Money Chance: GILD ' s New Drug Application of Human immunodeficiency virus to be Decided by FDA soon

Generated by AI AgentFDA Tracker
Sunday, Jun 15, 2025 9:05 pm ET1min read

Summary:
This week, FDA would give a NDA (New Drug Application) result, which means a large potential market movements for investors:
Lenacapavir for Human immunodeficiency virus,from

,PDUFA date is June 19 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 Human immunodeficiency virus
The human immunodeficiency virus (HIV) is a lentivirus that causes acquired immunodeficiency syndrome (AIDS) by attacking the immune system. HIV is primarily transmitted through unprotected sexual contact, sharing contaminated needles, and from mother to child during pregnancy, delivery, or breastfeeding. The virus targets CD4+ T cells, which are crucial for the immune system's function. Symptoms of HIV infection can include fever, swollen lymph nodes, and fatigue, but many people may not experience symptoms for years. HIV treatment involves antiretroviral therapy (ART), which can reduce the viral load to undetectable levels and prevent progression to AIDS. The World Health Organization (WHO) and other global health organizations work to combat HIV through prevention, treatment, and care programs, aiming to achieve the goal of ending AIDS by 2030.

About Lenacapavir
Lenacapavir, a compound with the molecular formula C39H32ClF10N7O5S2 and CID 133082658, is listed on PubChem. However, the search results are limited to the drug name, as the PubChem website requires JavaScript to be enabled for full functionality. This limitation may restrict access to detailed chemical and biological information about Lenacapavir.

About Gilead Sciences(GILD)
Gilead Sciences, Inc. (GILD), a biopharmaceutical company with a market cap of $143.8 billion, is a leader in the drug manufacturing industry, particularly known for its HIV and hepatitis C therapies. Despite its size and influence, GILD's search results on various platforms may be limited to pharmaceutical companies due to the specialized nature of its business. This focus on pharmaceuticals means that searches for GILD might not yield results from other industries, such as technology or consumer goods.

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