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The US FDA has approved Welireg + Lenvima for the treatment of adults with advanced renal cell carcinoma with a clear cell component (ccRCC) following a PD-1 or PD-L1 inhibitor
Approval was based on the P-III (LITESPARK-011) trial assessing Welireg (120mg, PO, QD) + Lenvima (20mg, PO, QD) vs cabozantinib in 747 pts with advanced…
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The MHLW has approved Leqembi Pen (SC autoinjector) administered as 500mg given QW as two pens, each delivered in ~15secs, for the treatment of early Alzheimer's disease
Approval was supported by 18mos. P-III Clarity AD data in pts with mild cognitive impairment (MCI) due to AD or mild AD dementia & multiple SC administration…
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The NMPA has approved Leqembi (SC autoinjector/SC-AI) as an initiation dose administered as 500mg given QW as two consecutive 250mg injections, each delivered in ~15secs, for the treatment of early Alzheimer's disease
Approval was supported by 18mos. P-III Clarity AD data & multiple SC administration sub-studies (incl. Chinese cohort), with SC-AI 500mg (QW) showing…
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CORE Biomedicine has entered into a licensing agreement with Eisai, securing exclusive global rights to develop & commercialize multiple preclinical oncology programs
As per the deal, CORE will obtain exclusive, global rights to certain preclinical oncology programs spanning distinct targets & biological pathways, providing CORE with a broad pipeline to develop next-generation precision medicines…
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The US FDA has approved an sBLA for Leqembi Iqlik (lecanemab‑irmb, SC) as an initiation dose administered as 500mg given QW as two 250mg injections, each delivered in ~15secs for the treatment of early Alzheimer's disease
Approval was supported by clinical data across multiple studies, with Clarity AD LTE sub-studies showing QW SC Leqembi…
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Eisai & Henlius have entered into an exclusive commercialization & co-exclusive development & manufacturing license agreement for serplulimab (Hetronifly in the EU) in Japan
As per the deal, Eisai will obtain exclusive rights to commercialize serplulimab in Japan in exchange for $75M upfront, ~$80.01M in regulatory milestones, ~$233.3M in sales milestones, with double-digit royalties…
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The Japanese PMDA has received NDA for Leqembi SC autoinjector to treat adults with early Alzheimer’s disease (AD)
NDA is supported by sub-studies from the P-III (Clarity AD) OLE study in pts with mild cognitive impairment due to AD or mild AD dementia, showing that Leqembi (500mg, SC: two 250mg injections) administered QW, provided exposure equivalent to Q2W IV…
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The UK’s MHRA has approved Leqembi (IV, Q4W) as a maintenance therapy for early Alzheimer’s pts after completing 18mos. of Q2W Leqembi treatment
Leqembi is approved in 51 countries for early AD & under review in 9, while the Q4W maintenance is approved in the UK, China, the US, & others, with 4 applications…
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Health Canada has approved Leqembi with conditions for adults with mild cognitive impairment or mild dementia due to early Alzheimer’s disease who are ApoE ε4 non-carriers or heterozygotes with confirmed amyloid pathology
Approval was based on the P-III (Clarity AD) trial assessing Leqembi vs PBO in pts with MCI or mild dementia due to…
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Eisai & Biogen have reported EU launch of Leqembi, starting with Austria on Aug 25, 2025 & Germany on Sep 1, 2025, following EC approval in Apr 2025
Approval was based on the P-III (Clarity AD) trial assessing Leqembi (n=757) vs PBO (n=764) in pts with MCI or mild dementia due to AD &…

