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Adaptive Biotechnologies and Pfizer Sign Rheumatoid Arthritis TCR Target Discovery and Immune Data Licensing Deals
Shots: Adaptive has entered into 2 non-exclusive agreements with Pfizer, combining its T-cell receptor (TCR) discovery & immune receptor antigen-mapping platform to support Pfizer’s research across autoimmune & other disease areas As per the target discovery deal, Adaptive will identify disease-specific TCR targets in rheumatoid arthritis from Pfizer clinical samples, while Pfizer will lead development…
December 16, 2025
ADEL and Sanofi Ink ~$1.04B Global Licensing Deal for ADEL-Y01
Shots: ADEL has entered into an exclusive worldwide license agreement with Sanofi for the development & commercialization of ADEL-Y01 & related backup compounds As per the deal, ADEL will receive a non-refundable payment of $80M upfront plus development & commercial milestones, representing the total deal value of ~$1.04B, tiered royalties on net sales ranging up…
December 16, 2025
Sobi Reports the CHMP Positive Opinion of Aspaveli for C3 Glomerulopathy and Primary IC-MPGN
Shots: The CHMP has recommended Sobi's Aspaveli (pegcetacoplan) for C3 glomerulopathy (C3G) or primary immune complex membranoproliferative glomerulonephritis (IC-MPGN) pts (≥12yrs.), with EC decision expected in Q1’26 Opinion was based on P-III (VALIANT) trial assessing Aspaveli(Q2W) vs PBO in C3G or primary IC-MPGN pts (≥12yrs., n=124) for 26wks. followed by 26wk. open-label period, where all…
December 15, 2025
Insilico Medicine and TaiGen Biotechnology Partner for ISM4808 to Treat Anemia of Chronic Kidney Disease (CKD)
Shots: Insilico has entered into an exclusive out-licensing collaboration with TaiGen & its subsidiary TaiGen Biopharmaceuticals for ISM4808 to treat CKD-related anemia As per the deal, TaiGen will gain exclusive rights to ISM4808 & related forms for further development, commercialization & sub-licensing in Greater China, while Insilico will receive upfront payment, development & sales milestones, &…
December 15, 2025
Cytokinetics Reports the CHMP Positive Opinion on Myqorzo (Aficamten) for Obstructive Hypertrophic Cardiomyopathy (oHCM)
Shots: The CHMP has recommended Cytokinetics’ Myqorzo for the treatment of adults with symptomatic (NYHA, class II-III) oHCM, with EC decision expected in Q1’26 Opinion was based on P-III (SEQUOIA-HCM) trial of Myqorzo, showing improved exercise capacity vs PBO at 24wks., with increased peak oxygen uptake by 1.8 vs 0 ml/kg/min, consistent across all subgroups &…
December 15, 2025
GSK Reports the CHMP Positive Opinion of Depemokimab for Asthma with Type 2 Inflammation and CRSwNP
Shots: CHMP recommended GSK's depemokimab as add-on maintenance therapy for asthma pts (≥12yrs.) with type 2 inflammation (eosinophilic) & as add-on therapy for inadequately controlled CRSwNP, based on P-III (SWIFT & ANCHOR) trials, respectively; EC’s decision expected in Q1’26 SWIFT-1 (n=382) & SWIFT-2 (n=380) trials showed depemokimab reduced asthma exacerbations by 54% over 52wks. (1EP)…
December 15, 2025
J&J
Johnson & Johnson Reports the US FDA Approval of Akeega to Treat Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
Shots: The US FDA has approved J&J's Akeega (niraparib & abiraterone acetate tablet) + prednisone to treat adults with BRCA2-mutated mHSPC Approval was backed by the ongoing P-III (AMPLITUDE) trial assessing Akeega + prednisone/prednisolone + ADT vs PBO/abiraterone acetate with prednisone + ADT in 696 pts with deleterious germline or somatic HRR gene-altered mHSPC Trial met its…
December 15, 2025
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