TERN-701 - (CARDINAL)

April 30, 2026: Merck & Co., Inc. first-quarter 2026 sales/earnings presentation highlighted multiple pipeline/regulatory catalysts and upcoming decision dates. Key regulatory milestones included FDA acceptance of four oncology filings, including a new BLA for ifinatamab deruxtecan (I‑DXd; with Daiichi Sankyo) with priority review in SCLC; and FDA approval of once-daily IDVYNSO (doravirine + islatravir) for certain virologically suppressed adults with HIV‑1. Merck also noted FDA approval of NUMELVI for allergic dermatitis in dogs.

Oncology: KEYNOTE‑B96 led to FDA and EC approval of KEYTRUDA + paclitaxel (± bevacizumab) for PD‑L1+ cisplatin‑resistant ovarian cancer. KEYNOTE‑B151 showed perioperative KEYTRUDA + enfortumab vedotin reduced EFS events by 47% and risk of death by 35% vs neoadjuvant chemotherapy in cisplatin‑eligible MIBC. WELIREG: LITESPARK‑022 (WELIREG+KEYTRUDA) reduced risk of recurrence/death by 28% vs KEYTRUDA alone in adjuvant RCC; LITESPARK‑011 (WELIREG+Lenvima) reduced risk of progression/death by 30% vs cabozantinib in previously treated advanced RCC.

Upcoming FDA dates: LITESPARK‑022 PDUFA June 19, 2026; KEYNOTE‑B152 PDUFA Aug 17, 2026; LITESPARK‑011 PDUFA Oct 4, 2026; I‑DXd (IDeate‑Lung01/IDeate‑PanTumor01) PDUFA Oct 10, 2026; WINREVAIR HYPERION PDUFA Sept 21, 2026.

Other catalysts: positive Phase 3 SMART topline for ENFLONSIA to prevent RSV disease in infants/children <2 over two seasons (also EC approval for newborns/infants in first season); initiation of pivotal Phase 2b/3 MALBEC and TORRONTES for MK‑8748 in neovascular AMD; planned readouts for islatravir/lenacapavir Phase 3 ISLEND‑1/‑2 (HIV treatment) and MK‑8748 Phase 2a RIOJA; and expected May close of the announced acquisition of Terns Pharmaceuticals adding TERN‑701 (allosteric BCR::ABL TKI) for CML.