CAMBRIDGE, MA - The U.S. Food and Drug Administration (FDA) has notified biotechnology company Moderna , Inc. (NASDAQ:MRNA) that it will not meet the May 12, 2024, deadline to complete the review of the Biologics License Application (BLA) for mRNA-1345, Moderna's candidate vaccine against respiratory syncytial virus (RSV). The FDA cites administrative constraints as the reason for the delay and expects to finalize the review by the end of May 2024.
According to the press release issued by Moderna on Friday, the FDA has not raised any concerns regarding the vaccine's safety, efficacy, or quality that would prevent its approval. The company's President, Stephen Hoge, M.D., expressed gratitude for the FDA's ongoing efforts and stated Moderna's readiness to assist in completing the application review.
Moderna's mRNA-1345 vaccine is also scheduled to be reviewed at the Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) meeting on June 26-27, 2024. This review is a necessary step before the vaccine can be commercially launched.
Moderna, known for its role in developing one of the earliest and most effective COVID-19 vaccines, specializes in mRNA technology, which has been pivotal in creating vaccines and therapeutics for various diseases, including infectious diseases, immuno-oncology, rare diseases, and autoimmune diseases. The company remains committed to its mission of transforming how medicines are made and how diseases are treated and prevented.
The information in this article is based on a press release statement from Moderna, Inc.
InvestingPro Insights
As Moderna, Inc. (NASDAQ:MRNA) navigates the regulatory process for its RSV vaccine candidate, investors are closely monitoring the company's financial health and stock performance. An InvestingPro analysis reveals that Moderna's management has been actively buying back shares, a move that can signal confidence in the company's future prospects. Moreover, Moderna holds more cash than debt on its balance sheet, providing a cushion for continued investment in research and development.
InvestingPro Data highlights that Moderna's stock price has experienced strong returns over different periods, including the last month and three months, indicating positive investor sentiment. Still, it is important to note that analysts are expecting a sales decline in the current year and do not anticipate the company will be profitable this year. Despite this, Moderna's liquid assets exceed its short-term obligations, suggesting financial stability in the near term.
For those interested in a deeper dive into Moderna's financials and future outlook, there are additional InvestingPro Tips available. For instance, analysts have revised their earnings upwards for the upcoming period, and while the company does not pay a dividend, its strong return over the last five years could be of interest to growth-oriented investors. To explore all 15 InvestingPro Tips, which could provide valuable insights into investment decisions, visit https://www.investing.com/pro/MRNA. Don't forget to use the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription.
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