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CAMBRIDGE, MA - Moderna, Inc. (NASDAQ:MRNA), currently valued at $10.82 billion, revealed today that it has voluntarily withdrawn its application for mRNA-1083, a proposed flu/COVID combination vaccine for adults over 50. The decision was made in consultation with the U.S. Food and Drug Administration (FDA) and follows the company’s strategy to incorporate forthcoming efficacy data from a separate vaccine trial. According to InvestingPro data, the company maintains strong liquidity with a current ratio of 4.22, though analysts have recently revised earnings expectations downward.
The biotechnology firm, known for its rapid development of mRNA medicines, including a COVID-19 vaccine, stated that it plans to resubmit the Biologics License Application (BLA) for mRNA-1083 later in the year. This resubmission will be bolstered by results from the ongoing Phase 3 trial of mRNA-1010, Moderna’s investigational seasonal influenza vaccine. Interim data from the mRNA-1010 trial are expected to be available this summer, which will inform the BLA for the combination vaccine.
This announcement comes as a strategic pivot for Moderna, which has been at the forefront of mRNA technology, creating therapies and vaccines for various diseases. The company emphasizes its commitment to transforming medicine and preventing disease through its mRNA platform, which has been a significant contributor to its success in the pharmaceutical industry. InvestingPro analysis indicates the stock is currently undervalued, though it faces challenges with revenue declining 38.35% over the last twelve months.
The press release from Moderna also contains forward-looking statements that outline the company’s expectations and plans for the future. These statements, however, are subject to risks, uncertainties, and other factors that could cause actual results to differ from those projected. The company has directed interested parties to its filings with the U.S. Securities and Exchange Commission for more information on these risk factors.
The news of the withdrawal is based on a press release statement from Moderna and does not reflect any promotional content. The company’s stock market information, including its NASDAQ ticker symbol MRNA, provides a context for investors monitoring the company’s developments. As Moderna continues to navigate the regulatory landscape and advance its vaccine portfolio, the healthcare community and investors await the results of the ongoing trials with anticipation.
In other recent news, Moderna Inc. reported its first-quarter 2025 financial results, revealing a narrower-than-expected loss but a decline in revenue. The company posted an earnings per share (EPS) of -$2.52, surpassing the anticipated -$3.18, while revenue came in at $108 million, falling short of the $115.3 million forecast. Moderna’s management highlighted significant cost reductions, which contributed to improved financial stability. Berenberg reaffirmed its Hold rating on Moderna, maintaining a $30 price target, and noted the company’s effective cost management amidst commercial challenges. The U.S. Food and Drug Administration (FDA) plans to require new clinical trials for annual COVID-19 boosters for healthy individuals under 65, potentially impacting vaccine manufacturers like Moderna. Additionally, the Department of Health and Human Services (HHS) is set to discontinue routine COVID-19 vaccine recommendations for certain groups, which could affect vaccine producers, including Moderna. These developments come as Moderna focuses on advancing its vaccine and oncology pipelines, aiming for future growth through upcoming product launches and regulatory approvals.
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