Gilead Trodelvy First-Line TNBC Approval
The FDA approved Trodelvy for first-line metastatic triple-negative breast cancer, significantly expanding Gilead’s commercial opportunity and reinforcing TROP2-directed ADCs as a leading oncology modality.
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Zynlonta Safety Concerns Raise Regulatory Risk
ADC Therapeutics announced a strategic reorganization that will reduce its workforce by approximately 17%, with resources redirected toward Zynlonta growth opportunities and regulatory priorities. The move follows safety concerns in LOTIS-5 and represents a…
World First CAR-T Therapy for Solid Tumors
China’s NMPA approved CARsgen’s satri-cel, the first CAR-T therapy approved anywhere in the world for a solid tumor.
Be Bio Terminates BE-101 Hemophilia B Program
Be Biopharma terminated the Phase 1/2 BeCoMe-9 study of BE-101, the first engineered B cell medicine tested clinically in hemophilia B.
China BTK Challenger Enters Western Markets
InnoCare presented more than 40 orelabrutinib studies at EHA 2026, including the first treatment-naive CLL/SLL clinical data from US and European patients.
Intellia Therapeutics Lonvo-z Phase 3
Intellia reported additional positive Phase 3 data for lonvoguran ziclumeran (lonvo-z) in hereditary angioedema, reinforcing earlier primary endpoint success and strengthening the regulatory profile of one of the most advanced in vivo CRISPR programs…
Real-World Validation of Menin Inhibition in Acute Leukemia
Syndax presented interim real-world evidence from the ROAR study at EHA 2026 showing an 82% overall response rate and 64% CR/CRh rate among heavily pretreated patients with relapsed or refractory NPM1-mutated or KMT2A-rearranged acute…
Rare Hematology Portfolio Real-World Evidence Update
Sobi presented new clinical and real-world evidence across four rare hematology franchises at EHA 2026: PNH (pegcetacoplan), ITP (avatrombopag), HLH (emapalumab), and myelofibrosis (pacritinib). While no pivotal efficacy readouts were disclosed, the package reinforces…
First Potential FDA-Approved Therapy for wAIHA
Johnson & Johnson presented pivotal ENERGY Phase 2/3 data showing statistically significant durable hemoglobin responses for IMAAVY in warm autoimmune hemolytic anemia, supporting its February 2026 sBLA filing.
Climb Bio Budoprutug Phase 1b, First Anti-CD19 Antibody in ITP
Climb Bio presented the first clinical data for budoprutug, an anti-CD19 monoclonal antibody, in primary immune thrombocytopenia (ITP). Early Phase 1b results demonstrated robust B-cell depletion, encouraging safety, and meaningful platelet responses in heavily…
