Sanofi SA will not seek approval of amlitelimab in atopic dermatitis (AD) as previously planned, stating that the OX40-ligand monoclonal antibody “would not represent a meaningful improvement to the standard of care” for patients with moderate to severe disease. The company said the decision, which marks an about-face as Sanofi had been looking to amlitelimab as a possible successor to its Regeneron Pharmaceuticals Inc.-partnered blockbuster AD drug Dupixent (dupilumab), comes as part of an ongoing assessment of the pipeline.

Mentari Therapeutics Inc. has announced a $200 million private placement to support continued development of its pipeline of targeted biologics for migraine.

Wall Street is sifting data to figure out what Celldex Inc.’s phase II failure with KIT inhibitor barzolvolimab (barzo) in prurigo nodularis (PN) might mean for the upcoming phase III readout with the same drug in chronic spontaneous urticaria (CSU).

Another day, another two multibillion-dollar deals with Asian companies, this time involving Dizal Pharmaceutical Co. Ltd. and its EGFR inhibitor for lung cancer, as well as Innovent Biologics Inc. and its anti-CD40L antibody for a chronic fibroinflammatory condition.

Another day, another two multibillion-dollar deals with Asian companies, this time involving Dizal Pharmaceutical Co. Ltd. and its EGFR inhibitor for lung cancer, as well as Innovent Biologics Inc. and its anti-CD40L antibody for a chronic fibroinflammatory condition.

Trex Bio Inc. has disclosed that its development candidate TRB-071, currently in IND-enabling studies, is a CD30 agonist antibody. The approach could have therapeutic potential in inflammatory bowel disease and other autoimmune and inflammatory diseases.

Samsung Bioepis Co. Ltd. announced positive top-line phase I and phase III data for SB-27, a proposed biosimilar to Merck & Co. Inc.’s blockbuster immunotherapy Keytruda (pembrolizumab). Preliminary analysis of parallel-run global phase I and phase III studies demonstrated SB-27’s clinical and pharmacokinetic (PK) equivalence to the reference product, according to a company announcement.

Samsung Bioepis Co. Ltd. announced positive top-line phase I and phase III data for SB-27, a proposed biosimilar to Merck & Co. Inc.’s blockbuster immunotherapy Keytruda (pembrolizumab). Preliminary analysis of parallel-run global phase I and phase III studies demonstrated SB-27’s clinical and pharmacokinetic (PK) equivalence to the reference product, according to a company announcement.

Graves’ disease is a form of autoimmune hyperthyroidism where the main extrathyroidal feature is thyroid eye disease. Autoantibodies that stimulate thyroid-stimulating hormone receptor (TSHR) are released and orchestrate hormone production in the thyroid tissue and the orbit. Regeneron Pharmaceuticals Inc. has developed REGN-24493, a monoclonal antibody (MAb) that binds TSHR and blocks its activation by those autoantibodies.