UCB reported Week 16 data from the Phase 3 BE BOLD study showing Bimzelx outperformed risankizumab on the primary ACR50 endpoint in psoriatic arthritis, marking the first approved biologic to demonstrate superiority in joint outcomes in a head-to-head PsA trial.
Cell therapy developers are prioritizing scalable manufacturing strategies alongside efficacy to support broader commercial deployment, notes Cellular Origins CEO Dr. Edwin Stone at the 2026 ASGCT Annual Meeting.
Preclinical ASGCT 2026 data suggest JCR Pharmaceuticals’ JUST-AAV platform may improve central nervous system delivery while reducing liver exposure in AAV-based gene therapies for rare neurodegenerative diseases.
Hansa Biopharma’s licensing agreement with SERB will support expanded commercialization of imlifidase (Idefirix) for highly sensitized kidney transplant patients across Europe and MENA.
Incyte and Edison Scientific have entered a strategic collaboration to integrate the Kosmos AI platform across Incyte’s research and development operations, reflecting the growing role of continuous-learning AI systems in biopharmaceutical drug discovery and translational medicine.
Regeneron’s new partnership with Parabilis Medicines underscores growing industry interest in next-generation conjugate technologies designed to reach historically “undruggable” intracellular targets through peptide-enabled delivery systems.
FDA approvals for Enhertu in both neoadjuvant and adjuvant HER2-positive early breast cancer settings mark a major expansion of antibody-drug conjugates into curative-intent treatment, supported by pivotal Phase 3 DESTINY-Breast11 and DESTINY-Breast05 data.
FDA’s approval of Immgolis and Immgolis Intri introduces the first golimumab biosimilars for rheumatoid arthritis and ulcerative colitis in the United States.
Exploratory analyses from the Phase 3 POTOMAC trial showed AstraZeneca’s Imfinzi plus BCG regimen reduced early high-risk recurrences and delayed cystectomy in patients with high-risk non-muscle-invasive bladder cancer.
New Phase 1/2 findings presented at ASGCT 2026 suggest Imviva Biotech’s investigational allogeneic CAR-T therapy CTA313 may induce durable remission and immunosuppression-free disease control in systemic lupus erythematosus.
Biogen has completed its acquisition of Apellis Pharmaceuticals, adding complement-targeting therapies Empaveli and Syfovre to its portfolio and strengthening the company’s position in nephrology and rare disease therapeutics.
REGENXBIO announced positive topline Phase 3 AFFINITY DUCHENNE trial results showing that investigational gene therapy RGX-202 achieved significant microdystrophin expression and demonstrated a correlation with functional improvement in patients with Duchenne muscular dystrophy.
Through a Series B financing, CREATE Medicines will support clinical advancement of its in vivo CAR-T candidates for autoimmune disease and oncology indications.
AstraZeneca reported that the Phase 3 VOLGA trial demonstrated statistically significant improvements in event-free survival and overall survival with perioperative durvalumab plus neoadjuvant enfortumab vedotin in cisplatin-ineligible patients with muscle-invasive bladder cancer.
Certara UK’s Dr. Armin Sepp, who spoke at the 2026 AAPS National Biotechnology Conference, explains how quantitative systems pharmacology may improve CAR T-cell safety and efficacy by modeling immune activation, tumor response, and cell persistence.
New analyses from Novo Nordisk’s Phase 3 OASIS 4 trial showed that adults taking oral Wegovy achieved substantial weight loss and improved physical mobility, reinforcing the potential of oral semaglutide in obesity management.
AstraZeneca reported positive Phase 3 CALYPSO data showing eneboparatide normalized serum calcium and reduced dependence on conventional supplements in adults with chronic hypoparathyroidism, supporting continued development of the investigational PTH receptor agonist.
Abzena’s Dr. Jeffrey C. Mocny and Cellares’ Anna McMahon discuss how biopharmaceutical risk-based standards accelerate innovation and speed-to-market by leveraging data for better patient outcomes and safety.
AskBio has dosed the first participant in a Phase 1/2 clinical trial evaluating AB-1009, an investigational AAV-based gene therapy for late-onset Pompe disease.
Servier received FDA Breakthrough Therapy designation for emiltatug ledadotin, a B7-H4-targeting antibody-drug conjugate being developed for patients with advanced adenoid cystic carcinoma.
The approval of zenocutuzumab-zbco for NRG1 fusion-positive cholangiocarcinoma expands precision oncology options for patients with rare molecularly defined cancers.
Zai Lab received FDA Fast Track designation for zocilurtatug pelitecan, a DLL3-targeting antibody-drug conjugate, advancing development of a potential new treatment option for extrapulmonary neuroendocrine carcinomas.
argenx secured expanded FDA approval for efgartigimod alfa-fcab and efgartigimod alfa and hyaluronidase-qvfc broadening access to all adult patients with generalized myasthenia gravis regardless of antibody status.
Harbour BioMed has received FDA IND clearance to begin a Phase I trial of its B7H4xCD3 bispecific antibody HBM7004 for advanced solid tumors, advancing its pipeline of T cell–engaging cancer immunotherapies.
Johnson & Johnson reported Phase 2b results for its investigational dual-pathway co-antibody JNJ-4804, showing improved clinical remission and endoscopic outcomes in patients with refractory inflammatory bowel disease.
