MRK News & Events

Merck announced that calderasib, an investigational oral specific KRAS G12C inhibitor, in combination with KEYTRUDA, Merck's anti-PD-1 therapy, has been granted Breakthrough Therapy designation by the U.S. FDA for the first-line treatment of patients with advanced or metastatic non-small cell lung cancer with KRAS G12C-mutation and expressing PD-L1. This is the first Breakthrough Therapy designation for calderasib and was supported by positive data from the Phase 1 KANDLELIT-001 trial.

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.