Shots:
Ikarovec has entered into an exclusive worldwide option agreement for VectorBuilder’s AAV capsid technology to be used with Ikarovec’s IKAR-003 for intermediate age-related macular degeneration (AMD)
As per the deal, following successful tech evaluation, Ikarovec will lead the clinical development & commercialization of IKAR-003, with the proposed transaction for its intermediate AMD potential expected…
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The US FDA has received an NDA of rusfertide (SC) for the treatment of adults with polycythemia vera (PV)
NDA was followed by 32wk. primary analysis & 52wk. data from the global P-III (VERIFY) trial (n=293) as well as P-II (REVIVE) study, where VERIFY met its 1EP & all key 2EPs, showing higher response…
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Health Canada has approved Redemplo as an adjunct to diet to reduce triglycerides (TGs) in adults with FCS who had an inadequate response to standard triglyceride lowering therapies
Approval was based on the P-III (PALISADE) trial assessing Redemplo (25mg & 50mg, SC, Q3M) vs PBO in 75 adults with genetically confirmed/clinically diagnosed FCS. Pts…
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The P-III (frontMIND) trial assessed Monjuvi (Minjuvi in EU) + lenalidomide & R-CHOP vs R-CHOP as the 1L treatment in ~900 adults with previously untreated DLBCL (IPI score of 3-5 for pts >60yrs or aaIPI of 2-3 for pts ≤60yrs.)
Trial met its 1EP of improved PFS by investigator assessment & achieved its key…
Earendil Labs and Sanofi Forge ~$2.56B Deal to Advance Bispecific Antibodies for Autoimmune Diseases
Shots:
Earendil Labs has entered into a strategic collaboration with Sanofi to advance bispecific candidates for autoimmune & inflammatory diseases using Earendil's discovery platform
Under the deal, Earendil Labs will identify & optimize bispecific antibody candidates for autoimmune & inflammatory disease targets, while Sanofi will handle the development & worldwide commercialization of the products
As…
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The US FDA has accepted sBLA & granted priority review to Tzield (teplizumab-mzwv) to delay of the onset of stage 3 T1D in pts (≥1yr.) diagnosed with stage 2 T1D (PDUFA: Apr 29, 2026)
sBLA was supported by an interim 1yr. data from the ongoing P-IV (PETITE-T1D) trial assessing the safety & PK of…
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The Chinese NMPA has approved Nucala as an add-on maintenance treatment of adults with inadequately controlled COPD characterised by eosinophilic phenotype based on the P-III (MATINEE & METREX) trial; EMA filing is under review
MATINEE assessed Nucala (100mg, SC, Q4W) vs PBO in COPD pts (n=804) with type 2 inflammation while METREX evaluated it…
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FDA has granted IND clearance to initiate its P-II trial of ASC30 (40, 60 & 80mg) vs PBO in ~100 pts with type 2 diabetes mellitus, with enrolment expected to begin in Q1’26
Trial will assess mean change in HbA1c up to 13wks. as 1EP & 2EPs will incl. mean change in fasting blood…
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Insilico Medicine has entered into a multi-year R&D collaboration with Servier to identify & develop novel oncology therapeutics for challenging targets using Insilico's Pharma.AI
As per the deal, Servier will share R&D costs &, upon successful identification of potential candidates, assume responsibility for clinical validation, regulatory engagement, & global commercialization of the resulting oncology drug candidates…
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HUTCHMED has initiated P-III portion of P-II/III trial of the combination of surufatinib, camrelizumab, nab-paclitaxel & gemcitabine (S+C+AG) as the 1L treatment of metastatic PDAC in China, with the first patient receiving the dose on Dec 30, 2025
Trial will evaluate the combination against nab-paclitaxel + gemcitabine in ~400 PDAC adults who have not…

