Shots:
CSPC has granted Radiance exclusive rights to develop & market RB-164 in the US, Canada, EU, UK, Switzerland, Norway, Iceland, Liechtenstein, Albania, Montenegro, North Macedonia, Serbia, & Australia, while retaining rights to other markets
As per the deal, CSPC will get $15M upfront, ~$150M in development & regulatory milestones and ~$1B in commercial…
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Shots:
Epitopea & Merck have entered into license & research collaboration agreement to discover Cryptigen tumor-specific antigens (TSAs) in an undisclosed solid tumor
As per the deal, Epitopea will receive an undisclosed upfront & ~$300M in milestones per product in exchange for Merck receiving exclusive development & commercialization rights to the TSA products identified…
Shots:
BMS has reported final data from P-III (CheckMate-816) trial of neoadj. Opdivo + Pt-doublet CT to treat adults with operable NSCLC (tumors ≥4cm or node positive)
The P-III (CheckMate-816) trial evaluates Opdivo (360mg, Q3W for 3 cycles) + CT vs CT alone in 358 pts with resectable stage IB to IIIA NSCLC regardless…
Shots:
Biogen & Stoke have partnered to develop & market zorevunersen for Dravet syndrome with Stoke retaining rights in the US, Canada, & Mexico while leading global development & Biogen securing marketing rights in other regions
As per the deal, Stoke will get $165M upfront, ~$385M in development & commercial milestones, & net sales-based…
Shots:
The EC has approved Eydenzelt (CT-P42, aflibercept), a biosimilar to Eylea, Stoboclo & Osenvelt (CT-P41, denosumab), a biosimilar to Prolia & Xgeva for all indications of the reference products
The P-III trial of Eydenzelt (40 mg/mL solution for injection in a vial & pre-filled syringe) vs Eylea (aflibercept) in diabetic macular edema (DME)…
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The US FDA has accepted & granted priority review to the NDA of lenacapavir (HIV-1 capsid inhibitor) for PreP in individuals at risk of HIV (PDUFA: Jun 19, 2025); MAA & EU-M4all application has been filed to the EMA
NDA was based on P-III (PURPOSE 1 & PURPOSE 2) trials assessing lenacapavir (SC; twice…
Shots:
The EC has approved Welireg for VHL-related localized RCC, CNS hemangioblastomas, or pNET unsuitable for localized procedures and advanced ccRCC post-PD-1/PD-L1 inhibitors or VEGF therapies progression across EU member states, as well as Iceland, Liechtenstein & Norway
Approval for VHL-related tumors was based on P-II (LITESPARK-004) study (n=61), showing ORR of 49% (all…
Shots:
The US FDA has granted BTD to petosemtamab + Keytruda as 1L treatment of r/m HNSCC harboring PD-L1 (CPS ≥ 1) in adults
BTD was backed by interim data from ongoing P-I/II trial evaluating petosemtamab + Keytruda in mentioned pts that showed 67% response rate in 24 evaluable pts with further data presented…
Shots:
The US FDA has granted BTD to lacutamab for the treatment of adults with r/r sézary syndrome after receiving ≥2L of therapy incl. mogamulizumab
Designation was based on P-I as well as P-II (TELLOMAK) trial data, showing efficacy & favorable safety in pts who were heavily pre-treated with mogamulizumab
Additionally, Lacutamab (anti-KIR3DL2…
Shots:
The P-III (CheckMate -9ER) trial assessed Cabometyx + Opdivo vs sunitinib in 651 pts with previously untreated advanced RCC
At 67.6mos. mFU, study showed improved mPFS (16.4 vs 8.3mos.), OS (46.5 vs 35.5mos.), ORR (55.7% vs 27.4%) & DOR (22 vs 15.2mos.), while in IMDC risk groups: favorable (n=146; mPFS: 21.4 vs 12.8mos.; mOS:…

