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Innovent
NEWS

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…
June 4, 2026

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NEWS

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…
June 4, 2026

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NEWS

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…
June 4, 2026

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NEWS

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,…
June 4, 2026

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NEWS

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…
June 4, 2026

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NEWS

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…
June 3, 2026

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Celcuity
NEWS

Celcuity Reports the P-III (VIKTORIA-1) Trial Data on Gedatolisib Combination for HR+/HER2- PIK3CA Mutant Advanced Breast Cancer

Shots: Celcuity has reported the PIK3CA mutant cohort data from P-III (VIKTORIA-1) study of gedatolisib + fulvestrant ± palbociclib vs SoC in HR+/HER2- advanced breast cancer pts who progressed on or after treatment with CDK4/6 inhibitor & an aromatase inhibitor In the cohort, the gedatolisib triplet showed mPFS of 11.1 vs. 5.6mos., & an ORR…
June 3, 2026

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NEWS

Signati Medical Receives FDA IDE Approval for Pivotal Trial of Separo Vasectomy System

Shots: The FDA has granted IDE approval to initiate a multi-center pivotal study evaluating the Separo Vessel Sealing System vs standard mucosal cautery vasectomy The trial will enroll 120 adult male subjects across ~5 US centers, with the primary endpoint measuring azoospermia or rare non-motile sperm (≤100,000/mL) within 6mos. following the procedure The Separo System…
June 3, 2026

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