Merck & Co., Inc. - MRK STOCK NEWS

Merck (NYSE: MRK) announced the European Commission's approval of KEYTRUDA, an anti-PD-1 therapy, in combination with chemotherapy for first-line treatment of locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) in adults whose tumors express PD-L1 (CPS ≥10). This approval, based on the Phase 3 KEYNOTE-355 trial, showed a 27% reduction in the risk of death and a 34% reduction in disease progression compared to chemotherapy alone. KEYTRUDA is now available in all 27 EU member states and additional regions, marking a significant advancement in TNBC treatment options.

The Next Practices Group has appointed Ray Kerins as the new CEO of The Next Security Group (NextSec) starting November 1, enhancing its focus on public affairs and security, including cybersecurity and physical protection.

Kerins, who previously served in senior roles at Bayer, Pfizer (NYSE: PFE), and Merck (NYSE: MRK), aims to bolster the company’s offerings to protect and promote client reputations.

Merck (NYSE: MRK) announced that the CDC's Advisory Committee on Immunization Practices (ACIP) has unanimously recommended updates to pneumococcal vaccination for adults 65 and older, and adults 19 to 64 with specific health conditions. The committee suggested a sequential regimen of VAXNEUVANCE followed by PNEUMOVAX 23, or a single dose of the 20-valent vaccine. These recommendations aim to address the significant unmet need for preventing invasive pneumococcal disease (IPD) among at-risk populations. The final guidelines will be published in the CDC’s MMWR.

Darwin Global Management has issued a letter urging shareholders of Acceleron Pharma Inc. (XLRN) to reject Merck's (MRK) proposed acquisition offer of $180/share, which they deem significantly undervalued. With Acceleron's drugs, Reblozyl and sotatercept, projected to achieve peak sales exceeding $5 billion, Darwin estimates the company's equity value between $22 to $28 billion, potentially translating to a share price between $353 to $451. They argue that the intrinsic value of Acceleron will rise in the near future.

Merck (NYSE: MRK) is voluntarily recalling one lot of CUBICIN® (daptomycin for injection) due to a customer complaint reporting glass contamination in the vials. Approximately 22,000 vials from Lot 934778, expiring in June 2022, are affected. The recall is initiated to the user level and aims to prevent serious health risks associated with glass infusion. To date, there have been no reported adverse events linked to this issue. Customers with affected vials are instructed to contact Sedgwick for return instructions and prepaid shipping labels.

Merck (NYSE: MRK) and Eisai announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued positive opinions for the combination of KEYTRUDA and LENVIMA. This therapy targets advanced renal cell carcinoma (RCC) and advanced endometrial carcinoma (EC), showing significant improvements in overall survival (OS) and progression-free survival (PFS) in clinical trials. In the CLEAR/KEYNOTE-581 trial, KEYTRUDA plus LENVIMA reduced the risk of death by 34% and disease progression by 61% compared to sunitinib. The decision from the European Commission is expected by Q4 2021.

Merck (NYSE: MRK) announced that the European Medicines Agency’s CHMP has recommended the approval of VAXNEUVANCE, a 15-valent pneumococcal conjugate vaccine, for immunization against invasive disease and pneumonia caused by Streptococcus pneumoniae in adults 18 years and older. This recommendation is pending review by the European Commission, with a decision expected by year-end. VAXNEUVANCE is already FDA-approved in the U.S. for similar indications. The vaccine addresses the growing global prevalence of pneumococcal disease, particularly among vulnerable populations.

Holocene Advisors, a significant shareholder of Acceleron Pharma (XLRN), announced it will not tender its shares into Merck's (MRK) $180 per share offer. Holocene stated that the offer undervalues Acceleron, based on analysis and its strong pipeline, particularly the drug sotatercept, which shows promise for treating pulmonary arterial hypertension and could generate substantial sales. Holocene expressed concerns that proceeding with the current offer would deprive XLRN shareholders of significant value and highlighted the potential for increased value as more clinical data becomes available.

Merck (NYSE: MRK) has received FDA approval for KEYTRUDA in combination with chemotherapy, with or without bevacizumab, as a first-line treatment for patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥1). The approval is based on Phase 3 KEYNOTE-826 trial results, demonstrating improved overall survival (OS) and progression-free survival (PFS) with KEYTRUDA compared to chemotherapy alone. This marks an important advancement in treatment options for women with cervical cancer, particularly given the low survival rates in this population.