several CAR-T trials in autoimmune diseases after observing immune-related adverse events, and Bristol Myers Squibb also paused its zola-cel program for safety review. The actions reflect growing scrutiny of off-the-shelf and next-generation cell therapies as trial programs broaden beyond oncology. Novartis’ pauses cover rap-cel development across multiple indications, while BMS’ voluntary pause applies to autoimmune testing of zola-cel. Both companies said the decisions follow safety findings requiring additional assessment. The pauses add pressure to CAR-T programs designed to target immune pathways in non-malignant settings, where benefit-risk thresholds may be more stringent and safety signals can trigger rapid operational changes.
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Genentech fenebrutinib MS readouts
Genentech reported new Phase 3 results for fenebrutinib in relapsing multiple sclerosis, claiming the FENhance 1 and 2 studies met their primary endpoints. The BTK inhibitor reduced annualized relapse rate (ARR) versus teriflunomide over 96 weeks, with reductions of 51.1% in FENhance 1 and 58.5% in FENhance 2. Genentech shared the data as a late-breaking presentation at the 2026 American Academy of Neurology (AAN) Annual Meeting. The company framed the results as potentially meaningful for disability progress and suggested comparable liver enzyme elevation rates to teriflunomide—an issue that has shaped investor focus in BTK inhibitor MS development. If the program advances, fenebrutinib could join a crowded BTK-inhibition race in MS that has included safety setbacks and trial failures across multiple sponsors.
...and 5 more selected Biotech stories in today’s full edition — or archive.
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