Merck & Co Stock Price, News & Analysis

Merck (NYSE: MRK) received a Complete Response Letter (CRL) from the FDA regarding the supplemental Biologics License Application for KEYTRUDA, intended for high-risk early-stage triple-negative breast cancer treatment. The application, based on data from the KEYNOTE-522 trial, was deferred by the FDA's advisory committee pending additional data. The next interim analysis is slated for Q3 2021. This CRL does not affect existing approvals for KEYTRUDA, which includes treatment for locally recurrent or metastatic TNBC with PD-L1 expression.

Merck (NYSE: MRK) will hold its first-quarter 2021 sales and earnings conference call on April 29 at 8:00 a.m. EDT. This call aims to provide an overview of the company’s performance for the quarter to investors and analysts. A live audio webcast will be accessible via Merck’s website, along with a replay and supplemental financial disclosures. Merck has a long-standing commitment to research and development in healthcare, focusing on areas such as cancer and infectious diseases. Forward-looking statements in this release are subject to risks and uncertainties that could impact actual results.

Merck (NYSE: MRK) has appointed Caroline Litchfield as its new executive vice president and chief financial officer (CFO), effective April 1, 2021. Litchfield, previously the company's treasurer, succeeds Robert M. Davis, who will become president and then CEO on July 1, 2021. Merck's leadership highlights Litchfield's financial expertise and track record as critical for ensuring the company's sustainable financial strength. Her extensive experience within Merck, including leading finance for its largest business, positions her well for this pivotal role.

Merck announced that the FDA has approved KEYTRUDA for treating locally advanced or metastatic esophageal carcinoma in combination with chemotherapy. This approval is based on the Phase 3 KEYNOTE-590 trial, which showed a 27% reduction in the risk of death and a 35% reduction in disease progression compared to chemotherapy alone. KEYTRUDA demonstrated an overall response rate of 45% versus 29% in the control group. Although effective, KEYTRUDA carries risks of severe adverse reactions, requiring careful management.

Merck and Eisai presented pivotal data from the Phase 3 KEYNOTE-775/Study 309 trial at the SGO 2021 Annual Meeting, showcasing the combination of KEYTRUDA and LENVIMA for advanced endometrial cancer. The study met primary endpoints: a 44% reduction in disease progression risk (median PFS of 7.2 months vs. 3.8 months) and a 38% reduction in death risk (median OS of 18.3 months vs. 11.4 months) compared to chemotherapy. The overall response rate was 31.9%. These results support the therapy's use in patients with challenging treatment scenarios.

Merck (NYSE: MRK) has filed a Form 10 registration with the SEC for its spinoff of women's health, biosimilars, and established brands into a new company, Organon. The Form 10 contains historical financial data and a strategic overview of Organon. The spinoff is expected to enhance growth and operational focus, benefiting both companies. Completion is subject to various conditions, including regulatory approvals and board approval, with an anticipated completion by late Q2 2021. Organon aims to prioritize women's health, featuring a diverse board with 70% female representation.

Merck (NYSE: MRK) announced that the European Commission has approved an expanded indication for KEYTRUDA to treat relapsed or refractory classical Hodgkin lymphoma (cHL) in patients aged 3 or older who failed autologous stem cell transplant or other therapies. This approval is based on the KEYNOTE-204 trial, which showed a 35% reduction in disease progression risk with KEYTRUDA compared to brentuximab vedotin, reporting a median progression-free survival of 13.2 months versus 8.3 months. This marks the first pediatric approval for KEYTRUDA in the EU.

Merck (NYSE: MRK) announced the departure of Michael T. Nally, chief marketing officer of Human Health, effective end of March, for a new leadership role elsewhere. Frank Clyburn, currently chief commercial officer, will succeed Nally as president of Human Health. Clyburn will oversee global marketing and commercial operations, reporting to Kenneth C. Frazier until April 1, 2021, when Robert M. Davis will take over as president and CEO. Clyburn has been instrumental in expanding Merck’s oncology business since joining the company in 2008.

Merck (NYSE: MRK) announced the FDA's acceptance and priority review for a New Drug Application (NDA) for belzutifan, a HIF-2α inhibitor, targeting renal cell carcinoma (RCC) linked to von Hippel-Lindau (VHL) disease. The NDA is based on a Phase 2 Study-004 showing a 36.1% response rate among patients. The PDUFA date is set for September 15, 2021. Belzutifan has potential applications in advanced RCC and other tumors, enhancing Merck’s oncology pipeline.