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Merck & Co., Inc. reports news across a global pharmaceutical business known as MSD outside the United States and Canada. Company updates center on human health products for areas such as oncology, cardiometabolic disease and infections; vaccines including Gardasil; and Merck Animal Health medicines, devices and customer-support systems.
Recurring developments include FDA approvals, clinical and regulatory disclosures, research publications, pipeline additions, business development transactions, material agreements, capital-structure updates, governance matters, and operating and financial results. Recent themes include the approved HIV-1 regimen IDVYNSO, investigational programs such as enlicitide decanoate and TERN-701, technology partnerships for research, manufacturing and commercial functions, and animal health digital engagement initiatives.
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.
Merck (NYSE: MRK) announced a virtual investor event focused on its extensive HIV program and a recent collaboration with Gilead Sciences. Investors, analysts, and the public can participate via a live audio webcast. Merck has a long-standing commitment to HIV research, aiming to address unmet medical needs and collaborate with global partners to combat the epidemic. The company emphasizes its mission to enhance healthcare access and improve lives through innovative medicines and vaccines.
Gilead Sciences (GILD) and Merck (MRK) have entered a collaboration to co-develop long-acting HIV treatments using Gilead's capsid inhibitor, lenacapavir, and Merck's nucleoside reverse transcriptase translocation inhibitor, islatravir. Both compounds are in late-stage clinical trials. The agreement involves equal sharing of global product revenues after certain sales thresholds, with Gilead leading U.S. marketing for oral formulations and Merck for injectables. This partnership aims to address the need for innovative, less frequent dosing options for HIV patients.
Merck (NYSE: MRK) has announced promising results from a Phase 1 study of its investigational islatravir subdermal implant for HIV-1 pre-exposure prophylaxis (PrEP). The study, presented at CROI 2021, showed active drug levels exceeding the necessary PK threshold at 12 weeks across all studied doses (48 mg, 52 mg, and 56 mg), with the 56 mg dose projected to provide effective drug levels for up to a year. Merck plans to initiate a Phase 2 trial to further assess this long-acting option for HIV prevention.
Merck and Ridgeback Biotherapeutics announced preliminary results from a Phase 2a trial evaluating molnupiravir for SARS-CoV-2 treatment. The study showed a significant reduction in days to negativity of infectious virus in participants receiving molnupiravir compared to placebo (0% vs. 24%). This multi-center trial enrolled 202 adults, and no safety signals were identified. The primary results remain blinded. Further studies are underway, with updates planned in the future. Molnupiravir is an investigational oral antiviral showing promise against various RNA viruses including SARS-CoV-2.
Merck (NYSE: MRK) has initiated a cash tender offer for all outstanding shares of Pandion Therapeutics, Inc. (Nasdaq: PAND), offering $60 per share. This acquisition aims to enhance Merck's portfolio and is expected to close in the first half of 2021, subject to specific conditions. Stockholders are encouraged to accept the offer, detailed in the tender offer statement filed with the SEC. Merck’s acquisition signifies a strategic expansion and potential revenue growth as it continues focusing on innovative therapeutics.