Biologic Drugs in Development

The companies’ new immunology-driven mAb, which targets an immune-evasion pathway in myeloproliferative neoplasms, is advancing toward first-in-human trials.

The company is targeting the $3 billion pancreatic cancer market with its lead proenzyme therapy candidate, PRP, which is supported by strong preclinical tumor inhibition data and for which a PK assay will be developed and validated.

Results from a head-to-head study highlight cytokine-targeting differences between UCB’s bimekizumab and risankizumab, strengthening evidence for dual IL-17 blockade in psoriatic arthritis therapy

The new clinical data show biomarker reductions and new motor milestones with salanersen, which supports once-yearly antisense therapy development in spinal muscular atrophy.

Data from the MajesTEC-9 Phase III trial shows teclistamab as monotherapy improves survival, indicating a shift in multiple myeloma treatment.

The launch of a new mRNA biotech spinout signals a structural shift in how next-generation RNA therapeutics are developed and commercialized.

In a Phase II trial, Pfizer’s tilrekimig demonstrated well-tolerated, dose-dependent improvements in chronic Th2 inflammation, supporting further clinical development in atopic dermatitis.

Phase III trial results show that trastuzumab deruxtecan reduced invasive recurrence or death 53% in patients with residual HER2-positive disease after neoadjuvant therapy.

China’s approval of Sciwind’s ecnoglutide for weight management, alongside the company’s Pfizer commercialization deal, intensifies competition in the global GLP-1 market.

Updated analysis from the COMPASSION-03 Phase II trial links response depth to survival, which supports PD-1/CTLA-4 bispecific checkpoint strategies in heavily pretreated cervical cancer.

Under the partnership, INOVIO and Akeso will evaluate DNA-encoded tumor antigen priming plus PD-1/CTLA-4 bispecific blockade in an adaptive Phase II trial for glioblastoma.

Data from Novo Nordisk’s UBT251 Phase II trial support triple-receptor metabolic modulation as a strategy to enhance weight-loss efficacy beyond single-pathway incretin therapies.

CGT Catapult’s newly formed advisory board aims to address manufacturing, data, and regulatory constraints influencing scalable development and clinical deployment of ATMPs.

Trust-based CDMO partnerships are becoming essential to accelerate injectable drug development, manage risk, and ensure resilient biopharma supply.

Roche’s termination of the SHIELD DMD trial highlights how recruitment and regulatory feasibility increasingly shape rare disease drug development.

Long-term data from a Johnson & Johnson study show that sustained IL-23 inhibition maintains histologic and endoscopic remission, supporting durability-driven UC drug development strategies.

Bristol Myers Squibb’s luspatercept-aamt data validate erythroid maturation targeting, supporting scalable development strategies for genetic anemia therapeutics.

FDA’s priority review designation of Regeneron Pharmaceuticals’ garetosmab underscores Activin A inhibition as a potential disease-modifying strategy for genetically driven ossification disorders.

Lilly’s Phase IIIb trial shows improved psoriasis disease control using an integrated immune and metabolic pathway modulation approach, supporting biologically informed combination strategies in inflammatory disorders.

FDA’s breakthrough therapy designation for Johnson & Johnson’s co-formulated bispecific antibody therapy validates dual EGFR/MET targeting in HPV-negative head and neck cancer.

Phase III data showed sustained IL-5 suppression with 48–58% exacerbation reduction and significant CRSwNP score improvements across 52 weeks.

FDA’s IND clearance advances CStone’s trispecific antibody into Phase II development, expanding multispecific immunotherapy in solid tumors.

Under an exclusive license, the joint venture aims to advance HCW11-006 into Phase I for solid tumors, validating TRBC-derived immunotherapy in a global development strategy.

A preclinical 21-day minipig study found that a hyaluronidase-free, nanoformed subcutaneous formulation of trastuzumab achieved pharmacokinetic exposure comparable to Herceptin HYLECTA, with favorable tolerability, supporting further investigation of nanoparticle-based delivery approaches for monoclonal antibodies.

Stoke has initiated a Phase I trial of STK-002, advancing antisense protein restoration as a potential strategy for genetic optic neuropathies.