Merck & Co Stock Price, News & Analysis

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.

Merck (NYSE: MRK) has announced its decision to voluntarily withdraw the U.S. accelerated approval for KEYTRUDA in treating recurrent locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma, following a failure to demonstrate an overall survival benefit in a Phase 3 study. This decision, made after consultation with the FDA, will be initiated in six months. KEYTRUDA remains approved for other indications, including first-line treatment with trastuzumab for HER2-positive gastric cancer and for certain solid tumors with specific genetic markers.

Merck (NYSE: MRK) will host its second-quarter 2021 sales and earnings conference call on July 29 at 8:00 a.m. EDT. Company executives will provide an overview of performance for the quarter. A live audio webcast will be available on Merck's website, with a replay and financial disclosures to follow. Institutional investors and analysts can participate by dialing specific numbers and using the provided ID code. Merck has a longstanding commitment to advancing healthcare through innovative medicines and vaccines for serious diseases.

OneTen, a coalition of CEOs, has launched a new Talent platform aimed at hiring, upskilling, and promoting one million Black individuals without four-year degrees over the next decade. Collaborating with Bain & Company, IBM, and Merck, the platform facilitates career paths and skill development. The platform will be available to member employers in Q4 2021, enhancing accessibility to job opportunities. By employing a skills-first approach, OneTen aims to combat bias in hiring, providing equitable access to careers for Black talent while leveraging advanced AI and blockchain technologies.

Merck (NYSE: MRK) announced that the European Commission has approved KEYTRUDA for first-line treatment of adults with unresectable or metastatic esophageal carcinoma or HER2-negative gastroesophageal junction adenocarcinoma. The approval follows the Phase 3 KEYNOTE-590 trial, showing significant improvements in overall survival (OS) and progression-free survival (PFS). KEYTRUDA combined with chemotherapy reduced the risk of death by 27% and disease progression by 35%. The combination therapy received marketing approval across all EU member states and other countries, marking a significant advancement in treatment options.

Merck (NYSE: MRK) has appointed Michael Klobuchar as executive vice president and chief strategy officer, effective July 5, 2021. This new role aims to enhance the execution of Merck’s strategic initiatives. Klobuchar, who brings extensive experience from his previous roles at Merck, expressed enthusiasm for leveraging the company's scientific capabilities. President Rob Davis highlighted Klobuchar's insights and commitment to innovation as critical for the company’s evolution and longstanding legacy in health solutions.

AstraZeneca and Merck announced that LYNPARZA received conditional approval in China for treating adult patients with BRCA-mutated metastatic castration-resistant prostate cancer (mCRPC) who have progressed after new hormonal therapies. The approval is based on Phase 3 PROfound trial results, demonstrating a 78% reduction in disease progression and a 37% decrease in mortality risk with LYNPARZA compared to abiraterone or enzalutamide. The drug improves radiographic progression-free survival to 9.8 months versus 3.0 months. Approval continues pending further verification through ongoing trials.

Merck (NYSE: MRK) announced that its Phase 3 KEYNOTE-826 trial for KEYTRUDA in combination with platinum-based chemotherapy has met primary endpoints in treating persistent, recurrent, or metastatic cervical cancer. This regimen showed significant improvements in overall survival (OS) and progression-free survival (PFS) compared to standard treatments, marking a key advancement in first-line immunotherapy for cervical cancer. Results will be presented at a medical meeting and submitted for regulatory review. KEYTRUDA's safety was consistent with prior studies.