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As of Feb 10, 2026 (mFU: 8.5mos.), the P-III trial assessing daraxonrasib (300mg, QD, PO; n=248) vs CT (n=252) in previously treated metastatic PDAC, regardless of RAS mutation, met all 1 & key 2EPs, showing benefits in both the RAS G12 mutant (daraxonrasib n=228; CT n=231) & overall population
Daraxonrasib improved OS by 60% in…
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Oscotec has granted Agios exclusive global rights to cevidoplenib (PO), a spleen tyrosine kinase inhibitor, across all indications, incl. immune thrombocytopenia (ITP)
As per the deal, Agios will assume full development & commercialization costs, while Oscotec will receive $25M upfront, ~$140M in development & regulatory milestones across ~3 indications in the US & EU,…
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The US FDA has approved ECoG Assistant, an AI-powered clinician tool designed to support epilepsy management using data from the RNS System, with NeuroPace debuting the tool at ASSFN’26
ECoG Assistant was developed using 124,450 epileptologist-labeled intracranial EEG records & identifies ECoGs of Interest, enabling clinicians to review long-term EEG trends & circadian activity…
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Lilly's global P-III (LIBRETTO-432) trial assessed Retevmo (selpercatinib; 160mg, BID) vs PBO in 151 pts with early-stage (IB-IIIA) RET fusion-positive NSCLC following completion of definitive radiotherapy or surgery with curative intent, & other adjuvant therapy
Trial met the 1EP, improving the EFS by 83% in stage II–IIIA RET-positive NSCLC (n=109), with 24mos. EFS rates of…
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The Akeso's global P-III (HARMONi-6/AK112-306) trial assessed ivonescimab + CT vs Tevimbra + CT to treat pts (n=532) with 1L sqNSCLC, meeting its 2EP of improved OS
As of Feb 27, 2026 (mFU: 21.36mos.), ivonescimab + CT reduced the death risk by 34%(mOS: 27.9 vs 23.7mos.), with 12 and 24mos. OS rate of 78.9%…
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Hanmi Pharm has granted Eli Lilly exclusive global rights (excl. Korea) to develop, manufacture & commercialize sonefpeglutide, a GLP-2 analog incorporating Hanmi's long-acting platform tech, Lapscovery
As per the deal, Hanmi will receive $75M upfront & up to $1.185B in clinical development, regulatory approval, and commercialization milestone payments, with royalties following product launch
Hanmi…
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The US FDA has granted BTD to Merck's calderasib (MK-1084) + Keytrudafor the 1L treatment of pts with advanced or metastatic NSCLC with KRAS G12C-mutation & expressing PD-L1 (TPS ≥1%)
Designation was supported by P-I (KANDLELIT-001) trial data showing calderasib monotx. (n=21) achieved a 38% ORR, calderasib + Keytruda (n=69) delivered an ORR of 77%, while…
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Altimmune has reported 48wk. data from the P-IIb (IMPACT) trial assessing pemvidutide (1.2 or 1.8mg, SC, QW) vs PBO in 212 pts with MASH & fibrosis stages F2 or F3, with & without diabetes
Pemvidutide (1.8mg) showed a reduction in triglycerides by 23.7%, total cholesterol by 15.4%, BMI by 3kg/m², waist circumference by 5.3cm,…
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The US FDA has accepted NDA & granted priority review to Cogent's bezuclastinib + sunitinib for the treatment of pts with GIST who were treated with imatinib, with no advisory committee meeting planned yet (PDUFA: Nov 30, 2026)
NDA was supported by the P-III (PEAK) trial data assessing bezuclastinib + sunitinib vs sunitinib monotx.…
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Samsung Bioepis to directly commercialize Opuviz 40 mg/mL solution for injection in a vial, a biosimilar version of Eylea (aflibercept), across the EU
Opuviz is indicated to treat wet age-related macular degeneration (AMD), visual impairment due to macular oedema secondary to retinal vein occlusion (RVO; branch or central RVO), diabetic macular oedema (DME), and…

