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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…
NEWS
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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CivicaScript has reported that Insulin Glargine-yfgn and Ustekinumab-aauz, biosimilar versions of Lantus and Stelara, are now available in the US
Civica insulin glargine-yfgn is an interchangeable Lantus® insulin for adults and children with diabetes, developed through a Civica-led collaboration. It is marketed nationally by CivicaScript and branded as CalRx in California through the state’s CalRx program
Ustekinumab-aauz is an IL-12/23 antagonist indicated for select…
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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…
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The NEJM published results from the P-I/II study of Denali Therapeutics’ tividenofusp alfa (DNL310) for the treatment of Hunter syndrome (MPS II)
The study evaluated treatment in 47 ERT-naïve (n=15) and previously treated (n=32) study participants (aged 0.3–13 [median, 5] years) demonstrating reduced levels of mean CSF levels of HS, mean urine HS levels,…
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BioAtla and GATC Health announce into a $40M special purpose vehicle (SPV) transaction to advance ozuriftamab vedotin (Oz-V), a CAB-ROR2-ADC, into a registrational P-III study for 2L+ oropharyngeal squamous cell carcinoma (OPSCC)
Under the agreement, BioAtla will receive $5M upfront to support operations and P-III study execution, with the remaining $35M expected to close…

