Key Outcomes: LET003 (Harbour BioMed): AI-designed ACVR2A/2B mAb showed 76% fat mass reduction and 6.5% better muscle preservation vs semaglutide alone in DIO mice, advancing to clinical development Ziihera (Jazz): P3 HERIZON-GEA-01 published in NEJM demonstrating superior PFS & OS vs SOC in 1L HER2+ GEA, submitted to NCCN for guideline inclusion Arexvy (GSK): Japan’s […]

Key Outcomes: TREMFYA met primary endpoint in P3 FUZION study for perianal fistulizing Crohn’s disease – first RCT to show an approved IBD therapy works in this population Tovorafenib (OJEMDA) P3 FIREFLY-2 completed enrollment in frontline pLGG; preliminary results expected 2027 Ligufalimab triplet showed improved survival in P2 AML study with comparable safety to standard […]

Key Outcomes: ENFLONSIA (Merck) – EU approved for infant RSV prevention (single-dose injection) Blenrep combo (GSK) – China approved for 2L+ multiple myeloma; 42% reduced death risk GAZYVA sBLA (Roche) – FDA accepted for SLE; decision expected Dec 2026 TZIELD (Sanofi) – FDA expanded to infants aged 1+ for early-stage T1D delay Coartem Baby (Novartis) […]

Key Outcomes: Lilly’s Foundayo (orforglipron) – 1st GLP-1 weight-loss pill with no food/water restrictions, ~$25/mos with insurance Dupixent – EU approved for CSU in kids aged 2–11, 1st targeted therapy for this group Neffy nasal spray – 1st needle-free epinephrine approved in Canada for anaphylaxis YUVIWEL – orphan drug exclusivity granted for achondroplasia in kids […]

Key Outcomes: Daiichi initiated P3 of Datopotamab deruxtecan (Datroway) for NSCLC, Pfizer’s P3 BREAKWATER study showed promising combinations in BRAF V600E mCRC, reinforcing global ADC and targeted therapy focus Biopharma deal-making remained strong across oncology and immunology, with multiple high-value licensing and collaboration agreements Pipeline momentum was robust in neurology and rare diseases, as Eisai/Biogen […]