Merck nabs mid-stage trial win for skin disease drug (MRK:NYSE)

Daiichi Sankyo and Merck withdrew the BLA for I-DXd in ES-SCLC after FDA discussions. The phase 2 trial data did not meet accelerated approval requirements. The phase 3 trial is ongoing. I-DXd is an investigational B7-H3-directed ADC. The FDA previously granted priority review for this indication.

Merck reported positive Phase 2b trial results for its anti-TL1A antibody tulisokibart in treating hidradenitis suppurativa, with 72% and 64% of high and medium dose patients achieving at least 50% reduction in skin lesions, respectively. Analysts at Guggenheim and BMO Capital Markets viewed the data as compelling and potentially competitive with existing treatments. The trial included 149 patients.

Merck (MRK) reported that its phase IIb study of tulisokibart for hidradenitis suppurativa met primary endpoints, with high and medium doses showing superiority over placebo. The drug demonstrated improvements in clinical response and quality of life. Merck plans to advance tulisokibart into phase III development and is evaluating it in other immune-mediated diseases.

Moderna (MRNA) and Merck (MRK) reported that their cancer vaccine reduced melanoma recurrence in a study, according to the companies. Experts called the results a 'landmark win' with potential for significant sales. The companies plan further steps, which could impact their stock prices.

Merck (NYSE:MRK) reported positive Phase 2b trial results for tulisokibart, an investigational treatment for hidradenitis suppurativa. The study met its primary endpoint, with high and medium doses showing 37% and 29% improvements over placebo. Secondary endpoints and quality of life measures also improved. The therapy demonstrated a safety profile comparable to placebo. Merck shares were down 1.63% to $146.85 at the time of publication.

Merck's Remigromig met the primary endpoint in the Phase 2b/3 BRUNELLO trial for diabetic macular edema (DME), according to Eyewire+. The trial results indicate potential efficacy of the drug in treating DME, which may impact Merck's position in the ophthalmology market.