Shots:
The US FDA has issued a CRL related to the BLA for AVT05, a biosimilar version of Simponi (golimumab), in PFS & autoinjector formulations
The CRL noted certain deficiencies from the FDA’s Jul 2025 pre-license inspection of Alvotech’s Reykjavik facility that must be resolved before AVT05 BLA approval, though no other issues were found,…
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EVOQ Therapeutics has entered into a collaboration & license agreement with Sanofi to advance EVOQ’s NanoDisc tech in immunology
As per the deal, both companies will jointly lead research activities, with Sanofi responsible for global development & commercialization efforts. In exchange, EVOQ will receive over $500M, incl. upfront, preclinical, development & sales milestones, with tiered…
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BioCryst Pharmaceuticals has entered into a definitive agreement to acquire Astria Therapeutics, strengthening its allergic & immunology portfolio
As per the deal, Astria shareholders will receive $8.55 in cash + 0.59 BioCryst shares, valuing Astria at $13/share with an enterprise value of ~$700M (equity value: ~$920M), plus Astria shareholders will hold ~15% of pro…
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Hikma Pharmaceuticals & Celltrion have entered into exclusive licensing agreements for various biosimilar candidates across the Middle East & North Africa (MENA) region, expanding their previous partnerships
The agreement will include the commercialization of 6 biosimilars to expand access across multiple therapeutic areas, incl. allergic diseases, ophthalmology, skeletal-related disorders, immune diseases & oncology
As…
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Algen has entered into a multi-target collaboration with AstraZeneca to accelerate novel immunology target discovery, leveraging the AlgenBrain platform
As per the deal, AstraZeneca will receive exclusive rights to develop and commercialize therapies for selected targets identified through the partnership in exchange for ~555M incl. upfront, development, regulatory & commercial milestone payments
AlgenBrain models disease…
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Monte Rosa has collaborated with Novartis to develop novel degraders for immune-mediated diseases, leveraging Monte Rosa’s QuEEN discovery engine
As per the deal, Novartis will gain an exclusive license to an undisclosed discovery target & options to license 2 programs from Monte Rosa’s preclinical immunology portfolio
The deal is valued at ~$5.7B, with Monte…
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VantAI has entered into a strategic research collaboration with Halda Therapeutics to advance the discovery & development of selective proximity-based therapies for cancer & immunology indications
As per the deal, VantAI will receive over ~$1B incl. upfront, research support, development & commercial milestones as well as net sales-based tiered royalties
VantAI will use its…
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XtalPi has entered into a strategic collaboration with DoveTree Medicines to identify novel therapeutics across oncology, immunology, inflammation, neurology, & metabolic diseases, leveraging XtalPi's de novo drug discovery platform
As per the deal, DoveTree will gain exclusive global rights to develop & commercialize multiple therapeutics from the collaboration, in exchange for a $51M upfront,…
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Otsuka Pharmaceutical has entered into an agreement with Cantargia for the acquisition of all assets related to its P-I IL-1RAP antagonist program, CAN10
Otsuka Pharmaceutical will handle global development, regulatory approvals, manufacturing, & commercialization of CAN10. Otsuka has also acquired 3G5 as a backup antibody & holds exclusive negotiation right for next-gen IL-1RAP antibodies…
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Xcell Biosciences entered into a strategic collaboration with ThermoFisher Scientific to advance the development of Treg and TIL cell therapies for autoimmune and solid tumor treatments
The joint research aims to develop methodologies for enhancing the efficacy of Tregs and TILs, while streamlining and scaling cell therapy manufacturing for improved accessibility and reproducibility across…

