CAMBRIDGE, MA - Moderna , Inc. (NASDAQ:MRNA) has reported that its investigational mRNA-1083 vaccine, designed to target both influenza and COVID-19, has achieved its primary endpoints in a Phase 3 trial. The vaccine elicited stronger immune responses compared to the currently licensed flu and COVID-19 vaccines in adults aged 50 and above.
The Phase 3 trial, which included around 8,000 adult participants across two age cohorts, demonstrated that a single dose of mRNA-1083 produced immune responses that were non-inferior to those from separately administered Fluzone HD® and Spikevax® in the 65 and older group, and Fluarix® and Spikevax® in the 50 to 64 age group. Additionally, mRNA-1083 showed statistically significant higher immune responses against three influenza strains and the SARS-CoV-2 Omicron XBB.1.5 variant in both age cohorts.
Stéphane Bancel, CEO of Moderna, highlighted the potential benefits of combination vaccines such as mRNA-1083, including reduced burden on health systems and improved vaccination compliance. He also noted that Moderna is the only company with a positive Phase 3 flu and COVID combination vaccine.
mRNA-1083 combines elements of Moderna's seasonal influenza vaccine candidate mRNA-1010 and next-generation COVID-19 vaccine candidate mRNA-1283. Both components have previously shown positive results in independent Phase 3 clinical trials.
The trial's outcomes indicated acceptable tolerability and safety profiles for mRNA-1083, with the most common adverse reactions being mild to moderate in severity, such as injection site pain, fatigue, muscle pain, and headache.
Moderna plans to present the full data from this trial at an upcoming medical conference and submit it for publication in a peer-reviewed journal. The company will also engage with regulatory authorities regarding the next steps for mRNA-1083.
In other recent news, Moderna has been making significant strides in their biotechnology developments. Piper Sandler reaffirmed its positive stance on Moderna shares, maintaining an overweight rating and a $214.00 price target. The U.S. Food and Drug Administration (FDA) has approved Moderna's mRESVIA (mRNA-1345), set for a market launch this fall. Moderna's management expects product sales to reach at least $4.0 billion in 2024, with growth resuming in 2025.
In collaboration with Merck, Moderna has reported a notable reduction in recurrence or death in high-risk melanoma patients from their Phase 2b clinical trial. The combination of mRNA-4157 with KEYTRUDA resulted in a 49% reduction in risk compared to KEYTRUDA alone. Moderna's shares saw an upgrade from RBC Capital Markets following the approval of its Respiratory Syncytial Virus (RSV) vaccine.
Moderna, Pfizer (NYSE:PFE), BioNTech (NASDAQ:BNTX), and Novavax (NASDAQ:NVAX) have presented promising results for their updated COVID-19 vaccines, which have shown increased efficacy against new strains like KP.2.
The FDA will decide the focus of the upcoming immunization campaign based on these findings. Lastly, Moderna received FDA approval for mRESVIA, its mRNA-based vaccine designed to protect adults aged 60 and over from lower respiratory tract disease caused by the RSV. The company anticipates making mRESVIA available for the U.S. population in time for the 2024/2025 respiratory virus season.
InvestingPro Insights
As Moderna, Inc. (NASDAQ:MRNA) makes strides in vaccine development with its recent successful Phase 3 trial of mRNA-1083, the financial landscape of the company presents a mixed picture. According to real-time data from InvestingPro, Moderna's market capitalization stands at a robust $57.87 billion. However, the company's P/E ratio is negative at -9.77, reflecting investor concerns about profitability, especially since analysts do not anticipate the company will be profitable this year. This is further underscored by a substantial revenue decline over the last twelve months, with a -65.78% change as of Q1 2024.
Moderna's financial health shows some strong points as well. The company holds more cash than debt on its balance sheet, and its liquid assets exceed short-term obligations, indicating a position of financial stability. Additionally, despite concerns about profitability and sales decline, Moderna has experienced significant stock price appreciation, with a 51.85% year-to-date price total return.
For investors considering Moderna's stock, two InvestingPro Tips are particularly relevant: firstly, 9 analysts have revised their earnings upwards for the upcoming period, suggesting potential for future growth. Secondly, the company has demonstrated a strong return over the last month, with a 28.73% increase. While past performance is not indicative of future results, these metrics can be useful for investors making informed decisions.
For those seeking more in-depth analysis, InvestingPro offers additional tips on Moderna's financial metrics and prospects. To discover these insights, visit InvestingPro's Moderna page. Moreover, readers can utilize the coupon code PRONEWS24 to get an extra 10% off a yearly or biyearly Pro and Pro+ subscription, unlocking even more valuable investment information.
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