MRK News & Events

Stock futures edged higher Friday morning as markets headed toward a weekly gain despite continued volatility. Treasury yields have eased, lifting megacaps and chip stocks, though markets continue to be on watch for signs of a breakthrough in negotiations to end the war in Iran.In pre-market trading, S&P 500 futures increased 0.35%, Nasdaq 100 futures were up 0.38% and Dow futures gained 0.60%.Check out this morning's top movers from around Wall Street, compiled by The Fly.HIGHER -Imaxup 14% following a WSJ report that the company is considering a saleEstee Lauderup 12% after the company and Puigconfirmed that they have ended talks about a potential combinationMerckup 3% after its treatment for lung cancer in partnership with Chinese-based Kelun-Biotech cut tumor progression risk by 65% in a Phase 3 studyPerpetua Resourcesup 8% after the company announced that it has secured a $2.9B loan from the U.S. Export-Import BankSweetgreenup 9% after being upgraded at JPMorgan on its ramping brand transformationUP AFTER EARNINGS -Ross Storesup 5%Workdayup 7%Zoom Communicationsup 8%Take-Twoup 4%Booz Allenup 4%DOWN AFTER EARNINGS -Deckers Outdoordown 3%LOWER -Futudown 38% after Reuters reported that China is launching a crackdown on illegal cross-border securities trading

Merck announced the European Medicines Agency's Committee for Medicinal Products for Human Use adopted a positive opinion recommending approval of KEYTRUDA, Merck's anti-PD-1 therapy, in combination with Padcev, an antibody-drug conjugate, as neoadjuvant treatment and then continued after radical cystectomy as adjuvant treatment, for adults with resectable muscle-invasive bladder cancer who are ineligible for cisplatin-containing chemotherapy. This recommendation, which also includes KEYTRUDA SC, will now be reviewed by the European Commission for marketing authorization in the European Union, Iceland, Liechtenstein and Norway, and a final decision is expected by the third quarter of 2026. The recommendation is based on results from the Phase 3 KEYNOTE-905 trial. In the study, KEYTRUDA plus Padcev, as perioperative treatment, demonstrated statistically significant and clinically meaningful improvements in event-free survival, overall survival and pathologic complete response rate versus surgery alone in patients with MIBC who are not eligible for or declined cisplatin-based chemotherapy. The KEYTRUDA plus Padcev regimen reduced the risk of EFS events by 60% versus surgery alone. Median EFS was not reached for the KEYTRUDA plus Padcev regimen versus 15.7 months for surgery alone. KEYTRUDA plus Padcev also reduced the risk of death by 50% versus surgery alone. Median OS was not reached for the KEYTRUDA plus Padcev regimen versus 41.7 months for surgery alone. The trial demonstrated a statistically significant difference in pCR rate.

Kelun-Biotech reported that its TROP2-directed ADC sacituzumab tirumotecan combined with pembrolizumab showed a statistically significant and clinically meaningful improvement in progression-free survival versus pembrolizumab alone in first-line PD-L1-positive metastatic NSCLC, alongside a markedly higher response rate, with results selected for oral presentation at ASCO. next-generation RET inhibitor lunbotinib showed high clinical activity in a pivotal Phase II study of RET-fusion positive NSCLC, with ORR of 87.1% in pre-treated and 81.3% in treatment-naive patients, long median PFS, and durable survival signals with 24-month OS rates up to 74.1%, supporting strong efficacy in both treatment settings.

Two registrational studies of the trophoblast cell-surface antigen 2-directed antibody drug conjugate sacituzumab tirumotecan, or sac-TMT, and the next-generation selective rearranged during transfection inhibitor lunbotinib fumarate from Kelun-Biotech have been selected for oral presentation session on Lung Cancer - Non-Small Cell Metastatic at the 2026 American Society of Clinical Oncology Annual Meeting to be held in Chicago from May 29 to June 2, local time, the company reported. A total of 413 patients with previously untreated locally advanced or metastatic NSCLC without epidermal growth factor receptor or anaplastic lymphoma kinase alterations and with programmed death ligand 1 positive, covering both squamous and non-squamous histologies, were enrolled and randomized to receive sac-TMT plus pembrolizumab or pembrolizumab monotherapy. The primary endpoint was progression-free survival assessed by blinded independent central review, and the key secondary endpoint was overall survival. As of September 29, 2025, the median follow-up was 10.5 months. "OptiTROP-Lung05 is the first Phase III clinical study demonstrating a significant improvement in PFS and a positive trend in OS with an ADC combined with pembrolizumab compared to pembrolizumab in first-line treatment for PD-L1 positive advanced NSCLC. Based on these results, a supplemental New Drug Application for this combination regimen has been accepted for review and included in the priority review and approval process by the National Medical Products Administration (NMPA) in China," the company stated. In May 2022, the company licensed the exclusive rights to Merck to develop, use, manufacture and commercialize sac-TMT in all territories outside of Greater China, which includes Mainland China, Hong Kong, Macao and Taiwan.