CAMBRIDGE, MA – Moderna , Inc. (NASDAQ:) has initiated a Phase 3 clinical trial for its investigational norovirus vaccine, marking a significant step toward addressing the widespread public health issue posed by the virus. The first participant in the United States received a dose of the vaccine candidate, mRNA-1403, today as part of the Nova 301 Trial, which aims to evaluate the vaccine’s efficacy, safety, and immunogenicity.
The randomized, observer-blind, placebo-controlled Nova 301 Trial is set to enroll approximately 25,000 participants worldwide, including regions spanning the Northern Hemisphere, the equator, and the Southern Hemisphere. The study will focus on adults, with a significant emphasis on those aged 60 and above, who are at a heightened risk of severe outcomes from norovirus infection.
Norovirus is highly contagious and is a leading cause of acute gastroenteritis (AGE), contributing to around 18% of all such cases, which can lead to hospitalization and even death, especially among young children and the elderly. The virus is associated with approximately 200,000 deaths annually and imposes substantial healthcare costs.
The mRNA-1403 vaccine candidate is a trivalent formulation that targets multiple norovirus genotypes with the aim of preventing moderate to severe AGE caused by the virus. It uses mRNA technology to encode for virus-like particles (VLPs), which is a similar approach to that used in the development of one of the earliest and most effective COVID-19 vaccines.
Moderna’s CEO, Stéphane Bancel, highlighted the burden of norovirus on global health systems and expressed optimism about the vaccine’s potential impact on preventing infections.
The company, known for pioneering mRNA medicine, has leveraged its platform to create therapies and vaccines for a range of diseases, including infectious diseases, immuno-oncology, rare diseases, and autoimmune diseases.
While Moderna’s press release contains forward-looking statements regarding the vaccine’s potential and trial enrollment, these are not guarantees of future performance and are subject to risks and uncertainties.
The information in this article is based on a press release statement from Moderna, Inc.
In other recent news, Moderna Inc has received approval from Health Canada for its updated COVID-19 vaccine, SPIKEVAX®, targeting the KP.2 sub-lineage of SARS-CoV-2. This marks the first updated vaccine approved in Canada for the 2024-2025 season, with deliveries set to begin to the Public Health Agency of Canada.
Piper Sandler reduced the target for Moderna to $115 from $157, maintaining an Overweight rating, following Moderna’s goal for 10 mRNA product approvals by 2027 and estimated product sales between $3 billion and $3.5 billion for the current year. Oppenheimer downgraded Moderna stocks to a neutral “Perform” status amid a shift in R&D strategy, while RBC Capital reduced its price target for Moderna from $90 to $75, maintaining a Sector Perform rating.
Brookline Capital Markets reduced the price target to $238.00 from $310.00, but maintained a Buy rating, following changes in the prioritization and timing of projects that led to reduced revenue estimates for the years 2025 through 2030. Lastly, TD Cowen revised its price target for Moderna, reducing it to $60 from $70, while retaining a Hold rating. These are recent developments that investors should take into account.
InvestingPro Insights
As Moderna embarks on this critical Phase 3 trial for its norovirus vaccine, investors should consider the company’s current financial position and market performance. According to InvestingPro data, Moderna’s market capitalization stands at $25.27 billion, reflecting its significant presence in the biotech sector despite recent challenges.
The company’s revenue for the last twelve months as of Q2 2024 was $5.05 billion, but it’s important to note that revenue growth has declined by 52.6% over this period. This aligns with an InvestingPro Tip indicating that analysts anticipate a sales decline in the current year, which could be attributed to the waning demand for COVID-19 vaccines.
Another relevant InvestingPro Tip reveals that Moderna is quickly burning through cash. This is particularly pertinent as the company invests heavily in research and development for new vaccines like the norovirus candidate. However, it’s worth noting that Moderna holds more cash than debt on its balance sheet, which could provide some financial flexibility as it pursues this and other clinical trials.
The stock’s recent performance has been volatile, with a 44.63% decline over the past three months. This volatility, coupled with the fact that the stock is trading near its 52-week low, suggests that investors are reassessing Moderna’s value in a post-pandemic market.
For those interested in a deeper analysis, InvestingPro offers 13 additional tips for Moderna, providing a more comprehensive view of the company’s financial health and market position.
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