Development

Merck has dosed the first patient in the Phase 3 PROCEDE-CRC-03 trial evaluating investigational antibody-drug conjugate precemtabart tocentecan in metastatic colorectal cancer. The CEACAM5-targeted ADC is being studied against standard chemotherapy in previously treated patients, highlighting growing industry momentum around targeted oncology therapies and next-generation antibody-drug conjugates.

Eli Lilly’s investigational obesity drug retatrutide produced up to 28.3% average weight loss in the Phase 3 TRIUMPH-1 study, strengthening momentum behind next-generation triple agonist therapies.

Life science organizations that will lead the next decade ar those that deploy systems that are scientifically credible, clinically defensible, regulatorily traceable, and operationally sustained.

Avaí Bio and Austrianova have completed a GMP master cell bank for an early-stage α-Klotho cell therapy program.

Dr. Edwin Stone, CEO of Cellular Origins, emphasizes that scalable manufacturing must support, not limit, development of safe and effective biological therapies like cell therapies while speaking at the 2026 ASGCT Annual Meeting.

Novo Nordisk presented new EASL 2026 data highlighting semaglutide’s liver safety profile and subgroup efficacy in metabolic dysfunction-associated steatohepatitis, reinforcing the growing role of GLP-1 therapies in chronic liver disease management.

Updated RestorAATion-2 data show durable M-AAT restoration and Z-AAT reduction across biweekly and monthly dosing regimens, with FDA accelerated approval pathway feedback anticipated mid-2026

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.

Erik Wiklund discusses how circular RNA-based AAV expression systems may improve gene therapy durability, reduce toxicity, and lower dosing requirements for next-generation therapies.

Vibha Jawa, PhD, discussed evolving approaches to preclinical development, animal use reduction, and immunogenicity assessment during an interview with BioPharm International at AAPS NBC 2026.

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.

Webinar Date/Time: Fri, Jun 19, 2026 11:00 AM EDT

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.

For ATMP developers, the greatest barrier to commercialization is often not scientific discovery or funding, but the challenge of translating research-stage processes into reproducible, GMP-compliant manufacturing without compromising the therapy itself.

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.