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What’s in Today’s Brief? (February 10th Preview)
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Lilly buys Orna: $2.4B bet on in vivo CAR‑T
Eli Lilly agreed to acquire Orna Therapeutics in a transaction valued at up to $2.4 billion to gain an in‑vivo CAR‑T capability built on circular RNA and LNP delivery. Lilly framed the deal as a strategic entry into cell therapies that can be manufactured inside patients, advancing ORN‑252 — a CD19‑targeting, clinical‑trial‑ready candidate for B‑cell autoimmune diseases. The acquisition folds Orna’s platform into Lilly’s genetic‑medicine ambitions and follows a broader industry wave of large pharma buying in‑vivo cell engineering assets. Orna’s technology centers on engineered circular RNA intended to produce more durable protein expression than linear mRNA and paired lipid nanoparticles for systemic delivery. Lilly highlighted potential cross‑portfolio synergies across immunology and genetic medicine while noting the transaction will be reflected in its financials upon closing. Orna management emphasized the potential to scale in‑body CAR‑T approaches that avoid ex‑vivo manufacturing burdens.
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FDA rejects Regenxbio therapy: Hunter syndrome bid turned down
The FDA issued a complete response letter rejecting Regenxbio’s RGX‑121 gene therapy for Hunter syndrome, citing concerns about the development program’s ability to define the patient population and the reliance on a biomarker endpoint. Regenxbio signaled it will pursue a resubmission with longer‑term data but described the decision as devastating for families of boys with severe disease. Regulatory officials raised questions about the use of heparan sulfate as a surrogate endpoint and the trial’s control strategy, prompting the agency to ask for more robust efficacy data. The rejection follows earlier agency scrutiny and clinical holds on related Regenxbio programs and underscores heightened FDA scrutiny of biomarker‑driven accelerated approvals for one‑time genetic medicines.
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Novo Nordisk sues Hims – Wegovy compounding clash escalates
Novo Nordisk filed patent litigation against Hims & Hers over a compounded pill version of semaglutide marketed by Hims, accusing the telehealth company of unlawfully mass‑marketing an unapproved copycat of Wegovy. Novo said the compounded product lacks the SNAC absorption technology used in the approved oral formulation and warned of safety and efficacy risks. Federal scrutiny followed: FDA Commissioner Marty Makary publicly pledged enforcement action against companies mass‑marketing unauthorized copycat drugs. The legal and regulatory pushback signals intensified industry and regulator focus on compounding and telehealth distribution models for GLP‑1 therapies.
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Medicare covers Personalis MRD test: lung cancer surveillance win
The US Centers for Medicare & Medicaid Services granted coverage for Personalis’ NeXT Personal molecular residual disease (MRD) test for surveillance in stages I–III non‑small cell lung cancer. The decision follows clinical evidence generated with the TRACERx consortium and builds on data published in Nature Medicine that demonstrated the assay’s sensitivity tracking tumor‑specific mutation fingerprints through whole‑genome sequencing and noise suppression techniques. Personalis said Medicare coverage expands patient access and will catalyze commercial growth; the company already secured previous Medicare coverage in breast cancer surveillance. The decision highlights payer willingness to support genomic MRD assays when supported by consortium datasets and peer‑reviewed performance metrics.
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Circular Genomics licenses circRNA Alzheimer’s IP from WUSTL, MDC
Circular Genomics secured exclusive commercial rights to intellectual property from Washington University in St. Louis and the Max Delbrück Center covering circular RNA (circRNA) biomarkers for Alzheimer’s disease. The licenses grant access to foundational IP on identifying and measuring circRNA signatures across the Alzheimer’s continuum, from preclinical stages through symptomatic disease. Circular Genomics said the deals strengthen its circRNA platform and position the company for partnerships and commercialization in neurodegenerative diagnostics. The move underscores growing industry interest in noncoding RNA biomarkers and competitive positioning around early detection tools for Alzheimer’s.
...and 5 more selected Biotech stories in today’s full edition — or archive.
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