Merck's Remigromig Meets Key Goal In Phase 2b/3 BRUNELLO Study In Diabetic Macular Edema

FDA approved Merck's Welireg (belzutifan) plus Eisai's Lenvima (lenvatinib) for advanced renal cell carcinoma patients who progressed after PD-1/PD-L1 therapy. The approval is based on the Litespark-011 trial showing a 26% reduction in disease progression risk vs. cabozantinib. Lenvima is already approved for first-line advanced RCC, while Welireg is approved as monotherapy and in combination with Keytruda.

Merck (MRK) and Eisai announced FDA approval for WELIREG (belzutifan) plus LENVIMA (lenvatinib) to treat advanced kidney cancer. The combo reduced disease progression/death risk by 26% in a trial, but no significant overall survival benefit was seen. Serious side effects occurred in 54% of patients.

Merck and Moderna's mRNA cancer vaccine, intismeran autogene, showed positive results in a late-stage trial, extending survival time without cancer recurrence or spread. The vaccine, tested on melanoma patients, trains the immune system to target cancer cells. Full results will be presented at the 2026 European Society for Medical Oncology meeting. The trial involved 1,137 participants, with two-thirds receiving the vaccine alongside Keytruda, a standard immunotherapy.

Bank of America (BAC) hosted investor meetings with Merck's (MRK) Chief Medical Officer, expressing confidence in Merck's pipeline. Keytruda, Merck's top-selling drug, faces patent expiration in 2028. Merck raised its 2026 revenue forecast to $66.3B-$67.3B. BofA maintained a Buy rating and $166 price target. Merck's sac-TMT lung cancer drug is a key focus, with trial results expected in October.

Merck (MRK) reported positive Phase 2b/3 trial results for its investigational antibody remigromig in treating diabetic macular edema, matching a standard treatment. The success could expand Merck's revenue mix into ophthalmology. Analysts note this fits Merck's strategy to diversify beyond oncology, but near-term catalysts remain in other areas. Merck projects US$75.1b revenue and US$22.4b earnings by 2029, with some analysts forecasting higher figures.

Merck (MRK) received an FDA label update for WINREVAIR in pulmonary arterial hypertension, including Phase 3 trial data. The stock has seen significant gains, with a 1-year total shareholder return of 91.32%. Merck's pipeline expansion and strategic moves aim to drive long-term earnings, though risks include Keytruda exclusivity loss and pricing pressures. The stock trades at $148.08, near its fair value estimate of $150.42, with a high P/E ratio of 115.1x.