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Sobi has reported pooled subgroup analysis (n=455) from P-III (CORE: n=617 & CORE2: n=446) trials assessing Tryngolza (olezarsen; 50 or 80mg, SC, Q4W) vs PBO in adults with severe hypertriglyceridemia (sHTG) & triglyceride (TG) levels ≥500 mg/dL
Trial showed PBO-adjusted TG reductions of 66% (80mg) & 59% (50mg) at 6mos. in pts with TGs…
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Trial assessed Lilly's VERVE-102 (IV; 0.3, 0.45, 0.6, 0.7, 0.8 & 1mg/kg) in 35 adults with HeFH or premature coronary artery disease who required additional LDL-C lowering despite maximally tolerated oral lipid-lowering therapy
Single infusion of VERVE-102 led to dose-dependent PCSK9 reductions of 51% (0.3mg/kg) to 88% (1mg/kg), with corresponding mean LDL-C reductions of…
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OSE Immunotherapeutics has reported the topline P-II (TEDOVA/GINECO-OV244b/ENGOT-ov58) trial results evaluating Tedopi (OSE2101) ± Keytruda as a maintenance treatment in pts with Pt-sensitive recurrent ovarian cancer (PSOC)
Trial enrolled 185 pts with PSOC who progressed after or were ineligible for PARP inhibitors & Avastin. Pts achieving CR, PR, or stable disease after Pt-based therapy…
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Merck has reported global P-III (TroFuse-005) trial data assessing sac-TMT (4 mg/kg, Q2W) vs doxorubicin/paclitaxel in 776 pts with endometrial carcinoma & carcinosarcoma who have received prior Pt-based CT & anti-PD-1/anti-PD-L1 immunotherapy either together or separately
Trial met its 1EP of improved OS & PFS in the above pts, plus it also reached its key…
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Trial assessed Lilly’s retatrutide (4, 9 & 12mg) with dose escalation vs PBO in adults with obesity/overweight & ≥1 weight-related comorbidity & without diabetes, meeting 1EP of 19% (4mg), 25.9% (9mg) & 28.3% (12mg) weight loss at 80wks.
In 2EPs, retatrutide reduced waist circumference by 16.3cm (4mg), 21.8cm (9mg), & 24.1cm (12mg) vs 3.6cm.…
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Pfizer has reported its P-II trial data assessing the safety, tolerability & immunogenicity of a 4 dose series of PF-07872412 (25vPnC) vs 4 doses of PREVNAR 20 at mos. 2, 4, 6 & 12-15 in infants
25vPnC vaccine generated higher immune responses against serotype 3 vs Prevnar 20, with geometric mean titers 8.8-fold higher…
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UCB has reported the (BE BOLD) trial data assessing Bimzelx(bimekizumab-bkzx) vs Skyrizi(risankizumab-rzaa) in 553 adults living with active psoriatic arthritis (PsA)
Trial met its 1EP, with 49.1% pts achieving ACR50 at Wk. 16 vs 38.4%. The first ranked 2EP, MDA was numerically higher at Wk. 16 (43% vs 39.9%), but did not reach statistical…
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Vincentage Pharma has reported topline P-III trial results evaluating VCT220 (120 0r 160mg, QD, PO) vs PBO for 52wks. in 840 Chinese adults with obesity or overweight with ≥1 weight-related comorbidity
The trial met its 1EP, showing mean body weight reduction of -12.2% and -12.4% in the 120 & 160mg groups, respectively, vs -1.3% for…
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The US FDA has granted Priority Review to Bayer’s Hyrnuo (sevabertinib) for the 1L treatment of adults with locally advanced or metastatic NSCLC harboring HER2 (ERBB2) TKD-activating mutations & no prior systemic therapy
sNDA was supported by preliminary data from Cohort F of the P-I/II (SOHO-01) trial evaluating the efficacy & safety of Hyrnuo…
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Sanofi has reported the P-II (ElevAATe) study data assessing efdoralprin alfa (Q3W or Q4W) vs SoC plasma-derived augmentation therapy (pdAAT; QW) in 97 pts with AATD-related emphysema
Efdoralprin alfa achieved a mean increase in fAAT trough levels of 24.1μM (Q3W) & 16.8μM (Q4W) vs 7.6μM at Wk. 32, with Q3W meeting the 1EP, while…

