Money Chance: THTX ' s New Drug Application of Human immunodeficiency virus, Abdominal Fat 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:
Tesamorelin (F8 Formulation) for Human immunodeficiency virus, Abdominal Fat,from THTX,PDUFA date is March 25 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, Abdominal Fat
Human immunodeficiency virus (HIV) infection is associated with changes in fat distribution, leading to obesity, lipohypertrophy, and insulin resistance (Lake et al., 2017). Several studies have investigated the underlying mechanisms and potential interventions for these metabolic abnormalities. For instance, metformin therapy has shown benefits in reducing markers of cardiovascular risk in HIV-infected patients with fat redistribution and insulin resistance (Hadigan et al., 2002).

Moreover, HIV-infected individuals often experience changes in abdominal fat following antiretroviral therapy initiation, which can correlate with waist circumference and self-reported changes (Bhagwat et al., 2017). Risk factors for severe weight gain include traditional factors such as age, sex, and genetics, as well as HIV-specific factors such as antiretroviral therapy regimens (Bhagwat et al., 2017; Bourgi et al., 2019; Lake et al., 2019).

The relationship between fat distribution and adipokines, such as adiponectin, in HIV infection has also been studied. Adiponectin is a negative regulator of antigen-activated T cells and has been shown to regulate immune responses in chronic hepatitis C virus infection (Wilk et al., 2011; Palmer et al., 2008). Circulating sex hormones and gene expression of subcutaneous adipose tissue oestrogen and alpha-adrenergic receptors have also been implicated in fat distribution in HIV-lipodystrophy (Andersen et al., 2007; Pedersen et al., 2004).

In summary, HIV infection is associated with metabolic abnormalities, including changes in fat distribution, obesity, lipohypertrophy, and insulin resistance. Several studies have investigated the underlying mechanisms and potential interventions for these metabolic abnormalities, including metformin therapy, lifestyle modification, and adipokine regulation.

About Tesamorelin (F8 Formulation)
The F8 formulation of tesamorelin, a drug used for the reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy, has recently been developed by Theratechnologies. Pharmacokinetic studies have demonstrated bioequivalence of the F8 formulation to the original F1 formulation of tesamorelin, but it is eight times more concentrated and two times more concentrated than the F4 formulation currently available in the US. This higher concentration enables a smaller volume of administration and a new product presentation in a multiple-dose vial that is reconstituted only once per week. The new formulation is also patent protected in the US until 2033.

The development of the F8 formulation addresses the growing concern of HIV healthcare providers regarding the clinical challenges of excess abdominal fat and its negative health consequences for their patients. The FDA is currently reviewing Theratechnologies' sBLA application for the F8 formulation, and the company expects to receive an acknowledgement letter within 30 days along with a PDUFA goal date. The proposed proprietary name for the F8 formulation, EGRIFTA MDV TM, is already under review by the FDA.

It is important to note that the long-term cardiovascular safety of EGRIFTA SV, the current formulation of tesamorelin, has not been established, and the use of EGRIFTA SV is not indicated for weight loss management as it has a weight neutral effect. There are also no data to support improved compliance with anti-retroviral therapies in HIV-positive patients taking EGRIFTA SV.

About Theratechnologies(THTX)
The paragraph below focuses on the question of 'About THTX Search results are limited to pharmaceutical companies':

Theratechnologies (TH) and Ionis Pharmaceuticals (Ionis) are two prominent biopharmaceutical companies with distinct areas of focus. While Theratechnologies is primarily known for its work in HIV treatments, its recent agreement with Ionis expands its portfolio to include investigational RNA-targeted medicines for familial chylomicronemia syndrome (FCS), severe hypertriglyceridemia (sHTG), and hereditary angioedema (HAE). The search results for these companies on various platforms, including their respective websites, Securities and Exchange Commission (SEC) filings, and social media channels, are not limited to pharmaceutical companies alone. Instead, they provide comprehensive information on the companies' research and development pipelines, market opportunities, financial performance, and regulatory milestones.

Both Theratechnologies and Ionis have a strong presence on social media platforms like LinkedIn, Twitter, and Instagram, where they share updates on their research, clinical trials, and regulatory progress. Additionally, their SEC filings, available on SEDAR+ and EDGAR, provide detailed information on their financial performance, management, and business operations.

In summary, while Theratechnologies and Ionis are primarily pharmaceutical companies, their search results encompass a broader range of information, including their research and development pipelines, market opportunities, financial performance, and regulatory milestones.