Merck & Co Stock Price, News & Analysis

Merck (MRK) announced positive Phase 3 trial results for subcutaneous pembrolizumab with berahyaluronidase alfa and chemotherapy in treating metastatic non-small cell lung cancer. The trial met its dual primary pharmacokinetic endpoints, demonstrating noninferiority compared to intravenous KEYTRUDA with chemotherapy. The subcutaneous administration takes only 2-3 minutes, potentially improving patient experience and healthcare access. Secondary endpoints for efficacy and safety were generally consistent between both administration methods. The results will be presented at an upcoming medical meeting and shared with regulatory authorities worldwide.

Merck (MRK) received a positive CHMP opinion recommending approval of KEYTRUDA in combination with pemetrexed and platinum chemotherapy for first-line treatment of adult patients with unresectable non-epithelioid malignant pleural mesothelioma (MPM). The recommendation is based on the Phase 2/3 IND.227/KEYNOTE-483 trial results, where KEYTRUDA plus chemotherapy showed significant improvement in overall survival, reducing death risk by 21% compared to chemotherapy alone. The treatment demonstrated median overall survival of 17.3 months versus 16.1 months for chemotherapy alone, and improved overall response rate (52% vs 29%). A final EU decision is expected in Q4 2024.

Merck (NYSE: MRK) has announced its participation in the upcoming Jefferies London Healthcare Conference. Joseph Romanelli, president of Human Health International, and Dr. Marjorie Green, senior vice president and head of oncology at Merck Research Laboratories, will engage in a fireside chat on Thursday, Nov. 21, 2024, at 6:30 a.m. EST / 11:30 a.m. GMT. The event will be accessible to investors, analysts, media, and the public through a live audio webcast.

Merck (MRK) has entered into an exclusive global license agreement with LaNova Medicines for LM-299, a novel investigational PD-1/VEGF bispecific antibody. Merck will pay an upfront payment of $588 million and potential milestone payments of up to $2.7 billion for the rights to develop, manufacture, and commercialize LM-299 across multiple indications. The transaction is expected to close in Q4 2024, subject to regulatory approvals. Merck will record a pre-tax charge related to the upfront payment in the quarter the transaction closes.

Merck (MRK) announced positive topline results from the Phase 3 KOMET trial of KOSELUGO in adults with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas. The trial demonstrated statistically significant and clinically meaningful improvement in objective response rate compared to placebo. KOSELUGO, an oral MEK inhibitor, showed a consistent safety profile with previous trials in children and adolescents, with no new safety signals identified. This rare genetic condition affects approximately 1.7 million people worldwide, with 70% being adults. Currently, there are no approved treatments for adults with NF1, making these results particularly significant for potential expanded use beyond pediatric patients.

Merck (MRK) announced new clinical and real-world data presentations for GARDASIL®9, their 9-valent HPV vaccine, at the International Papillomavirus Conference (IPVC) 2024 in Edinburgh. The presentations include results from the BROADEN and PROGRESS studies focusing on oral HPV infection prevalence and HPV-related cancers.

The data reinforces the importance of HPV vaccination for both males and females aged 9-45, highlighting that disease-causal HPV infection can occur later in life. Globally, approximately 666,000 new diagnoses of certain HPV-related cancers occur annually in men and women. The studies emphasize the growing incidence of HPV-related oropharyngeal and head and neck cancers, particularly in men.

Merck (NYSE: MRK) has announced its participation in the upcoming UBS Global Healthcare Conference. The company will be represented by Jannie Oosthuizen, president of Human Health U.S., and Dr. Joerg Koglin, senior vice president and head of general medicine, global clinical development at Merck Research Laboratories. The fireside chat is scheduled for Wednesday, Nov. 13, 2024, at 12:30 p.m. EST / 9:30 a.m. PST. A live audio webcast will be available for investors, analysts, media, and the general public.

Merck reported strong Q3 2024 financial results with total worldwide sales of $16.7 billion, up 4% from Q3 2023. KEYTRUDA sales grew 17% to $7.4 billion, while new launch WINREVAIR achieved sales of $149 million. Animal Health sales increased 6% to $1.5 billion. GAAP EPS was $1.24 and Non-GAAP EPS was $1.57, both including a $0.79 per share net charge from business development transactions. The company narrowed its full-year 2024 outlook, expecting worldwide sales between $63.6-64.1 billion and Non-GAAP EPS between $7.72-7.77.

Merck (MRK) and Moderna have initiated INTerpath-009, a Phase 3 clinical trial evaluating V940 (mRNA-4157) combined with KEYTRUDA for patients with resectable Stage II, IIIA or IIIB non-small cell lung cancer (NSCLC). The trial targets patients who didn't achieve complete response after neoadjuvant KEYTRUDA plus platinum-based chemotherapy. This marks the third Phase 3 trial for V940, focusing on earlier cancer stages. Patient enrollment has begun in Canada, expanding the companies' collaborative INTerpath clinical program which includes trials for melanoma, lung cancer, cutaneous squamous cell carcinoma, renal cell carcinoma, and urothelial carcinoma.