Money Chance: MRK ' s New Drug Application of Head and neck squamous cell carcinoma, Cancer 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:
KEYTRUDA(pembrolizumab) for Head and neck squamous cell carcinoma, Cancer,from MRK,PDUFA date is June 23 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 Head and neck squamous cell carcinoma, Cancer
Head and neck squamous cell carcinoma (HNSCC) is a type of cancer that primarily affects the head and neck region, including the oral cavity, pharynx, and larynx. It is often associated with risk factors such as tobacco and alcohol use, as well as human papillomavirus (HPV) infection. KEYTRUDA, an anti-programmed death receptor-1 (PD-1) therapy, is indicated for various stages of HNSCC. It can be used as a single agent for neoadjuvant treatment in resectable locally advanced HNSCC, and as adjuvant treatment in combination with radiotherapy. KEYTRUDA is also indicated for first-line treatment of metastatic or unresectable, recurrent HNSCC, both with and without PD-L1 expression. Additionally, it is used for patients with recurrent or metastatic HNSCC who have progressed on or after platinum-containing chemotherapy. Merck's extensive clinical research program for KEYTRUDA aims to understand its role in different cancers and identify predictive biomarkers.

About KEYTRUDA(pembrolizumab)
KEYTRUDA (pembrolizumab) is an anti-PD-1 therapy developed by Merck. It has been granted FDA approval for the treatment of adult patients with resectable locally advanced head and neck squamous cell carcinoma (HNSCC) whose tumors express PD-L1 (Combined Positive Score [CPS] ≥1). The approval was based on the Phase 3 KEYNOTE-689 trial, which demonstrated a 30% reduction in the risk of recurrence and progression compared to standard of care. However, the study did not show an improvement in overall survival for patients with low to zero levels of PD-L1. In contrast, CEL-SCI’s Phase 3 study showed that Multikine treated patients with low to zero levels of PD-L1 had their risk of death reduced by 66% and extended their 5-year overall survival to 73%.

About Merck(MRK)
Merck & Co. Inc. (NYSE:MRK), often referred to as Merck, has recently seen its stock price increase by 1.86% due to two significant developments. The first is the success of enlicitide decanoate, a cholesterol medication, which achieved its primary endpoint in two late-stage clinical trials. This medication is being studied as a potential treatment for hyperlipidemia, a condition characterized by high cholesterol levels. The second notable event is the U.S. Food and Drug Administration (FDA) approval of Merck's RSV antibody shot for infants. This shot protects infants up to one year old from respiratory syncytial virus (RSV) during their first RSV period. Despite these positive developments, a recent comparison between Merck and Johnson & Johnson (JNJ) suggests that JNJ may offer better growth prospects due to its stronger 2025 growth prospects, broader pipeline, and better sales momentum.