Merck & Co Stock Price, News & Analysis

Merck (NYSE: MRK) announced the appointment of Cristal N. Downing as chief communications & public affairs officer, effective August 16, 2021. This new role within the Executive Team emphasizes enhanced communication strategies. CEO Rob Davis praised Downing's transformational leadership and experience in biopharmaceuticals, highlighting her previous role at Johnson & Johnson, where she led communication strategies and health equity initiatives. The company aims to strengthen its strategic impact and continue delivering essential innovations amid a growing focus on biopharmaceutical advancement.

Merck (NYSE: MRK) reported strong Q2 2021 results, with sales rising 22% to $11.4 billion. Non-GAAP EPS increased by 28% to $1.31, while GAAP EPS fell 48% to $0.48, impacted by a $1.7 billion charge for Pandion acquisition. KEYTRUDA sales were a highlight, growing 23% to $4.2 billion. Regulatory approvals for KEYTRUDA and Lynparza were announced, enhancing their oncology portfolio. Full-year guidance projects revenue between $46.4 and $47.4 billion, with an EPS range of $4.24 to $4.34. COVID-19's impact is expected to wane.

Merck (NYSE: MRK) announced a quarterly dividend of $0.65 per share for Q4 2021, payable on October 7, 2021 to shareholders of record on September 15, 2021. This decision reflects the company's ongoing commitment to returning value to shareholders while maintaining its focus on innovation in various therapeutic areas, including cancer and infectious diseases. Merck has been a leader in the biopharmaceutical industry for over 130 years, dedicated to improving lives through its medicines and vaccines.

Merck (NYSE: MRK) announced promising overall survival (OS) results from the Phase 3 KEYNOTE-355 trial for KEYTRUDA, its anti-PD-1 therapy, combined with chemotherapy for metastatic triple-negative breast cancer (mTNBC). The final analysis revealed a significant improvement in OS for patients whose tumors expressed PD-L1 (CPS ≥10) compared to chemotherapy alone. No new safety signals were detected. Merck is committed to expanding treatment options for this challenging cancer type, with these results expected to be presented at a major medical meeting and submitted to regulatory authorities.

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.