Money Chance: MRNA ' s New Drug Application of Respiratory syncytial virus to be Decided by FDA soon

Summary:
This week, FDA would give a NDA (New Drug Application) result, which means a large potential market movements for investors:
mRESVIA (mRNA-1345) for Respiratory syncytial virus,from MRNA,PDUFA date is June 12 2025.

Why should focus PDUFA Date:
The PDUFA (Prescription Drug User Fee Act) is a critical regulatory milestone in the drug development process. It refers to the date by which the FDA (Food and Drug Administration) is expected to make a decision on a new drug application. As the pharmaceutical industry is highly regulated, the FDA plays a crucial role in approving or rejecting drugs that can be marketed in the United States.
When a PDUFA date is approaching, it creates an investment opportunity for traders and investors to capitalize on the potential market movements related to the FDA's decision on drug approvals or rejections. Typically, a positive outcome can lead to an increase in the stock price of the pharmaceutical company, while a negative outcome can lead to a decline in the stock price.

About Respiratory syncytial virus
The systematic literature review of Respiratory Syncytial Virus (RSV) symptoms reveals a lack of comprehensive data on symptom presentation across at-risk groups. The studies focused on children aged ≤5 years and immunocompromised adults, reporting nasal discharge/congestion, cough, shortness of breath, feeding abnormalities, and fever as common symptoms. The duration of symptoms and hospital stays varied significantly, with children's median hospital stays ranging from 2 to 7.5 days and adults' ranging from 6 to 15 days. The review highlights the need for more detailed studies on RSV symptoms in diverse populations to improve clinical management and public health strategies.

About mRESVIA (mRNA-1345)
The approval of mRESVIA (mRNA-1345) by the FDA marks a significant milestone in the development of RSV mRNA vaccines. This single-dose prefilled syringe vaccine is designed to prevent RSV-induced lower respiratory tract diseases (RSV-LRTD) in adults aged 60 and above. The vaccine, which uses the same lipid nanoparticle (LNP) technology as Moderna's COVID-19 vaccine, has shown high efficacy and good safety profiles in clinical trials. The approval comes after a rigorous process involving concept validation, clinical trials, and regulatory reviews. This approval positions Moderna's RSV vaccine to compete with other RSV vaccines from GlaxoSmithKline and Pfizer, which were introduced in the previous autumn. The success of mRESVIA underscores the potential of mRNA technology in combating respiratory infections.

About Moderna(MRNA)
The article by Xie et al. (2021) discusses the evolution of the mRNA technology market, highlighting its rapid growth and commercial success. The authors note that the market capitalization of RNA-based pharmaceutical companies has significantly increased, with mRNA vaccines leading the way. However, the search results for mRNA technology are limited to pharmaceutical companies, excluding diversified companies like Merck, Pfizer, and Sanofi. This limitation is due to the specific focus on companies specializing in RNA technology, as indicated by the search terms used in the meta-analysis. The article also mentions that financial data for public companies supporting the meta-analysis is available at Yahoo Finance, but access to more detailed and proprietary data may require contacting the data providers directly.