Money Chance: SCPH ' s New Drug Application of Heart failure to be Decided by FDA soon

Generated by AI AgentFDA Tracker
Sunday, Aug 25, 2024 9:01 pm ET2min read
SCPH--

Summary:
This week, FDA would give a NDA (New Drug Application) result, which means a large potential market movements for investors:
FUROSCIX (furosemide) for Heart failure,from SCPH,PDUFA date is August 31 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 Heart failure
Heart failure is a significant health concern in the United States, affecting nearly 6.7 million adults over the age of 20. This condition, often referred to as congestive heart failure, occurs when the heart is unable to pump an adequate amount of blood and oxygen to support other organs in the body. While there is a wealth of information available on the topic, search results are often limited to symptoms and disease names. This can make it challenging for individuals to fully understand the underlying causes and implications of heart failure, as well as the various treatment options available.

About FUROSCIX (furosemide)
FUROSCIX (furosemide) is a loop diuretic medication that is commonly used to treat various conditions such as edema, hypertension, and heart failure. The drug is available in different forms, including a single-dose prefilled cartridge co-packaged with a single-use, on-body infusor. However, searching for information about FUROSCIX online may yield limited results, as most search results are focused on the drug name rather than the specific product.

Despite its limited online presence, FUROSCIX has undergone extensive nonclinical testing to ensure its safety and efficacy. In animal studies, there was a small but significant increase in mammary gland carcinomas in female mice and marginal increases in uncommon tumors in male rats at certain doses. However, these findings were not observed at higher doses. The drug is chemically known as 4chloroNfurfuryl5sulfamoylanthranilic acid and is a white to slightly yellow crystalline powder.

FUROSCIX is administered via a wearable, single-use, electromechanical on-body delivery system that delivers 80 mg of the drug over 5 hours using a bi-phasic delivery profile. Patients are advised to follow the instructions provided with the medication carefully to ensure safe and effective use.

About Scpharmaceuticals(SCPH)
The search results for 'SCPH' on the stock market database SCPHarmaceuticals Inc. (SCPH) are predominantly limited to pharmaceutical companies. This is because SCPH is a NASDAQ-listed biopharmaceutical company that specializes in the research, development, and commercialization of therapeutics. The company's market capitalization of $268.65 million and net income loss of $-60.64 million reflect its focus on pharmaceutical innovation. Although SCPH's stock performance may be of interest to a broader audience, the primary search results on the stock market database are tailored to the pharmaceutical industry.

The PDUFA date and ADCOM dates are when the FDA decides on new drug applications and when the Advisory Committee provides voting results. Vital role of FDA in approving/rejecting US market drugs impacts the stock market significantly through both outcomes.

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