Merck & Co., Inc. - MRK STOCK NEWS

Merck (MRK) announced the FDA's approval of KEYTRUDA, an anti-PD-1 therapy, for treating high-risk early-stage triple-negative breast cancer (TNBC) alongside chemotherapy. This approval follows the Phase 3 KEYNOTE-522 trial, which showed a 37% reduction in disease progression risk. KEYTRUDA is currently approved for 30 indications in the U.S. The treatment addresses a significant unmet need, particularly affecting younger and Black women. However, immune-mediated adverse reactions may occur, necessitating close monitoring during treatment.

Merck (MRK) and Eisai announced that the FDA approved the combination of KEYTRUDA and LENVIMA for treating advanced endometrial carcinoma in patients with specific conditions. This approval follows the Phase 3 KEYNOTE-775/Study 309 trial, showing a 32% reduction in death risk and 40% reduction in disease progression compared to chemotherapy. The combination achieved a 30% objective response rate, surpassing the 15% rate of traditional treatments. However, severe adverse reactions can occur with both medications.

Merck (MRK) announced that the European Commission has granted marketing authorization for VERQUVO® (vericiguat) in the EU. This medication is approved for treating symptomatic chronic heart failure in adult patients with reduced ejection fraction post intravenous therapy. Following its U.S. FDA approval in January, VERQUVO is also recognized in Japan. This collaboration with Bayer AG aims to enhance heart failure treatment options. However, patients must be advised against its use during pregnancy due to potential fetal harm.

Merck (NYSE: MRK) announced positive results from a Phase 2a clinical trial of islatravir, an investigational HIV-1 PrEP agent, demonstrating safety and tolerability over 24 weeks. Approximately 92% of the 242 participants completed the study with most adverse events being mild. Notably, islatravir maintained effective levels in blood cells, exceeding the efficacy threshold eight weeks post-treatment. The study emphasizes Merck's commitment to diverse populations at risk for HIV. Further evaluations are planned, including two Phase 3 trials.

Merck announced FDA approval for VAXNEUVANCE, a 15-valent pneumococcal conjugate vaccine aimed at preventing invasive disease caused by various Streptococcus pneumoniae serotypes in adults aged 18 and older. This approval follows a Priority Review and is backed by extensive clinical studies demonstrating non-inferior and superior immune responses compared to the existing 13-valent vaccine, PCV13. The CDC's ACIP will soon discuss recommendations for its use. VAXNEUVANCE targets serotypes known for significant disease burden, including 3, 22F, and 33F.

Merck (NYSE: MRK) announced significant positive event-free survival (EFS) results from the KEYNOTE-522 trial for high-risk early-stage triple-negative breast cancer (TNBC). After 39 months of follow-up, the KEYTRUDA regimen showed a 37% reduction in EFS events compared to chemotherapy-placebo (HR=0.63). Notably, 84.5% of KEYTRUDA patients remained EFS at three years. The treatment's safety profile was consistent, with no new safety concerns. These findings support KEYTRUDA's potential in TNBC, leading to an FDA application for broader use.

Merck (NYSE: MRK) presented new data from its HIV clinical development program at the 11th International AIDS Society Conference on HIV Science from July 18-21. Key highlights include results from a Phase 2a study of islatravir for pre-exposure prophylaxis (PrEP) and 96-week data on islatravir combined with doravirine for treatment-naïve adults. Merck emphasizes its commitment to HIV research and the potential of islatravir in future treatment regimens. The company remains focused on advancing its HIV portfolio amid ongoing challenges in the industry.

Merck (NYSE: MRK) and Ridgeback Biotherapeutics announced the presentation of Phase 2 interim results for molnupiravir, an investigational oral antiviral for COVID-19, at the European Congress of Clinical Microbiology & Infectious Diseases (ECCMID). The ongoing Phase 3 MOVe-OUT trial targets non-hospitalized patients with COVID-19 risk factors. Merck plans to initiate a new program for post-exposure prophylaxis later this year. Dr. Roy Baynes emphasized the critical need for antiviral treatments, while Ridgeback's CEO expressed hope for molnupiravir's role in pandemic solutions.

Merck (NYSE: MRK) announced FDA approval for an expanded label for KEYTRUDA as monotherapy for locally advanced cutaneous squamous cell carcinoma (cSCC) unresponsive to surgery or radiation. This decision follows a Phase 2 KEYNOTE-629 trial, showing a 50% objective response rate (ORR) with a 17% complete response rate and a 33% partial response rate. Among responders, 81% maintained response for over six months. The approval highlights KEYTRUDA's efficacy for cSCC, the second most common non-melanoma skin cancer.