Merck & Co., Inc. - MRK STOCK NEWS

Merck (NYSE: MRK) announced results from two Phase 3 studies on V114, its 15-valent pneumococcal conjugate vaccine. In the PNEU-PATH study, V114 produced comparable immune responses to PCV13 in healthy adults 50+, with higher responses for serotypes 22F and 33F. The PNEU-DAY study showed similar findings in immunocompetent adults 18-49 with risk factors. V114 was well tolerated with a safety profile consistent with earlier studies. Plans for regulatory applications, starting with the FDA, are set for this year.

Merck (MRK) reported positive outcomes from two studies in its lung cancer treatment program, evaluating KEYTRUDA, an anti-PD-1 therapy. In the KEYNOTE-021 study, KEYTRUDA combined with chemotherapy showed improved objective response rates (58% vs. 33%), progression-free survival (PFS) of 24.5 months, and a median overall survival (OS) of 34.5 months compared to chemotherapy alone. Additionally, quavonlimab combined with KEYTRUDA demonstrated encouraging anti-tumor activity. The findings emphasize Merck's commitment to advancing lung cancer therapies and further trials, including a Phase 3 study, are planned.

Merck (NYSE:MRK) announced the FDA's approval of an expanded label for KEYTRUDA, its anti-PD-1 therapy, for adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL). This approval is based on the KEYNOTE-204 trial, showing a 35% reduction in disease progression risk (HR=0.65) compared to brentuximab vedotin, with a median progression-free survival of 13.2 months for KEYTRUDA versus 8.3 months for BV. An updated pediatric indication was also approved. The treatment offers a critical option for the estimated 8,500 annual U.S. cHL diagnoses, especially for younger patients.

Merck (NYSE: MRK) announced Week 96 results from a Phase 2b trial evaluating islatravir combined with doravirine for treating HIV-1 in treatment-naïve adults. The combination sustained virologic suppression, with 81.1% of participants maintaining HIV-1 RNA levels <50 copies/mL, comparable to DELSTRIGO. The 0.75 mg islatravir dose showed the most promise for further development. Additionally, MK-8507 demonstrated favorable antiviral potency, advancing to Phase 2 studies. No serious adverse events were noted, and renal safety analyses showed no significant concerns.

Merck (NYSE: MRK) announced that Dr. Roger M. Perlmutter will retire as Executive Vice President and President of Merck Research Laboratories (MRL) on January 1, 2021. He will be succeeded by Dr. Dean Y. Li, who has been pivotal in advancing MRL's pipeline. Under Perlmutter, MRL achieved over 100 global regulatory approvals, including the successful KEYTRUDA immunotherapy, now approved for over 25 indications. Perlmutter will transition to a non-executive director role until June 30, 2021.

Merck (NYSE: MRK) announced that nine abstracts from its HIV portfolio will be presented at the virtual HIV Glasgow 2020 congress, taking place from October 5-8, 2020. Highlights include data from the Phase 2b study of islatravir in combination with dorphirine showing 96-week efficacy and safety results, as well as findings from the DRIVE-SHIFT study. Merck emphasizes its commitment to developing innovative treatments for HIV, showcasing the diverse candidates in its pipeline.

Merck (NYSE:MRK) will hold its third-quarter 2020 sales and earnings conference call on October 27 at 8:00 a.m. EDT. Executives will discuss the company’s quarterly performance. The call will be accessible to investors and the public via a live audio webcast on Merck’s investor relations website. A replay will be available along with the sales and earnings news release. Merck, operational for over 125 years, focuses on developing medicines and vaccines for challenging diseases, aspiring to be a premier research-intensive biopharmaceutical company.

Merck Animal Health, a division of Merck & Co. (NYSE:MRK), launched a global campaign on World Rabies Day, September 28, to raise awareness about rabies prevention through dog vaccination. Partnering with Mission Rabies and Rabies Free Africa, the initiative emphasizes the importance of vaccinating dogs, which can save both canine and human lives. With an estimated 59,000 human deaths from rabies annually, mainly from dog bites, the campaign aims for a 70% vaccination rate in endemic areas. Merck has donated over three million rabies vaccine doses to support the WHO’s "Zero by 2030" goal.

TriRx Pharmaceutical Services has confirmed the acquisition of a manufacturing site from MSD Sante Animale, part of Merck & Co. (NYSE:MRK), located in Segré, France. This strategic move aims to enhance TriRx's global CDMO presence, ensuring continued supply of veterinary products. The facility, staffed by over ninety employees, is equipped for sterile suspensions and ointments, aligning with TriRx's growth in the animal health market. The agreement includes a long-term supply commitment and has received all necessary regulatory approvals, further positioning TriRx as a leader in contract manufacturing.