MRK · 10-Q · 2026Q2 · Full report

Regulatory Pipeline Progress

Merck & Co., Inc. · 2026-08-07 · Importance 23 · Surprise 24

Merck reported multiple products under regulatory review in the U.S., EU, Japan, and China as of August 5, 2026. FDA PDUFA target dates include October 10, 2026, for I-DXd in previously treated extensive-stage small-cell lung cancer, October 4, 2026, for the Welireg-Lenvima combination in advanced renal cell carcinoma, and September 21, 2026, for the Winrevair label update. Idvynso and Lipfendra are under review in the EU, with Lipfendra also under review in China, while several Keytruda and Welireg supplemental applications are under review in Japan and the EU. Merck and Gilead discontinued the Phase 3 KEYNOTE-D46/EVOKE-03 Trodelvy-Keytruda study after an external Data Monitoring Committee review, and Merck will discontinue a tulisokibart study in systemic-sclerosis-associated interstitial lung disease after it failed its primary endpoint.

Key facts

• Through the Terns acquisition, Merck acquired MK-4208 (formerly TERN-701), an investigational oral allosteric BCR::ABL1 TKI currently being evaluated in a Phase 1/2 trial for patients with Philadelphia chromosome-positive, chronic phase CML previously treated with at least one prior TKI. source
• Cidara’s lead DFC candidate, MK-1406 (formerly CD388), is a long-acting antiviral currently being evaluated in a Phase 3 trial among adult and adolescent participants at higher risk of influenza complications. source
• Keytruda received multiple regulatory approvals in 2026 including FDA approvals in February, June and July 2026 and EC approvals in March and June 2026; specific approvals include first-line treatment for certain endometrial cancer in China (Feb 2026) and FDA approval in June 2026 in combination with Welireg for adjuvant treatment in RCC. source
• Idvynso received FDA approval in April 2026 and Japan approval in March 2026 for a once-daily, two-drug single-tablet regimen for treatment of HIV-1 infection in adults meeting specified criteria. source