Money Chance: MRK ' s New Drug Application of Pheochromocytoma , Paraganglioma 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:
WELIREG(belzutifan) for Pheochromocytoma , Paraganglioma,from MRK,PDUFA date is May 26 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 Pheochromocytoma , Paraganglioma
Pheochromocytoma and Paraganglioma (PPGL) are rare tumors that can lead to various symptoms, including high blood pressure, sweating, and anxiety. Diagnosis involves biochemical tests, such as measuring plasma metanephrine or 24-hour urine fractionated metanephrine levels, as recommended by the Endocrine Society. These tests are sensitive but can be affected by various factors, including improper urine collection and patient position. The choice between serum and urine tests depends on the patient's age and compliance, with serum tests often being more convenient.

About WELIREG(belzutifan)
WELIREG is a prescription medication used to treat adults with von Hippel-Lindau (VHL) disease, specifically for certain types of kidney cancer, brain and spinal cord tumors, and pancreatic neuroendocrine tumors that do not require immediate surgery. It is also used to treat advanced kidney cancer that has spread after treatment with PD-1 or PD-L1 and VEGF cancer medicines. WELIREG is not known to be safe and effective in children, and it may cause serious side effects, including low red blood cell counts (anemia) and low oxygen levels in the body. These side effects can be severe and may require medical intervention. Additionally, WELIREG may harm an unborn baby.

About Merck(MRK)
Merck, known as MSD outside of the U.S. and Canada, is a global leader in the biopharmaceutical industry, with a strong focus on research and innovation. The company, listed on the New York Stock Exchange under the symbol 'MRK,' is dedicated to improving lives through the development of medicines and vaccines. With approximately 75,000 employees worldwide, Merck fosters a diverse and inclusive global workforce. Headquartered in Rahway, New Jersey, Merck operates responsibly, aiming to create a safe, sustainable, and healthy future for all communities.