Merck & Co Stock Price, News & Analysis

Merck (NYSE: MRK) announced positive results from the Phase 3 KEYNOTE-522 trial for KEYTRUDA in treating high-risk early-stage triple-negative breast cancer (TNBC). The trial met its primary endpoint, demonstrating a statistically significant improvement in event-free survival when combining KEYTRUDA with chemotherapy versus chemotherapy alone. The safety profile remained consistent with previous studies, showing no new safety signals. Merck aims to collaborate with the FDA to expedite the treatment's availability to patients.

Merck (NYSE: MRK) announced the spinoff of Organon & Co. and declared a special dividend of one-tenth of a share of Organon for each Merck share outstanding as of May 17, 2021. The spinoff will be completed on June 2, 2021, with trading under the symbol 'OGN' starting the following day. This strategic move aims to enhance women's health and position Organon as an independent company. Merck shareholders will receive cash for any fractional shares. Following the announcement, market trading changes will occur for Merck shares under symbols 'MRK' and 'MRK.WI.'

Merck (NYSE: MRK) announced presentations at the 2021 ASCO Annual Meeting from June 4-8, showcasing data from over 20 cancer types.

Key highlights include new findings for its oncology portfolio, particularly for KEYTRUDA and LYNPARZA, detailing trials such as KEYNOTE-564 for renal cell carcinoma and OlympiA for breast cancer. Merck's oncology program aims to explore treatment combinations and new therapeutic avenues, emphasizing advancements in patient outcomes and cancer care innovations.

Merck (MRK) and Eisai announced that the FDA has accepted priority review for two new applications regarding the combination of KEYTRUDA and LENVIMA. These applications target the first-line treatment of advanced renal cell carcinoma and patients with advanced endometrial carcinoma who are not candidates for curative surgery. The applications are based on pivotal Phase 3 studies demonstrating statistically significant improvements in progression-free survival, overall survival, and objective response rates. Target action dates are set for August 25, 26, and September 3, 2021.

Merck announced that the FDA has approved KEYTRUDA in combination with trastuzumab and chemotherapy for first-line treatment of HER2-positive gastric or gastroesophageal junction adenocarcinoma. The approval, based on the Phase 3 KEYNOTE-811 trial, demonstrated a significant objective response rate (ORR) of 74% for the KEYTRUDA regimen compared to 52% for standard treatment.

However, this approval is under accelerated terms, hinging on further verification of clinical benefits.

Merck (NYSE: MRK) is hosting a meeting to discuss its spinoff of Organon, aiming to enhance growth and shareholder value. Rob Davis, Merck's president, emphasized that this separation will create a more agile company. Organon's launch on June 3 will feature over 60 products focused on women's health, biosimilars, and established brands. The new company expects low to mid-single organic revenue growth, with significant opportunities in the women's health market projected at over $60 billion by 2026. The event will outline Organon's growth strategy and commercial roadmap.

Merck (NYSE: MRK) reported its Q1 2021 financial results, showing total sales of $12.08 billion, a marginal increase from $12.057 billion in Q1 2020. GAAP net income fell by 1% to $3.179 billion, with GAAP EPS at $1.25. Non-GAAP EPS declined 7% to $1.40. Oncology sales were strong, led by KEYTRUDA, which grew 19% to $3.9 billion. However, the pandemic negatively impacted vaccine sales, particularly for GARDASIL, by approximately $230 million. Merck anticipates 2021 revenue growth of 8%-12%, with a GAAP EPS outlook of $5.05-$5.25.

Merck (NYSE: MRK) announced an upcoming virtual investor event on May 3 at 10:00 am EDT, where Organon management will unveil the business strategy and financial outlook for the spinoff company focused on women's healthcare. With over 60 established medicines, Organon aims to leverage a robust cash flow and commercial capabilities to foster growth and partnerships in international markets. Interested participants can pre-register for the event and access additional resources online.

Merck (NYSE: MRK) has entered into non-exclusive licensing agreements for molnupiravir with five Indian generics manufacturers to enhance its availability in India and over 100 low- and middle-income countries. This investigational oral antiviral agent is currently in a Phase 3 trial for non-hospitalized COVID-19 patients. The generics include Cipla, Dr. Reddy’s, Emcure, Hetero, and Sun Pharma. Additionally, Merck will donate over $5 million in aid to support relief efforts in India, highlighting its commitment to alleviating suffering amid the pandemic.