Merck & Co. shares fell 3.7% after Phase 3 LITESPARK‑012 trial in advanced renal cell carcinoma failed to meet primary endpoints.
The trial enrolled 1,688 patients and compared two experimental combos (Keytruda/Lenvima/Welireg and MK‑1308A/Lenvima) against Keytruda plus Lenvima control.
Bloomberg analyst said the setback cuts 2030 Welireg sales estimate by $300 million (13%) but impacts Merck less than 1% of total sales.
FDA has accepted two supplemental NDAs from the LITESPARK‑011 trial, with a target action date of October 4, 2026.