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RAHWAY, N.J. - Merck & Co ., Inc. (NYSE:MRK) has received a positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for its pneumococcal vaccine, CAPVAXIVE™. This endorsement is a critical step towards the vaccine’s potential marketing authorization within the European Union and additional countries including Iceland, Liechtenstein, and Norway. The European Commission is expected to finalize its decision by the second quarter of 2025.
CAPVAXIVE™ is aimed at the active immunization for the prevention of invasive pneumococcal disease (IPD) and pneumonia caused by Streptococcus pneumoniae in adults 18 years and older. According to Dr. Paula Annunziato of Merck (NSE:PROR) Research Laboratories, this development brings the company closer to protecting adults in the EU against these diseases, which can lead to severe health consequences such as hospitalization and death.
The vaccine covers 21 pneumococcal serotypes and is designed to target the majority of those responsible for IPD cases in adults. Country-level data from Germany, France, Italy, and Spain indicate that CAPVAXIVE covers a higher percentage of IPD cases compared to the 20-valent pneumococcal conjugate vaccine (PCV20), although no direct efficacy comparison studies have been conducted. This development aligns with Merck’s strong financial position, demonstrated by its impressive 76.59% gross profit margin and annual revenue of $63.17 billion.
The CHMP’s recommendation is supported by data from several Phase 3 clinical trials, including the pivotal STRIDE-3 trial, which compared CAPVAXIVE to PCV20 in adults who had not previously received a pneumococcal vaccine.
Merck has previously secured authorizations for CAPVAXIVE in the United States, Canada, and Australia, with the vaccine currently under review in Japan and additional worldwide regulatory filings in progress.
CAPVAXIVE is part of Merck’s portfolio of medicines and vaccines developed to address significant health challenges. The company emphasizes its commitment to scientific research and innovation, aiming to improve lives with its products.
This news is based on a press release statement from Merck & Co ., Inc. and has not been independently verified. The forward-looking statements in the press release are subject to risks and uncertainties, and there can be no guarantees that the vaccine will receive the necessary regulatory approvals or be commercially successful.
In other recent news, Merck & Co. has been at the center of several significant developments. The pharmaceutical giant announced a quarterly dividend of $0.81 per share and a $10 billion stock buyback, signaling its ongoing commitment to delivering value to its shareholders. Simultaneously, the company is facing a jury trial over allegations of improperly marketing its Gardasil cancer vaccine, with claims of exaggerating the vaccine’s benefits and downplaying its risks.
In addition to these financial and legal developments, Merck has also made strides in its product offerings. The U.S. Food and Drug Administration (FDA) has granted priority review to the company’s application for expanded use of its oral cancer drug, Welireg. If approved, this would make Welireg the only available therapy in the U.S. for patients with advanced pheochromocytoma and paraganglioma, rare tumors that form in and around the adrenal glands.
In collaboration with Eisai, Merck reported mixed results from their Phase 3 LEAP-015 trial, evaluating the efficacy of KEYTRUDA and LENVIMA combination therapy for patients with advanced gastroesophageal adenocarcinoma. Guggenheim Securities has adjusted its outlook on Merck shares, reaffirming a Buy rating but reducing the price target due to revised revenue forecasts for several of Merck’s products. These recent developments underscore Merck’s commitment to advancing its research and development pipeline and addressing unmet medical needs, despite facing litigation and mixed results in recent trials.
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