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The US FDA has accepted the sBLA under Project Orbis & granted priority review to Jemperli in previously untreated stage II/III dMMR/MSI-H locally advanced rectal cancer (PDUFA: Feb 2027), with eligibility for an earlier decision through the NPV program
sBLA was based on the global P-II (AZUR-1) trial assessing Jemperli (dostarlimab) monotx. (500mg, IV, Q3W…
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Ono has entered into a drug discovery partnership & option agreement with Mediar Therapeutics to develop novel antibody therapeutics for fibro-inflammatory diseases
As per the deal, Mediar will conduct research using its fibrosis-focused research platform, while Ono will gain exclusive worldwide option rights to select candidates for development, manufacturing, & commercialization
The partnership will…
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argenx has entered into a definitive agreement to acquire Forte Biosciences, strengthening argenx’s innovative immunology portfolio with FB102
As per the deal, argenx will acquire Forte Biosciences for $77/share in cash, representing a total equity value of ~$2.2B; closing is expected in Q3’26
FB102 is an anti-CD122 antibody showing clinical PoC in vitiligo & celiac disease, with…
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Royalty Pharma will pay Neurimmune up to $425M, incl. $125M upfront, in exchange for a 3% to 4% royalty on worldwide net sales of AstraZeneca’s cliramitug
Royalty Pharma will pay Neurimmune an additional $125M in cash in Q1’27, with the remaining $175M contingent on the achievement of specified clinical & regulatory milestones
Cliramitug is…
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Samsung Biologics has launched an all-cash public tender offer to acquire 100% of the fully diluted share capital of PolyPeptide, expanding its capabilities beyond antibodies & ADCs to include peptide therapeutics
As per the deal, PolyPeptide will receive CHF 44.31 (~$54.8) in cash per share, representing an implied equity value of ~CHF 1.46B (~$1.8B);…
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Chai Discovery has raised $400M in a Series C round to develop AI models that predict & engineer molecular interactions to speed preclinical drug discovery
The Series C round, valuing Chai at $3.8B, was led by Index Ventures with participation from Kleiner Perkins, Sequoia Capital, Dimension, and several new and existing investors
The company’s…
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GSK has reported global P-II (AZUR-1) trial data assessing Jemperli (dostarlimab) (500mg, IV, Q3W for 9 cycles) in 154 pts with stage II/III mismatch repair deficient/microsatellite instability-high (dMMR/MSI-H) locally advanced rectal cancer
Trial met its 1EP, with a meaningful & sustained clinical complete response rate at 12mos. Interim AZUR-1 data will be shared with global…
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LabGenius has entered into a multi-year research collaboration, option & licensing agreement with LG Chem to identify next-generation multispecific antibodies for difficult-to-treat cancers, leveraging LabGenius’ AI/ML-driven antibody discovery platform, EVA
As per the licensing deal, LabGenius will lead preclinical research, incl. in vitro efficacy studies, after which LG Chem will conduct further preclinical development, incl.…
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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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BI has entered into a global licensing agreement with Immunitas for a preclinical antibody program being developed for chronic inflammatory & autoimmune diseases
As per the deal, BI will obtain global rights to develop, manufacture, & commercialize the antibody program in exchange for an upfront payment, up to €407.5M (~$479.6M) in development, regulatory, &…

