Biotech Opportunities: REGN's New Drug Application of Eosinophilic Esophagitis to be Decided by FDA soon
3min read Summary:
This week, FDA would give a NDA (New Drug Application) result, which means a large potential market movements for investors:
Dupixent(dupilumab) (IL-4 IL-13) for Eosinophilic Esophagitis,from REGN,PDUFA date is January 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 FDAs 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 Eosinophilic Esophagitis
Eosinophilic esophagitis (EoE) refers to a chronic inflammatory condition characterized by the presence of elevated eosinophil levels in the esophagus. Two significant studies, one published in the American Journal of Gastroenterology in 2009 and another in the journal Dis Esophagus in 2013, provide valuable insights into the pathology and related conditions.
R.D. Odzes review in the American Journal of Gastroenterology explains the essential aspects that clinicians should understand about EoEs pathology. In the Dis Esophagus study, the researchers investigated the pattern of eosinophilic infiltration in patients with achalasia, a motor disorder of the esophagus, and the effect of treatment on these levels.
Eosinophilic esophagitis is a condition that allergists should be aware of. In a 2019 JAMA publication, Peiris and Tarbox discuss the topic, while Mehr and Brown-Whitehorn focus on non-IgE-mediated food allergies in their Annals of Allergy, Asthma & Immunology article. Both articles emphasize the significance of this condition and the need for healthcare providers to understand its symptoms and potential associations with other diseases.
Symptoms of EoE can include heartburn, difficulty swallowing, and food impaction. Diagnosis is typically through endoscopy and esophageal biopsy, revealing the presence of eosinophilic infiltration. Treatment often involves a combination of medications and dietary interventions to alleviate symptoms and reduce eosinophil levels.
Research on the subject continues to expand our knowledge about EoE and its relation to other conditions, such as achalasia, highlighting the need for both clinicians and specialists to stay updated on the latest findings in this area.
About Dupixent(dupilumab) (IL-4 IL-13)
Dupixent (dupilumab), a human monoclonal antibody, targets the interleukin-4 (IL-4) receptor alpha subunit, blocking both IL-4 and interleukin-13 (IL-13) signaling. By inhibiting IL-4 and IL-13 cytokine responses, it helps address inflammation associated with certain chronic diseases. Dupilumabs peak concentration is achieved within a week of initial subcutaneous administration at 600mg, with steady-state concentrations reached by week 16 when 300mg is given every two weeks or weekly.
The drug is primarily used to treat moderate-to-severe atopic dermatitis, asthma, and chronic rhinosinusitis with nasal polyposis (CRSwNP) in various age populations worldwide. It has been studied in over 60 clinical trials involving more than 10,000 patients, and over 300,000 patients have been treated globally.
Currently, dupilumab is being investigated for a broader range of diseases driven by type 2 inflammation, such as chronic obstructive pulmonary disease, pediatric atopic dermatitis, eosinophilic esophagitis, bullous pemphigoid, prurigo nodularis, chronic spontaneous urticaria, chronic inducible urticaria-cold, chronic rhinosinusitis without nasal polyposis, allergic fungal rhinosinusitis, allergic bronchopulmonary aspergillosis, and peanut allergy.
In the Phase 3 clinical trials LIBERTY NP SINUS-24 and LIBERTY NP SINUS-52, dupilumab showed significant and overwhelmingly positive results in treating CRSwNP when added to a standard intranasal steroid regime. The drug successfully reduced nasal polyp scores and nasal obstruction and demonstrated improvement across various secondary endpoints.
About Regeneron(REGN)
The REGN search results are predominantly focused on pharmaceutical companies due to the specific entity in question being Regeneron Pharmaceuticals, Inc. Regeneron is a prominent biotechnology company known for discovering, inventing, developing, manufacturing, and commercializing innovative medicines to treat various diseases worldwide.
Their product line includes treatments for ophthalmic conditions, atopic dermatitis, asthma, skin cancer, and high cholesterol levels, as well as an injection for covid-19 and an Ebola infection treatment. The company is actively developing potential cures for a wide range of diseases, including eye, allergic and inflammatory, cardiovascular and metabolic, infectious, and rare diseases, as well as cancer, pain, and hematologic conditions.
As of the Fortune 500 ranking in 2023, Regeneron Pharmaceuticals holds the 339th position, showcasing its significant impact and contribution to the United States economy. The company reported revenues of $12,173 million, profits of $4,338 million, and a market value of $68,249 million. This data highlights Regenerons strong financial position and its role in shaping the pharmaceutical industry.