Merck & Co., Inc. - MRK STOCK NEWS

Merck (NYSE: MRK) announced that the European Medicines Agency's CHMP has recommended approving KEYTRUDA for first-line treatment in adults with locally advanced or metastatic esophageal carcinoma and HER2-negative gastroesophageal junction adenocarcinoma whose tumors express PD-L1. This positive opinion is based on the Phase 3 KEYNOTE-590 trial, showing KEYTRUDA significantly improves overall and progression-free survival. A final decision from the European Commission is expected in Q2 2021, highlighting the urgent need for new treatment options in this patient population.

Merck (NYSE: MRK) announced that its investigational 15-valent pneumococcal conjugate vaccine, V114, achieved primary immunogenicity and safety endpoints in two Phase 3 trials. The PNEU-DIRECTION study showed comparable immune responses in infants previously vaccinated with the 13-valent PCV13, while the PNEU-PLAN study demonstrated V114's effectiveness in catch-up vaccinations for children aged 7 months to 17 years. V114 was well-tolerated, and the company plans to submit regulatory applications to the FDA by year-end.

On May 17, 2021, Merck (NYSE: MRK) and Vaccinate Your Family launched the Don't Skip campaign to promote well-visits and vaccinations, featuring actress Gabrielle Union-Wade. The campaign addresses a significant drop in childhood vaccinations, with reports indicating a 26% decrease from January to September 2020 due to pandemic-related fears. The initiative stresses the importance of keeping scheduled appointments amid reopening public venues. Merck emphasizes its commitment to public health and the urgent need to resume vaccinations to combat vaccine-preventable diseases.

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.