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Otsuka Pharmaceutical Reports P-III (VISIONARY) Trial Data on Voyxact for IgA Nephropathy (IgAN)

Shots: Otsuka reported the ongoing P-III (VISIONARY) trial data assessing Voyxact (sibeprenlimab; n= 320) vs PBO (n=152) in preserving kidney function in IgAN pts over a 24mos. treatment period At 12mos., Voyxactimproved kidney function with a mean eGFR change from baseline of +0.7 vs -4.8 mL/min/1.73 m², achieving the KDIGO treatment goal of limiting annual kidney…

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Innovent

Innovent Reports the P-III Trial Results on Arcotatug Tavatecan in G/GEJ Adenocarcinoma 

Shots: Innovent has reported the P-III (G-HOPE-001) of arcotatug tavatecan (IBI343/TAK-921) vs investigator-selected therapy in pts with Claudin 18.2 positive, locally advanced unresectable or metastatic G/GEJA who have received ≥2 prior therapies Trial met its 1EP of improved PFS in the interim analysis & showed a favorable safety profile; data to be published in future…

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Alvotech Reports the US FDA’s BLA Resubmission for AVT05 (Bisomilar, Simponi and Simponi Aria) and AVT06 (Biosimilar, Eylea)

Shots: The US FDA has received resubmitted BLA of AVT05, a biosimilar version of Simponi & Simponi Aria, and AVT06, a biosimilar to Eylea 2mg (aflibercept)  Resubmissions follow Alvotech’s response to the FDA’s PAAL regarding its Reykjavik facility, alongside responses to observations from a May 2026 routine cGMP inspection & ongoing enhancements to quality systems…

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Lundbeck Partners with Cradle to Accelerate AI-Driven Biotherapeutics Discovery

Shots: Lundbeck and Cradle entered a partnership to leverage AI-powered protein engineering for the discovery and optimization of biotherapeutics, with an initial focus on 2 antibody programs targeting CNS diseases Lundbeck will deploy Cradle’s generative AI platform in its first end-to-end AI-guided protein engineering workflow, using iterative feedback from experimental data to discover & optimize…

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CytomX and Regeneron Expand Tumor-Activated Bispecific Cancer Therapy Collaboration in Potential ~$4B Deal

Shots: CytomX has expanded its collaboration & licensing agreement with Regeneron to develop conditionally-activated bispecific cancer therapies using CytomX’s Probody platform & Regeneron’s Veloci-B BsAb development platform As per the expanded deal, the companies will continue joint discovery efforts to identify & validate conditionally active BsAbs, with Regeneron assuming responsibility for all preclinical & clinical development, commercialization,…

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Alnylam and Inceptive Enter ~$2B Collaboration to Accelerate AI-Powered Discovery of RNAi Therapeutics

Shots: Alnylam Pharmaceuticals & Inceptive Nucleics have entered into a strategic collaboration to accelerate the discovery of novel RNAi therapeutics The collaboration is valued at up to $2B, with $30M upfront, incl. cash & an equity investment in Inceptive. Inceptive will also receive additional preclinical, regulatory, & commercial milestone payments Collaboration combines Alnylam’s RNAi expertise…

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Ascidian and Eli Lilly Partner to Advance RNA Exon Editors for Devastating Kidney Diseases in a ~$1.9B Deal

Shots: Ascidian has entered a global research & licensing agreement with Eli Lilly to discover & develop therapies for undisclosed monogenic kidney diseases, with an option to expand the collaboration to additional targets As per the deal, Lilly will obtain exclusive target-specific rights to Ascidian’s RNA exon editing tech for undisclosed targets, with Ascidian leading…

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