RAHWAY, N.J. - Merck & Co., Inc. (NYSE: MRK) has announced positive results from the STRIDE-8 Phase 3 trial of its pneumococcal 21-valent conjugate vaccine, CAPVAXIVE, presented at IDWeek 2024. The study, which compared CAPVAXIVE with existing vaccines, showed it was immunogenic across all 21 serotypes and had a favorable safety profile in adults with chronic conditions.
CAPVAXIVE targets serotypes responsible for approximately 84% of invasive pneumococcal disease (IPD) in adults aged 50 and over, based on CDC data from 2018-2021. The vaccine is designed for active immunization against invasive disease and pneumonia caused by Streptococcus pneumoniae serotypes in individuals 18 years and older.
The STRIDE-8 trial involved vaccine-naïve adults aged 18-64 with chronic conditions such as diabetes and heart disease. Participants were randomized to receive either CAPVAXIVE followed by a placebo, or PCV15 followed by PPSV23. Findings indicated that CAPVAXIVE elicited comparable or higher immune responses than the comparator vaccines and had numerically lower adverse events.
Additionally, Merck presented a targeted literature review at IDWeek, highlighting disparities in pneumococcal disease burden among U.S. adults, particularly in Black adults and those in rural areas with lower education and income levels. A modeling study also suggested that CAPVAXIVE could reduce IPD incidence by 33.9% over 10 years in the U.S., compared to PCV20.
CAPVAXIVE's approval for the prevention of pneumonia is based on immune response and is under accelerated approval pending further clinical benefit verification. It is contraindicated in individuals with severe allergic reactions to any of its components or diphtheria toxoid.
This announcement is based on a press release statement from Merck. The company continues to focus on addressing the specific needs of different populations, including at-risk groups, through its pneumococcal vaccine development program. CAPVAXIVE is administered as a single dose and aims to provide a new option for adult immunization against pneumococcal disease.
In other recent news, Exelixis (NASDAQ:EXEL) and Merck have announced a clinical development collaboration, focusing on the evaluation of Exelixis' investigational drug zanzalintinib in combination with Merck's anti-PD-1 therapy KEYTRUDA. Truist Securities has maintained a Buy rating on Exelixis, expressing confidence in zanzalintinib's potential and highlighting the collaboration's potential to increase revenue for Exelixis. The firms aim to enhance treatment options for patients with head and neck squamous cell carcinoma and renal cell carcinoma.
On the financial front, Truist Securities has adjusted its price target for Merck to $132.00, reflecting increased projected research and development expenses following Merck's acquisition of CN201 from Curon Biopharmaceutical. The acquisition also led to a reduction in Merck's earnings per share estimates, and adjustments in revenue estimates for Merck's vaccine, Gardasil.
Merck's KEYTRUDA has shown promise in a Phase 3 trial for patients with head and neck squamous cell carcinoma, meeting its primary endpoint of event-free survival. Analyst firms TD Cowen and BMO Capital Markets have maintained their Buy and Outperform ratings on Merck, respectively, citing the company's favorable position among its peers and the strong performance of its investigational therapy, ivonescimab. These are the recent developments in the operations of Exelixis and Merck.
InvestingPro Insights
Merck's positive results from the STRIDE-8 Phase 3 trial for CAPVAXIVE align with the company's strong market position and financial health. According to InvestingPro data, Merck boasts a substantial market capitalization of $281.9 billion, reflecting investor confidence in its product pipeline and growth potential.
The company's focus on innovative vaccines like CAPVAXIVE is supported by its robust financial performance. Merck's revenue growth of 7.15% over the last twelve months demonstrates its ability to expand its market presence. This growth is particularly significant in the competitive pharmaceutical industry, where Merck is recognized as a prominent player.
InvestingPro Tips highlight Merck's commitment to shareholder value. The company has maintained dividend payments for 54 consecutive years and has raised its dividend for 13 consecutive years. This consistent dividend policy, coupled with a current dividend yield of 2.76%, makes Merck an attractive option for income-focused investors.
The positive outlook for CAPVAXIVE's potential to reduce invasive pneumococcal disease incidence aligns with InvestingPro's expectation that Merck's net income will grow this year. This growth prospect is further supported by the company's strong profitability over the last twelve months.
Merck's financial stability is evident in its ability to cover interest payments with its cash flows, and it operates with a moderate level of debt. This financial prudence positions the company well to continue investing in research and development for products like CAPVAXIVE.
For investors seeking more comprehensive insights, InvestingPro offers an additional 11 tips for Merck, providing a deeper understanding of the company's financial health and market position.
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