Money Chance: ARQT ' s New Drug Application of Psoriasis, Skin disease/disorder 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:
ARQ-154 topical roflumilast foam 0.3% for Psoriasis, Skin disease/disorder,from ARQT,PDUFA date is May 22 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 Psoriasis, Skin disease/disorder
Psoriasis is a chronic autoimmune condition that causes rapid skin cell turnover, leading to thick, scaly patches on the skin. The diagnosis of psoriasis involves a healthcare provider evaluating several factors. The appearance of the skin is crucial, with psoriasis typically presenting as red, raised, and scaly patches, often on the elbows, knees, and scalp. Itchiness is a common symptom, along with inflammation and swelling. A healthcare provider may also consider comorbidities such as psoriatic arthritis, heart disease, and depression, which can be associated with psoriasis. In some cases, a skin biopsy may be performed to confirm the diagnosis.

About ARQ-154 topical roflumilast foam 0.3%
Topical roflumilast foam (ARQ-154) is a promising treatment for inflammatory dermatoses, particularly psoriasis in hair-bearing areas like the scalp. Developed by Arcutis, it is a foam formulation of roflumilast, a potent and selective PDE4 inhibitor. PDE4 is an enzyme that regulates inflammatory mediators, making it a key target in treating inflammatory diseases such as psoriasis and atopic dermatitis. Arcutis' pivotal Phase 3 study, ARRECTOR, demonstrated significant improvements in both scalp and body psoriasis. At week 8, 67.3% of individuals treated with roflumilast foam achieved clear or almost clear skin compared to 28.1% using a vehicle. This formulation is unique, containing an emollient, water-based foam without fragrances or alcohol, designed to deliver the active drug efficiently.

About Arcutis(ARQT)
**About ARQT Search results are limited to pharmaceutical companies**

Arcutis Biotherapeutics (ARQT) reported significant financial growth in 2024, with product revenue in the fourth quarter reaching approximately $63 million, a 366% increase from the same period in 2023. The full-year 2024 product revenue is anticipated to be around $160 million, marking a 449% growth from the previous year. This robust growth was driven by strong demand for all ZORYVE® (roflumilast) indications, maintaining similar gross-to-net (GTN) levels. As of December 31, 2024, the company's liquidity stood at approximately $329 million, with $100 million of long-term debt repaid and an option to re-draw $100 million by the first half of 2026.