Merck & Co., Inc. - MRK STOCK NEWS

Merck (NYSE: MRK) announced a definitive agreement for Organon to acquire Alydia Health, a company focused on preventing maternal morbidity and mortality from postpartum hemorrhage. The deal is valued up to $240 million, comprising $215 million upfront and a $25 million contingent payment. This acquisition aims to enhance Organon's strategy in women’s health and expand the market reach of Alydia’s Jada System. The transaction is expected to complete after the planned spinoff of Organon from Merck, anticipated in late Q2 2021.

Merck (NYSE: MRK) received a positive opinion from the CHMP of the EMA to update the European label for KEYTRUDA, its anti-PD-1 therapy. This update incorporates data from KEYNOTE-361, a Phase 3 trial evaluating KEYTRUDA for advanced or metastatic urothelial carcinoma. Although KEYNOTE-361 missed its primary endpoints for progression-free and overall survival, the CHMP affirmed a favorable benefit-risk profile, allowing healthcare providers to better assess patient treatment options.

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.