Merck & Co Stock Price, News & Analysis

Merck (NYSE: MRK) announced that KEYTRUDA has received two approvals from Japan's Pharmaceuticals and Medical Devices Agency. The first approval allows its use in treating PD-L1-positive, hormone receptor-negative, and HER2-negative, inoperable or recurrent breast cancer, based on the KEYNOTE-355 trial results. The second approval is for unresectable, advanced, or recurrent high microsatellite instability colorectal cancer, based on KEYNOTE-177 results. KEYTRUDA now has 15 authorized uses in Japan, supporting the company's commitment to cancer care.

Merck (NYSE: MRK) announced positive topline results from the pivotal PNEU-PED (V114-029) study, evaluating the safety and immunogenicity of VAXNEUVANCE, a 15-valent pneumococcal conjugate vaccine, in infants aged 42-90 days. The study showed that VAXNEUVANCE had a safety profile comparable to PCV13, meeting primary endpoints for immunogenicity after 3 and 4 doses. Additionally, VAXNEUVANCE demonstrated superior immune responses for specific serotypes. The Phase 3 PNEU-LINK study also confirmed the vaccine's favorable safety profile, with full results to be shared at a scientific congress.

Merck (NYSE: MRK) announced the resignation of Leslie A. Brun, its independent lead director, effective August 19, 2021. Brun is stepping down to become chairman and CEO of Ariel Alternatives, a private equity initiative focused on scaling minority-owned businesses as tier 1 suppliers to Fortune 500 companies. Merck is considering an investment in Ariel Alternatives. CEO Rob Davis acknowledged Brun's contributions and expressed support for his new role. The company plans to appoint a new independent lead director soon.

Merck (NYSE: MRK) has received FDA approval for WELIREG, an oral HIF-2α inhibitor, to treat adult patients with von Hippel-Lindau (VHL) disease requiring therapy for associated renal cell carcinoma (RCC), central nervous system hemangioblastomas, or pancreatic neuroendocrine tumors (pNET). This approval marks WELIREG as the first systemic therapy for certain VHL-associated tumors in the U.S. The treatment showed a significant overall response rate (ORR) of 49% in RCC patients and is vital for addressing an unmet medical need.

Merck and Eisai announced FDA approval for the combination of KEYTRUDA and LENVIMA as a first-line treatment for advanced renal cell carcinoma (RCC). This decision is based on results from the pivotal Phase 3 CLEAR (Study 307)/KEYNOTE-581 trial, which showed significant improvements in progression-free survival (PFS) and overall survival (OS) compared to sunitinib. KEYTRUDA plus LENVIMA reduced disease progression or death by 61%, with median PFS of 23.9 months versus 9.2 months for sunitinib. 71% of patients achieved confirmed objective response rate, indicating strong efficacy for this cancer therapy.

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.