Merck & Co Stock Price, News & Analysis

Merck (NYSE: MRK) announced that the FDA has accepted for review a supplemental Biologics License Application for KEYTRUDA as an adjuvant treatment for stage IB (≥4 cm), II, or IIIA non-small cell lung cancer (NSCLC) after surgical resection. This application is based on the Phase 3 KEYNOTE-091 trial, which showed improved disease-free survival (DFS) for patients. The FDA’s target action date is January 29, 2023. If approved, KEYTRUDA would be the first adjuvant immunotherapy option for these NSCLC stages post-surgery, expanding Merck's oncology portfolio.

Merck (NYSE: MRK) will participate in the 2022 Goldman Sachs 43rd Annual Global Healthcare Conference on June 13, 2022, at 3:20pm PT / 6:20pm ET. CEO Robert M. Davis and Dean Y. Li, President of Merck Research Laboratories, will engage in a fireside chat. The event invites investors, analysts, and the public to listen live at this link. Merck continues to leverage scientific advancements to enhance health solutions globally, emphasizing innovation and responsibility.

Merck and Ridgeback Biotherapeutics report new data from the Phase 3 MOVe-OUT trial for LAGEVRIO (molnupiravir), an oral antiviral for high-risk COVID-19 patients. Key findings show a 32.1% reduction in acute care visits in LAGEVRIO patients versus placebo. The need for respiratory interventions was 34.3% lower in LAGEVRIO-treated participants. Those hospitalized after randomization had a median discharge time of 9 days vs. 12 days for placebo. LAGEVRIO has demonstrated significant efficacy in reducing severe COVID-19 progression.

Merck (NYSE: MRK) is poised for significant growth in oncology, with over 80 potential drug approvals anticipated by 2028. During the ASCO Annual Meeting, the company presented nearly 120 abstracts covering more than 25 cancer types, showcasing its comprehensive oncology portfolio. Merck has achieved 12 FDA approvals in the past year, including five for early-stage cancers. The firm emphasizes its commitment to advancing cancer treatment through a diverse pipeline targeting various cancer mechanisms, including immuno-oncology and molecular therapies.

Merck announced positive results from the Phase 3 KEYNOTE-716 trial of KEYTRUDA, demonstrating a significant improvement in distant metastasis-free survival (DMFS) for patients with resected stage IIB and IIC melanoma. With a median follow-up of 27.4 months, KEYTRUDA showed a DMFS hazard ratio of 0.64 and a recurrence-free survival (RFS) hazard ratio of 0.64 as well. The drug received FDA approval for adjuvant treatment of this patient group and a positive opinion from the EU CHMP. Safety data indicated a consistent profile with previous studies, though higher rates of adverse events were noted.

Merck (NYSE: MRK) has declared a quarterly dividend of $0.69 per share for Q3 2022. This dividend will be paid on July 8, 2022, to shareholders on record as of June 15, 2022. The company continues to focus on advancing health solutions through innovative research and development in the biopharmaceutical sector.

The European Commission has approved Merck's KEYTRUDA in combination with chemotherapy for adults with high-risk early-stage triple-negative breast cancer (TNBC). This decision, based on the Phase 3 KEYNOTE-522 trial, demonstrated a 37% reduction in the risk of event-free survival (EFS) events compared to chemotherapy alone. The approval represents the first immunotherapy option for this patient group in the EU and the fifth indication for KEYTRUDA in breast or gynecologic cancer in less than a year. The treatment is now available across all 27 EU member states.

Merck (NYSE: MRK) has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommending the approval of KEYTRUDA as an adjuvant treatment for stage IIB and IIC melanoma in patients aged 12 and older following complete resection. This follows successful results from the Phase 3 KEYNOTE-716 trial, which showed significant improvements in recurrence-free and distant metastasis-free survival compared to placebo. A final decision by the European Commission is anticipated in Q2 or Q3 of 2022.

Merck (NYSE: MRK) announced the presentation of data from six approved medicines and pipeline candidates targeting over 25 cancers at the 2022 ASCO Annual Meeting in Chicago from June 3-7. Highlights include findings from KEYTRUDA, WELIREG, LYNPARZA, and LENVIMA, alongside investigational therapies like favezelimab and MK-0482. Key data emphasize advancements in treatment for cancers such as melanoma, non-small cell lung cancer, and triple-negative breast cancer. An Oncology Investor Event will occur on June 7, providing insights into Merck's oncology strategy.