Merck’s remigromig meets non-inferiority goal in DME trial

Merck (MRK) reported one-year results from its BRUNELLO trial for remigromig, an investigational drug for diabetic macular edema (DME). Both doses met the primary endpoint, showing non-inferiority to ranibizumab in visual acuity improvement. However, adverse events related to proliferative diabetic retinopathy were more frequent with remigromig. Merck plans to discuss results with regulators and is conducting further analyses.

Merck (MRK) presented one-year results from the BRUNELLO trial of remigromig for diabetic macular edema, showing non-inferiority to ranibizumab but no superiority. Both doses met primary endpoints, with mean BCVA gains of +9.1 and +8.7 letters vs. +11.8 for ranibizumab. Adverse events were more frequent with remigromig.

Merck's experimental eye drug, remigromig, met its primary endpoint in a Phase 2b/3 trial for diabetic macular edema (DME), showing non-inferior visual acuity compared to ranibizumab. However, it had a higher rate of adverse events related to proliferative diabetic retinopathy. The company plans to discuss the results with regulators and continue evaluating the drug in ongoing studies.

Merck Animal Health, a division of Merck & Co. (MRK), announced peer-reviewed studies on gilvetmab, an anti-PD-1 monoclonal antibody for canine cancer treatment. The studies showed efficacy in melanoma and mast cell tumors, with a 66.7% clinical benefit rate. Gilvetmab is conditionally approved by the USDA and available in the U.S. The company plans further studies to support its safety and efficacy.

A new NIH initiative to accelerate personalized cancer vaccine development has sparked a rally in biotech stocks. Moderna, Novavax, BioNTech, Pfizer, Merck, and Vaxcyte saw gains. The program, launching in December, focuses on pancreatic, liver, colorectal cancers, and childhood tumors. Moderna and Merck reported positive Phase 3 results for their mRNA cancer vaccine in August. BioNTech is advancing multiple cancer therapies.

A Dutch court barred Merck from manufacturing and marketing its under-the-skin version of Keytruda in eight European countries, ruling it infringes Halozyme's drug-delivery patent. The decision follows EU top court guidance on cross-border injunctions involving foreign patent rights.