Merck & Co Stock Price, News & Analysis

Merck (NYSE: MRK) announced that the FDA has accepted its supplemental Biologics License Application for KEYTRUDA, targeting advanced endometrial carcinoma with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) characteristics. This application stems from data from KEYNOTE-158, which will be discussed at the upcoming ESMO Congress. The FDA's target action date is March 28, 2022. KEYTRUDA has previously received accelerated approval for similar cancer indications and is part of Merck's expanding oncology portfolio, aimed at addressing challenging women's cancers.

Merck (NYSE: MRK) announced that the FDA has accepted its supplemental Biologics License Application for KEYTRUDA, its anti-PD-1 therapy, for the adjuvant treatment of renal cell carcinoma (RCC) patients at high risk of recurrence post-nephrectomy. This priority review is based on pivotal Phase 3 KEYNOTE-564 trial data, showing significant improvement in disease-free survival compared to placebo. The PDUFA target action date is set for December 10, 2021. Merck continues to explore KEYTRUDA across various settings in RCC, with over 20 clinical studies involving more than 4,000 patients globally.

Merck (NYSE: MRK) announced that its Phase 3 KEYNOTE-716 trial for KEYTRUDA, an anti-PD-1 therapy, successfully met its primary endpoint of recurrence-free survival (RFS) in high-risk stage II melanoma patients after complete surgical resection. The interim analysis showed significant RFS improvement compared to placebo, with no new safety concerns reported. The FDA has accepted a supplemental Biologics License Application for KEYTRUDA in this indication, granting it Priority Review with a target action date of December 4, 2021. This marks a critical step in advancing melanoma treatment.

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.