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Mediar Therapeutics has dosed the first participants in a Phase 1 trial evaluating MTX-439, a first-in-class monoclonal antibody targeting SMOC2 for fibrosis associated with chronic kidney disease. The study marks the company's third anti-fibrotic program to enter clinical development and highlights growing interest in fibrosis-directed biologics.

China's National Medical Products Administration has approved izalontamab brengitecan (iza-bren) for recurrent or metastatic nasopharyngeal carcinoma, making it the first bispecific antibody-drug conjugate to receive regulatory approval anywhere in the world.

AbbVie has entered a definitive agreement to acquire Apogee Therapeutics for $10.9 billion, adding zumilokibart, a subcutaneous half-life extended IL-13 monoclonal antibody in Phase 3 development for atopic dermatitis, asthma, and eosinophilic esophagitis.

Speaking at BIO 2026, Infinimune's Dr Wyatt McDonnell explains how the company’s human-derived antibody platform enables multi-objective optimization that AI alone and transgenic models cannot replicate.

Innovent advances a trispecific antibody into phase 3 multiple myeloma testing, Bionyra enters the crowded TL1A race in inflammatory bowel disease, and Insilico Medicine partners with SK Biopharmaceuticals to apply AI to neuroimmune and CNS drug discovery.

At BIO International Convention 2026, Dr. Sabeen Mekan of Zymeworks, Inc., discusses how advances in ADC conjugation, payload selection, and antibody engineering could improve tolerability and therapeutic index for cancer patients.

Innovent Biologics has dosed the first patient in TriadicMM-1, a pivotal phase 3 trial evaluating IBI3003, a GPRC5D/BCMA/CD3 trispecific antibody, for relapsed or refractory multiple myeloma — marking the second trispecific antibody globally to reach pivotal phase 3 development in this setting and the first with independent intellectual property rights in China.

Newly launched Bionyra Pharma has raised $165 million in Series A financing and secured exclusive global rights to two TL1A-targeting biologics from China's TrueLab Biopharmaceutical — an anti-TL1A monoclonal antibody and a TL1A×IL-23p19 bispecific antibody — in a deal worth up to $985 million, positioning the company to compete in an IBD drug class already drawing attention from Merck, Roche, and the Sanofi/Teva partnership.

The deal, announced at BIO 2026, carries total potential value exceeding $2.5 billion and will use Insilico's Pharma.AI platform to drive target-to-candidate discovery across neuroinflammatory, neurodegenerative, and rare neurological indications.

Takeda will use Boltz biomolecular AI models to support structure prediction, affinity estimation, and molecular design in preclinical research.

Japan's Ministry of Health, Labour and Welfare has approved the subcutaneous formulation of isatuximab (Sarclisa) across multiple myeloma treatment lines, making it the second country after the European Union to greenlight the administration route change backed by Phase 3 IRAKLIA trial data — with a US decision now expected by July 23, 2026.

The FDA's Vaccines and Related Biological Products Advisory Committee voted unanimously on June 18, 2026 that the benefits of mFLUSIVA (mRNA-1010) outweigh its risks for adults 50 and older, positioning Moderna for a potential approval by August 5 that would make the vaccine the first mRNA-based seasonal influenza product licensed in the US.

Today's BioPharm Brief covers an FDA filing acceptance for Roche's Lunsumio and Polivy combination in lymphoma, a pediatric expansion for Merck's CAPVAXIVE vaccine, and a key advisory committee meeting for Moderna's mRNA-based flu vaccine.