Emily Schoenthaler

Merck’s Enflonsia (clesrovimab) has been approved by the European Commission for RSV prevention in infants. The long-acting monoclonal antibody is given as a single fixed dose and is supported by Phase 2b/3 and Phase 3 data showing reduced RSV hospitalizations.

Marengo Therapeutics reported early Phase 2 activity for its invikafusp alfa combination in metastatic breast cancer and highlighted progress across its Selective T Cell Activation Repertoire (STAR) platform at the 2026 American Association for Cancer Research (AACR) Annual Meeting.

A look inside our latest issue of BioPharm International, where we explore how the biopharma industry is leaning into technical innovation while remaining grounded in operational discipline.

Roche plans a Phase III study of Elevidys to generate additional data for European approval and expand access for patients with Duchenne muscular dystrophy. The trial will evaluate efficacy and safety in ambulatory boys, aiming to strengthen clinical evidence and enable broader approval and reimbursement.

Eli Lilly and Company reported that its oral GLP-1 therapy orforglipron met the primary cardiovascular safety endpoint in a Phase 3 trial, while also delivering superior A1C reduction and weight loss compared with insulin glargine. The drug additionally showed a substantial reduction in all-cause mortality in a pre-planned analysis, supporting plans for FDA submission in type 2 diabetes.

PrecisionLife and Ovation.io are partnering to translate multi-omic analyses of GLP-1 receptor agonist use into predictive biomarker tools, with early findings indicating distinct biological drivers of glycemic control and weight loss and supporting development of diagnostic tests to guide treatment selection and clinical trial stratification.

Updated Phase 1/2 data show trastuzumab pamirtecan achieved an objective response rate of around 50% and disease control exceeding 90% in heavily pretreated patients with HER2-expressing recurrent endometrial cancer, with responses observed across varying levels of HER2 expression and duration of response not yet reached.

Mirvetuximab soravtansine–carboplatin combination demonstrates strong response rates and manageable safety profile in FRα-positive patients.

Ifinatamab Deruxtecan is a potential first-in-class B7-H3–directed antibody-drug conjugate for this patient population, which currently faces limited treatment options and poor prognosis.

Oricell Therapeutics has raised over $110 million in a pre-IPO round to advance its CAR-T cell therapy platform aimed at treating solid tumors, including liver cancer. The company is developing its lead candidate Ori-C101 and next-generation CAR-T technologies such as in vivo and armored CAR-T, positioning itself to address longstanding challenges in solid tumor immunotherapy.

Alpheus Medical has initiated a phase 2b trial evaluating a novel sonodynamic therapy approach for glioblastoma, with early patient enrollment underway. The investigational PoMA platform aims to improve outcomes by targeting diffuse tumor cells across the brain, addressing a major limitation of current treatments.

Astellas taps Dyno’s AI-designed AAV capsid to boost skeletal muscle gene delivery, aiming for lower doses and safer next-gen therapies.

Phase 2 results from Sanofi suggest that lunsekimig could emerge as a novel treatment option for respiratory conditions such as asthma and chronic rhinosinusitis with nasal polyps. The investigational therapy achieved both primary and key secondary goals in two clinical studies, supporting its potential as a dual-target biologic aimed at tackling complex inflammatory pathways.

Subcutaneous Tepezza shows Phase 3 efficacy in thyroid eye disease, achieving 77% response, significant proptosis reduction, and improved patient outcomes.