SNAPSHOT

Lilly snaps up Orna for $2.4B to push CAR-T therapies inside the body

Eli Lilly is acquiring Orna Therapeutics for up to $2.4 billion, gaining access to Orna’s circular RNA platform to develop in vivo CAR-T cell therapies, starting with autoimmune disease programs.

Why it matters: The deal positions Lilly in one of biotech’s most competitive frontiers: simpler, potentially cheaper CAR-T therapies made directly inside patients.

Backstory: Traditional CAR-T therapies require extracting, engineering, and reinfusing a patient’s cells, a process that is costly and logistically challenging. In vivo CAR-T aims to generate these engineered cells directly in the body using RNA-based approaches.

Big picture: Lilly joins peers like AbbVie, Gilead, Bristol Myers Squibb, and AstraZeneca in betting billions that in vivo CAR-T could dramatically expand access to cell therapies, especially in autoimmune diseases where patient populations are large.

Zoom in: Orna’s lead program, ORN-252, targets CD19 and is described by Lilly as “clinical trial-ready,” with an initial focus on B-cell–driven autoimmune diseases. Orna’s technology combines engineered circular RNA with lipid nanoparticles to drive more durable protein expression than conventional RNA approaches. Founded in 2021 with $100 million, Orna built its platform on MIT research and later raised $221 million in Series B funding, partnered with Merck & Co. and Vertex, and acquired Renegade Therapeutics.

Yes, but: For Lilly, flush with revenues from its diabetes/obesity drug Mounjaro, the deal continues an aggressive M&A streak that includes Verve Therapeutics ($1B), Ventyx ($1.2B), and Adverum. Lilly did not disclose how much of the $2.4 billion price tag is upfront versus milestone-based, but with such deep pockets, either options are not a problem.

What’s next: Lilly and Orna teams will integrate platforms and advance ORN-252 into clinical development, while expanding the pipeline of in vivo CAR-T candidates.

SNIPPETS

What’s happening in biotech today?

🏭 Phase 2 factory: Eli Lilly and Innovent Biologics have entered a new oncology and immunology collaboration featuring $350 million upfront and up to $8.5 billion in potential milestone payments, marking what Innovent describes as a move beyond traditional licensing. Innovent will use its antibody platform to discover and develop multiple programs through Phase 2, after which Lilly will license and advance the assets outside greater China, while Innovent retains China rights and earns ex-China royalties. The deal builds on six prior collaborations between the companies, reflecting continued confidence in Innovent’s R&D capabilities despite mixed past outcomes. Definitely a busy day for Lilly!

🤖 AI alliance: Takeda Pharmaceutical has entered a multiyear collaboration with AI-focused biotech Iambic Therapeutics to discover small-molecule drugs for cancer and immune or gastrointestinal diseases, in a deal that could exceed $1.7 billion in milestones and royalties. Takeda will gain access to Iambic’s AI-driven drug discovery platform and protein–receptor interaction models, reflecting a broader industry push to integrate artificial intelligence into R&D as major drugs near patent expiry. While AI drug development has produced mixed results industrywide, Iambic argues its clinical progress, including early data on a HER2-targeting cancer drug, distinguishes it within the crowded field.

💪 Not inferior: Roche has disclosed phase 3 data showing its BTK inhibitor fenebrutinib reduced the risk of disability progression in primary progressive multiple sclerosis by 12% compared with Ocrevus (standard-of-care monoclonal antibody), meeting the trial’s primary endpoint for noninferiority but not superiority. While overall efficacy was similar, fenebrutinib showed stronger effects on specific measures, notably a 26% reduction in worsening on an upper limb function test and superiority in a post hoc disability analysis. Safety data highlighted reversible liver enzyme elevations, an ongoing concern for the BTK class, though Roche reported no severe liver injury cases in this trial and plans regulatory filings after additional phase 3 results.

 🧬 Polyclonal play: CSL has entered a collaboration and option agreement with Memo Therapeutics focused on developing recombinant polyclonal IgG antibodies using Memo’s Dropzylla discovery platform, a deal carrying up to 265 million Swiss francs ($328 million) in potential value. Under the agreement, Memo will develop IgG products derived from cloned human antibody repertoires, while CSL holds an option to exclusively license resulting candidates in exchange for R&D funding, milestones, and single-digit royalties. The partnership aligns with CSL’s strategy to expand external innovation following internal restructuring and positions Memo’s technology as a scalable alternative to plasma-derived immunoglobulin therapies for rare and serious diseases.

👁️ Leakage drops: Breye Therapeutics has reported encouraging phase 1b clinical data for its lead oral candidate, danegaptide, in patients with non-proliferative diabetic retinopathy (NPDR) and macular oedema. In a 24-patient, multicentre open-label study, danegaptide was well tolerated, achieved targeted plasma levels and showed signs of biological activity, with more than half of participants demonstrating reduced retinal vascular leakage and statistically significant reductions in oedema by study end. The first-in-class small molecule is designed to stabilise retinal vasculature and prevent hyperglycaemia-driven damage, supporting Breye’s plans to advance into a phase 2 trial using regulatory disease severity endpoints.

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