Merck & Co Stock Price, News & Analysis

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.

Merck (NYSE: MRK) announced that Michael T. Nally, chief marketing officer, will speak at the Barclays Global Healthcare Conference on March 9, 2021, at 1:50 p.m. EST. Investors, analysts, and the public are invited to watch the live video webcast through Merck's investor events page.

Merck, dedicated to advancing health through medicines and vaccines, continues to focus on combating serious diseases, including cancer and infectious diseases. For more details, visit www.merck.com.