Biologic Drugs in Development

TreeFrog Therapeutics reports that TFG-001 preclinical data suggest early dopamine release and graft-derived reinnervation in Parkinson disease models.

Subcutaneous infliximab may help improve treatment convenience, dosing consistency, and long-term adherence for patients with inflammatory bowel disease, according to discussions at DDW 2026. Clinicians highlighted the potential for self-administered infliximab to support sustained remission while reducing infusion-center burden and improving patient-centered care.

Kelun-Biotech reported positive Phase 3 results for sacituzumab tirumotecan in first-line metastatic triple-negative breast cancer, demonstrating a statistically significant improvement in progression-free survival versus chemotherapy. The findings further strengthen momentum behind TROP2-directed antibody-drug conjugates in oncology and highlight growing competition in the metastatic breast cancer treatment landscape.

The Phase 3 CANOPY-HCH-3 data show statistically significant gains in annualized growth velocity, standing height, and arm span at 52 weeks; regulatory filings planned for Q3 2026.

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.

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.

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.