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What’s in Today’s Brief? (February 10th Preview)
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Lilly buys Orna: $2.4bn bet on in vivo CAR‑T
Eli Lilly agreed to acquire Orna Therapeutics in a deal valued at up to $2.4 billion, moving the pharma into in‑vivo CAR‑T and circular RNA delivery. The transaction gives Lilly immediate access to ORN‑252, a clinical‑trial–ready CD19‑targeting in‑vivo CAR‑T candidate, and Orna’s circular RNA and LNP platform. Lilly framed the acquisition as a strategic extension of its genetic‑medicine and cell‑therapy ambitions. Orna’s technology aims to generate CAR‑T activity inside patients using engineered circular RNA and lipid nanoparticles, avoiding ex vivo manufacturing. The deal joins a wave of recent strategic buys by big pharmas to secure next‑generation in‑vivo cell engineering capabilities and accelerates Lilly’s entry into autoimmune and genetic‑medicine indications. Integration timelines, accounting treatment, and milestone structure will determine near‑term pipeline impact.
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FDA rejects Regenxbio therapy — rare‑disease program stalled
The FDA issued a complete response letter rejecting Regenxbio’s RGX‑121 for Hunter syndrome, citing concerns about surrogate endpoints, historical controls, and the robustness of the evidence package. Regenxbio said the agency agreed "in principle" with the trial design but found multiple unresolved issues and outlined potential paths including new trials or longer follow‑up. The decision follows a prior clinical hold and safety review after an unrelated trial participant developed a brain tumor, prompting FDA caution on related AAV programs. Regenxbio plans to request a meeting to discuss resubmission options; the regulator’s stance signals intensified scrutiny of gene‑therapy evidence and control strategies in ultra‑rare disorders.
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Nektar’s rezpeg holds up at 1 year — durability claim strengthens
Nektar Therapeutics reported one‑year follow‑up data showing rezpegaldesleukin sustained and in some cases deepened skin‑clearance responses in patients with moderate‑to‑severe atopic dermatitis. Both monthly and quarterly maintenance dosing preserved high EASI responses, with the company highlighting less‑frequent dosing as a potential competitive edge versus established biologics. Nektar said the Phase 2 maintenance results support its planned Phase 3 design and an FDA submission timeline targeting 2029 if later trials confirm the effect. Investors reacted positively, reflecting broader market appetite for long‑acting immunomodulators that could reduce treatment burden.
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Evommune’s EVO301 challenges Dupixent — phase II moves market
Evommune reported that EVO301, an IL‑18–binding long‑acting fusion protein, met primary endpoints in a Phase 2a atopic dermatitis study, delivering statistically significant EASI improvements versus placebo. The topline drove a sharp premarket share rally and positioned EVO301 as a potential alternative to current IL‑4/13 and IL‑13 agents. Evommune plans a Phase 2b to test subcutaneous formulations and optimized dosing; management said higher or more frequent dosing could further improve efficacy. The result tightens competition in the eczema biologic market and underscores investor interest in differentiated cytokine‑targeting approaches.
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Takeda taps Iambic’s AI — $1.7bn discovery pact
Takeda signed a multiyear discovery and technology collaboration with Iambic Therapeutics reportedly worth $1.7 billion, aiming to accelerate small‑molecule drug discovery across oncology, GI and inflammation targets. The deal gives Takeda access to Iambic’s generative and AI‑driven design tools while providing Iambic funding and validation to scale its platform. The pact reflects big‑pharma strategies to hedge internal R&D with external AI capabilities. Executives framed the arrangement as mutually reinforcing: Takeda gains computational discovery firepower; Iambic secures a large strategic partner to drive de‑risked preclinical programs toward clinical inflection points.
...and 5 more selected Biotech stories in today’s full edition — or archive.
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