Money Chance: VNDA ' s New Drug Application of Gastroparesis 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:
Tradipitant for Gastroparesis,from VNDA,PDUFA date is September 18 2024.

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 Gastroparesis
Gastroparesis is a complex and often misunderstood condition that affects the stomach's ability to empty food properly, leading to a range of symptoms including nausea, vomiting, abdominal pain, early satiety, and bloating. Despite advances in understanding its causes and potential treatments, many myths and misconceptions persist regarding this disorder.

One common myth is that search results for gastroparesis are limited to symptoms and disease names. However, recent research has provided new insights into the underlying mechanisms of gastroparesis, including its pathophysiology, diagnosis, and treatment. A review of the latest studies on gastroparesis aims to dispel this myth by identifying the most prevalent myths and misconceptions surrounding this condition and providing evidence-based information to help advance clinical management.

Gastroparesis affects millions of people worldwide, and its impact on patients' quality of life can be significant. The condition can lead to chronic abdominal pain, malnutrition, and dehydration, and it can also result in increased healthcare costs and utilization. As a result, there is a pressing need to better understand gastroparesis and to develop more effective treatments to improve patients' outcomes and reduce the burden on the healthcare system.

The current understanding of gastroparesis is evolving rapidly, with new research shedding light on its underlying causes, including diabetes, viral infections, and certain medications. There is also growing interest in developing new treatments, including neuromodulation, probiotics, and dietary modifications, to help manage the symptoms of gastroparesis and improve patients' quality of life.

Despite these advances, many myths and misconceptions about gastroparesis persist, including the idea that it is a rare or unimportant condition, that its symptoms are simply a normal part of aging, and that there is no effective treatment. By debunking these myths and providing accurate and up-to-date information on gastroparesis, this review aims to help advance the field and ultimately improve the lives of people living with this challenging and often misunderstood condition.

About Tradipitant
Tradipitant, an NK-1R antagonist licensed by Vanda from Eli Lilly and Company, is currently under clinical development for the treatment of gastroparesis and motion sickness. With a prevalence of approximately 6 million patients in the United States and limited treatment options available, gastroparesis represents a significant unmet medical need. The only FDA-approved treatment for gastroparesis, metoclopramide, has been available since 1979 and carries a black box warning due to potential severe side effects, limiting its use to no more than 3 months.

Recently, Vanda submitted an NDA for Tradipitant to the FDA, which included results from clinical efficacy studies 2301 and 3301, evidence from a large 12-week open label study, and data from the Expanded Access program. The safety database in this application now under review includes over 1,000 patients with exposures of up to 12 weeks and data from the Expanded Access program with patient exposures of over two years. Mihael H. Polymeropoulos, Vanda's President, CEO, and Chairman of the Board, expressed optimism about the FDA's acknowledgment of the completeness of the application and anticipates a substantive review.

Notably, the FDA's acceptance of this application for filing without requiring a nine-month dog study, which is typically required for NDA submissions, indicates the agency's recognition of advanced human-relevant microphysiological systems as a viable alternative. If approved, Tradipitant will be the first novel drug for patients with gastroparesis since 1979 and will significantly improve the lives of those affected by this serious condition.

About Vanda Pharmaceuticals(VNDA)
Vanda Pharmaceuticals Inc. (VNDA) is a publicly-traded pharmaceutical company listed on the Nasdaq stock exchange. As of September 13, 2024, VNDA's stock price was $5.10, up by 2.20% from the previous day's closing price. The company does not currently pay dividends and has not announced an ex-dividend date. With a high volume of 492,030 shares traded on this day, VNDA is an active player in the pharmaceutical industry.

It is important to note that VNDA Search results are limited to pharmaceutical companies, which means that other types of organizations or businesses are not included in the search results. This focus on the pharmaceutical sector is likely due to the specific nature of the VNDA database and its emphasis on providing information related to this industry.