Development

Ahead of a July 29 FDA advisory committee meeting, the FDA released briefing documents disputing Capricor Therapeutics' claim that its Phase 3 HOPE-3 trial of deramiocel, a cell therapy for Duchenne muscular dystrophy cardiomyopathy, met its primary and secondary efficacy endpoints, a disagreement centered on which version of the trial's statistical analysis plan should govern the results.

AbelZeta has received FDA RMAT clearance for a registrational phase 2 trial of its bispecific CAR-T therapy, C-CAR168, in refractory lupus nephritis.

GSK will invest £400 million (US$532 million) in a new Cambridge, UK, R&D center, relocating from Stevenage amid second quarter earnings and a cost-savings plan.

Veraxa Biotech has advanced its bispecific antibody-drug conjugate program VXA-222 into its next development phase after OmniAb completed discovery work under their May 2025 collaboration, creating a dual-antigen "AND-gate" candidate designed to improve precision in solid tumor treatment.

Harbour BioMed and Sinopharm have formed a strategic Innovation Consortium to co-develop biologics in oncology and immune-mediated inflammatory disease.

argenx will acquire Forte Biosciences for $2.2 billion, which will add first-in-class anti-CD122 antibody, FB102, to its immunology pipeline.

Johnson & Johnson reported that phase 3 MonumenTAL-6 data show Tecvayli plus Talvey cut the risk of progression or death by 89% in relapsed/refractory multiple myeloma.

A Phase 1 trial of DYP688, a first-in-class antibody-drug conjugate targeting the Gq/11 pathway, showed disease control in more than 80% of patients with metastatic uveal melanoma and was well tolerated, according to findings published in Nature Medicine, even after Novartis halted the drug's development.

A new peer-reviewed publication in Clinical Cancer Research details preclinical data for Pheast Therapeutics' PHST001, an anti-CD24 monoclonal antibody, showing anti-tumor activity across six solid tumor types and enhanced effects when combined with chemotherapy, radiotherapy, and antibody-drug conjugates.

Sanofi announced it has discontinued amlitelimab in atopic dermatitis, forgoing global regulatory submissions despite positive long-term phase 3 data.

Repligen will acquire BioLife Solutions for $1.5 billion, adding CryoStor biopreservation media to its cell therapy portfolio.

HCW Biologics has requested an FDA meeting for HCW11-018b, its tetravalent T-cell engager for solid tumors, targeting trials in the first half o 2027.

The European Medicines Agency has granted orphan designation to Atsena Therapeutics' ATSN-101 and ATSN-201, AAV gene therapies for Leber congenital amaurosis 1 and X-linked retinoschisis, as both programs advance toward pivotal Phase 3 trials.

Ipsen has completed its acquisition of Memo Therapeutics, which adds potravitug, an anti-BKPyV antibody, to its rare disease pipeline.

Phase 3 SHASTA-3/4 trials show plozasiran cut triglycerides up to 81% and reduced pancreatitis events up to 100% in high-risk sHTG patients.

Greenwich LifeSciences has received UK regulatory approval to expand its Phase III FLAMINGO-01 trial of GLSI-100, a HER2-derived peptide cancer vaccine designed to prevent breast cancer recurrence, adding up to 10 new UK sites through a collaboration with The Royal Marsden.

Propanc Biopharma has reported peer-reviewed data on scalable recombinant production of trypsinogen and chymotrypsinogen, supporting a synthetic backup to its lead cancer candidate, PRP.

Imunon has reported positive preliminary data from its phase 2 minimal residual disease study of IMNN-001, a DNA-based IL-12 gene immunotherapy, showing a lower MRD-positive rate, higher ctDNA clearance, and more patients reaching no evidence of disease compared to standard chemotherapy alone in frontline advanced ovarian cancer.

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Under the deal, Lonza will grant Engitix a single-target ADC license for SYNtecan E, GlycoConnect, and HydraSpace to advance ECM-targeted fibrosis and cancer therapies.

MilliporeSigma's Sebastián Arana outlines why flexible, platform-based manufacturing and workforce training are now table stakes for competitive biomanufacturers.

Scholar Rock’s apitegromab is awaiting a US manufacturing facility resolution, which may impact the therapy’s European review, for which clinical assessment has been completed.

Halozyme and Incyte will advance subcutaneous INCA033989 for mutCALR-positive MPNs, with the aim of improving treatment delivery while supporting targeted clinical development.

The EC has approved AbbVie's Boey (trenibotulinumtoxinE), the first serotype E neurotoxin for glabellar lines, with faster onset than current options.

A phase 1 trial of mKRAS-VAX, an off-the-shelf synthetic peptide vaccine targeting mutant KRAS, safely stimulated durable, tumor-specific T-cell responses in 90% of high-risk individuals, with none of the 20 participants developing pancreatic cancer after a median follow-up of 16.5 months.