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Biotech Stocks Facing FDA Decision In August 2020

Roche
Roche

Novartis and Roche's Xolair, which received its first FDA approval in 2003 for allergic asthma, awaits the regulatory decision for yet another indication this quarter, i.e., for the treatment of nasal polyps in adult patients 18 years of age and older with inadequate response to intranasal corticosteroids.

Nasal polyps, a common and potentially debilitating condition in adults, present itself as noncancerous lesions on the lining of the nasal sinuses or nasal cavity and is associated with irritation and inflammation, which can block normal airflow.

An estimated 13 million people in the U.S. are impacted by nasal polyps. There are currently few treatment options available, and many patients are opting for nasal surgery or systemic steroids, which are also not able to adequately control symptoms over time due to regrowth of nasal polyps.

If approved, Xolair would become the first antibody to help reduce the size of nasal polyps and help improve symptoms.

Last year, the drug brought in annual sales of $1.17 billion for Novartis and CHF 1.97 billion for Roche.

RHHBY.OB closed Friday’s (Jul.24, 2020) trading at $42.95, down 2.45%.