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Recordati and Moderna Collaborate To Develop And Commercialize mRNA 3927 in a ~$160M Deal

Shots: Recordati has entered into a collaboration & license deal with Moderna to develop & commercialize mRNA-3927 globally for the treatment of propionic acidemia As per the deal, Moderna will continue to co-develop mRNA-3927 with Recordati, while Recordati will lead global commercialization if approved. In exchange, Moderna will receive $50M upfront, ~$110M in development &…
January 30, 2026

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KORU Medical Systems Receives the US FDA Clearance for FreedomEDGE System to Deliver Rystiggo in gMG Patients

Shots: The US FDA has granted 510(k) clearance to FreedomEDGE infusion system to subcutaneously administer Rystiggo (rozanolixizumab-noli) in generalized myasthenia gravis (gMG) patients FreedomEDGE Infusion System enables efficient large-volume SC drug delivery, expanding from home use to clinic-based care to deliver life-changing therapies across various care settings The system supports SC drugs with varying viscosity, flow…
January 30, 2026

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NEXTBIOMEDICAL’s Nexsphere-F Receives Health Canada Approval For Musculoskeletal Pain Embolization

Shots: Health Canada has approved Nexsphere-F for the treatment of musculoskeletal pain embolization Nexsphere-F has launched the pivotal RESORB trial in the US post-IDE approval in 126 knee osteoarthritis pts comparing genicular artery embolization vs corticosteroid injections, with enrollment expected to complete in H1’26 Nexsphere-F uses resorbable microsphere tech to temporarily block abnormal blood flow…
January 30, 2026

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Summit Therapeutics Reports the US FDA’s BLA Acceptance for Ivonescimab to Treat EGFRm Non-Squamous NSCLC

Shots: The US FDA has accepted BLA of ivonescimab + CT for the treatment of EGFR-mutated locally advanced or metastatic non-squamous NSCLC post-TKI therapy (PDUFA: Nov 14, 2026) BLA was supported by P-III (HARMONi) trial assessing ivonescimab + Pt-doublet CT vs PBO + Pt-doublet CT in pts with EGFR-mutated, locally advanced or metastatic NSCLC who…
January 30, 2026

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Repertoire Immune Medicines and Eli Lilly Enter ~$1.9B Deal to Develop Tolerizing Therapies for Autoimmune Diseases

Shots: Repertoire has entered into a strategic collaboration with Eli Lilly to develop tolerizing therapies for multiple autoimmune diseases Repertoire will use its DECODE TCR–epitope discovery platform to identify candidates & lead collaboration activities through nomination, after which Lilly will oversee clinical development, manufacturing, regulatory activities, & commercialization Under the terms, Repertoire will receive $85M…
January 29, 2026

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Seamless Therapeutics and Eli Lilly Forge ~$1.12B Deal to Develop Hearing Loss Therapies

Shots: Seamless has entered into a strategic global research collaboration & licensing deal with Eli Lilly to develop & commercialize programmable recombinase-based therapies for hearing loss using Seamless’ proprietary recombinase platform Under the deal, Seamless will design site-specific recombinases to correct hearing-loss–related gene mutations, while Lilly will receive an exclusive license to advance these programmed…
January 29, 2026

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nChroma Bio Reports First Patient Dosing in P-I/II Trial of CRMA-1001 for HBV Infection

Shots: nChroma Bio has dosed the first patient with CRMA-1001, an epigenetic silencer, in a P-I/II trial for the treatment of hepatitis B virus (HBV) infection The open-label study is evaluating the safety, tolerability, PK/PD, & efficacy of CRMA-1001 in adults with CHB across single & multiple-ascending dose cohorts, with enrollment ongoing Additionally, the company…
January 29, 2026

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