Biologic Drugs in Development

The FDA has accepted Sarepta's supplemental New Drug Applications seeking to convert casimersen (Amondys 45) and golodirsen (Vyondys 53) from accelerated to traditional approval in Duchenne muscular dystrophy, with a PDUFA target action date of February 28, 2027, backed by ESSENCE confirmatory trial data and years of real-world evidence.

The FDA has granted priority review to Genentech's sBLA for Enspryng (satralizumab), an IL-6 receptor-targeting monoclonal antibody, as a potential first at-home subcutaneous treatment for thyroid eye disease, based on Phase III SatraGO data showing significant proptosis reduction, with an FDA decision expected by October 15, 2026.

ADC Therapeutics has completed enrollment of 100 patients in the Phase 1b LOTIS-7 trial evaluating loncastuximab tesirine-lpyl plus the bispecific antibody glofitamab in relapsed/refractory diffuse large B-cell lymphoma, with full data expected in Q4 2026 following earlier results showing an 89.8% overall response rate.

From his presentation at BIO 2026, Infinimune CEO Dr Wyatt McDonnell makes the case for how human-derived antibodies and human-trained AI models eliminate species translation failure and compress time to IND.

52-abstract package includes first reported real-world at-home subcutaneous administration data and phase 2 combination findings with anti-tau antibody.

Dr Wyatt McDonnell, Infinimune CEO, details how FDA's non-animal model guidances are reshaping non-clinical safety strategies for mAb developers in his talk at BIO 2026.

New York-based biotech enters Nasdaq through JATT II merger, betting IL-13 × IL-18 dual blockade can break the efficacy ceiling in I&I

Lumvoa gains FDA approval for thyroid eye disease, adding an IGF-1R antagonist supported by phase 3 active and chronic TED trials.

Industry experts from Sanofi, GxP Frame, and Open Biopharma outline how AI is transforming drug discovery, manufacturing, and workforce strategy through biopharma partnerships in the latest episode of Drug Digest.

As the biologic pipeline diversifies across ADCs, bispecific antibodies, and fusion proteins, formulation science has become the critical discipline bridging molecular complexity and patient-ready therapy.

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.

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.

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.

Basel’s innovation campus is expanding with new research institutes, laboratories, and collaborative infrastructure for life sciences growth.

The FDA has accepted Roche's supplemental BLA for a chemotherapy-free combination of mosunetuzumab (Lunsumio VELO) and polatuzumab vedotin (Polivy) in adults with relapsed or refractory large B-cell lymphoma, based on Phase 3 SUNMO trial data showing a 59% reduction in the risk of disease progression or death compared to standard salvage chemotherapy.

The supplemental approval is based on immunogenicity data from the STRIDE-13 phase 3 trial and, according to Merck, makes the vaccine the only one of its type specifically indicated for this at-risk pediatric population in the United States.

Moderna's mFLUSIVA (mRNA-1010) faces an FDA advisory committee vote on June 18 — a pivotal step for the first mRNA-based seasonal influenza vaccine to seek US licensure, following a turbulent regulatory path that began with an unprecedented refusal-to-file decision earlier this year.

The launch window isn't just getting shorter, it’s moving earlier. Here’s how emerging biopharma companies can prepare for commercialization before approval arrives.

The company reported that phase I data show approximately 40% of patients remained cancer-free at 10 years, while 2 phase 2 trials are ongoing.

LG AI Research and D&D Pharmatech have launched a collaboration aimed at developing next-generation oral peptide therapeutics by combining artificial intelligence-driven molecular design with peptide formulation and development expertise.