A regimen combining two of Johnson & Johnson's bispecific antibodies has delivered deep and sustained PSA responses in patients with advanced prostate cancer, whilst also demonstrating an encouraging safety profile. The findings, representing the first-in-human results for the pairing, were presented at the Society for Immunotherapy of Cancer (SITC) annual meeting. The regimen combines the KLK2/CD3 bispecific antibody pasritamig and the PSMA/CD28 costimulatory bispecific antibody JNJ-9401. J&J

More than 50,000 doses of SKY-0515 have now been administered to patients. Nov. 5, 2026 -- Skyhawk Therapeutics, Inc., a clinical-stage biotechnology company developing novel small molecule therapies designed to modulate RNA targets, today announced that the first U.S. patients have been dosed in the global pivotal FALCON-HD study evaluating SKY-0515 in Huntington's disease (HD). Dosing in the U.S. began at the CenExel Movement Disorder Center in Colorado. Additional U.S. sites, including Beth

First clinical trial combining a Vβ-directed selective T-cell agonist with an ADC supports invikafusp alfa’s potential as a precision immune amplifier and IO backbone for broader cancer patient populations Encouraging clinical activity observed across two different metastatic breast cancer populations including HR-positive/HER2-negative metastatic breast cancer, where most patients derive limited benefit from checkpoint inhibition, and metastatic TNBC Maturing results demonstrate reductions in t

Nov. 08, 2026 -- InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, announced today that the first patient has been dosed in registrational Phase III study of the Company's novel BCL2 inhibitor mesutoclax (ICP-248) in combination with azacitidine versus venetoclax with azacitidine in elderly or unfit patients with treatment naive (TN) acute myeloid leukemia (AML). Mesutoclax is a novel, oral BCL2 inhibitor

Data presented at AASLD The Liver Meeting demonstrated 100% of participants (28/28) who completed Week 96 of combination therapy reached undetectable virus (as defined by HDV RNA TND) Separate, exploratory analysis suggests curative potential with 10/10 patients who discontinued treatment after at least 96 weeks of undetectable virus showing sustained viral response (SVR) after 12 to 48 weeks of follow-up Conference call to discuss topline ECLIPSE 1 results and expanded SOLSTICE data scheduled f

In myositis, 5/6 (83%) patients treated at 4 billion cells per dose with at least three months of follow-up achieved moderate or major responses, as measured by the Total Improvement Score (TIS) in the Ntrust-2 study of NKX019, an investigational, allogeneic CAR NK cell therapy. In systemic sclerosis, 6/7 (86%) patients treated at 4 billion cells per dose with at least three months of follow-up achieved a revised Composite Response Index in Systemic Sclerosis (rCRISS)-25 response or greater, wit

FDA assigns a PDUFA target action date of April 9, 2027 Combination achieved a median overall survival of 23.8 months in patients with unresectable or metastatic HCC, compared to sorafenib’s mOS of 15.2 months Nov. 05, 2026 -- Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Co., Ltd. and a fully integrated biopharmaceutical company dedicated to elevating treatment experiences and outcomes for patients with cancer, today announced the U.S. Food and Drug Administration (FDA) acknowl

Jyseleca® (filgotinib) has received expanded approval for the treatment of patients with active axial spondylarthritis (axSpA), both non-radiographic and radiographic forms of the disease, who have not responded adequately to conventional therapy. EC approval follows a positive opinion from the CHMP in September 2026 and offers a new treatment option for people living with inadequately controlled axSpA in Europe. An application has been submitted to the MHRA for UK approval and is under review.

CLD-423 Phase 1a Single- and Multiple-Dose Data Demonstrate Favorable Tolerability and Immunogenicity Profiles and Sustained Target Engagement, Supporting Planned Phase 2 Trials in Ulcerative Colitis and Crohn’s Disease in Early 2027 Exclusive Worldwide License for IL-17 x TL1A Bispecific Antibody Program Expands Pipeline of Novel Investigational Therapies for Immune-Mediated Diseases Caldera Therapeutics, Inc. (Caldera), a privately held clinical-stage biotechnology company developing bispecif

— Selective SIK2 inhibitors reduced disease activity in a mouse model of rheumatoid arthritis to levels comparable to approved therapies etanercept and upadacitinib — November 5, 2026 — Nimbus Therapeutics, LLC (“Nimbus Therapeutics” or “Nimbus”), a computational drug discovery company developing breakthrough small molecule medicines through advanced structure-based design and AI-enabled chemistry, today announced that it will present new preclinical data from its highly selective salt-inducibl