Money Chance: BIIB ' s New Drug Application of Alzheimer's disease 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:
Leqembi (Lecanemab) IV Maintenance Dosing for Alzheimer's disease,from BIIB,PDUFA date is January 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 Alzheimer's disease
Alzheimer's disease (AD), named after Alois Alzheimer who first described it in 1906, is a progressive neurodegenerative disorder characterized by the presence of neuritic plaques and neurofibrillary tangles in the brain. These abnormalities are caused by the accumulation of amyloid-beta peptides in the medial temporal lobe and neocortical structures. AD is the most common form of dementia, with around 50 million patients worldwide and projected numbers expected to double every 5 years.

Diagnosing AD can be challenging, as it involves a combination of clinical evaluation, laboratory tests, and imaging studies. The National Institute of Neurological and Communicative Disorders and Stroke (NINCDS) and the Alzheimer's Disease and Related Disorders Association (ADRDA) established diagnostic criteria in 1984, which include probable, possible, and definite AD. Probable AD is diagnosed based on clinical symptoms, while possible AD is diagnosed in the presence of other illnesses that may be contributing to the dementia. Definite AD requires histopathologic confirmation from a biopsy or autopsy.

In 2011, the National Institute on Aging and the Alzheimer's Association updated the diagnostic criteria to include probable and possible AD dementia for clinical use and probable or possible AD dementia with pathophysiological evidence for research purposes. Additionally, they identified two categories of AD biomarkers: markers of brain amyloid, such as positron emission tomography (PET) and cerebrospinal fluid (CSF), and markers of neuronal injury, such as CSF tau, fluorodeoxyglucose (FDG) for metabolic activity, and magnetic resonance imaging (MRI) for atrophy measurement.

Despite the availability of diagnostic criteria and biomarkers, there is still no cure for AD. Current treatments only improve symptoms and include acetylcholinesterase inhibitors and NMDA receptor antagonists. Recent research has focused on developing compounds that target various pathogenic mechanisms, such as Aβ and tau aggregation, misfolding, inflammation, oxidative damage, and others.

About Leqembi (Lecanemab) IV Maintenance Dosing
Leqembi (lecanemab), a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody developed through a collaboration between Eisai and BioArctic, is approved in several countries, including the United States, Japan, China, and South Korea, for the treatment or management of Alzheimer's disease (AD). The drug is indicated for patients with mild cognitive impairment (MCI) or mild dementia stage of disease in the United States and Japan. In China and South Korea, it is used for treating MCI due to AD and mild AD dementia, respectively.

However, it appears that information on the maintenance dosing of Lequembi is limited in search results, which are primarily focused on the drug's name. It is essential to consult the full prescribing information for Lequembi to obtain the most accurate and up-to-date information on dosing, administration, and potential side effects.

It is worth noting that Lequembi carries a Boxed Warning for Amyloid-Related Imaging Abnormalities (ARIA), which can occur early in treatment and may be asymptomatic or serious. Patients who are ApoE ε4 homozygotes have a higher incidence of ARIA compared to heterozygotes and noncarriers. Prescribers should discuss the risks of ARIA and the implications of genetic testing results with patients before initiating treatment.

About Biogen(BIIB)
Ji Xing Pharmaceuticals' recent acquisition of Biogen's investigational drug, BIIB 131, has expanded the company's pipeline and global reach in treating acute ischemic stroke (AIS). The drug's potential to restore blood flow and improve patient outcomes, even beyond existing treatment windows, has generated excitement in the pharmaceutical industry.

BIIB 131's mechanism of action combines thrombolytic and anti-inflammatory properties, making it a promising breakthrough for AIS patients who have not seen significant pharmacologic innovation in nearly three decades. The positive results from a Phase II trial in Japan, where subjects treated with BIIB 131 demonstrated better clinical outcomes at 90 days than those given a placebo, further support its potential.

The acquisition's terms include an undisclosed upfront payment, milestone payments, and royalty payments on worldwide product sales. Ji Xing's CEO, Sandy Mou, expressed optimism about the acquisition, stating that it would not only enrich the company's pipeline but also accelerate its globalization strategy.

In addition to the acquisition, Ji Xing has entered a strategic partnership with TMS to develop TMS-007, another new treatment for AIS. This collaboration will see TMS retain royalty-free rights in Japan, while Ji Xing spearheads its development and commercialization in other countries.

Understanding the competitive landscape is crucial for any business, and the pharmaceutical industry is no exception. With the acquisition of BIIB 131 and the strategic partnership with TMS, Ji Xing Pharmaceuticals has positioned itself as a key player in the global AIS treatment market.