Primary humoral immunodeficiency (PI)

Stage (next event)

Next Event

Expected Date


Quarterly Sales

March 05, 2021 (Est)

Achieved Fourth Quarter 2020 Preliminary Unaudited Total Revenues of $13.9 Million, the Highest Revenue Quarter for the Company Since Inception

Catalyst Info & Data Links


  • FDA Label

  • Centers for Medicare and Medicaid Services (CMS) has approved transitional pass-through payment status and established a new reimbursement C-code, C9072, for ASCENIV which is effective January 1, 2021.

  • Achieved Fourth Quarter 2020 Preliminary Unaudited Total Revenues of $13.9 Million, the Highest Revenue Quarter for the Company Since Inception


Mechanism of Action

ASCENIV is a replacement therapy for patients with primary humoral immunodeficiency (PI) (e.g. agammaglobulinemia, hypogammaglobulinemia, CVID, SCID). The broad spectrum of neutralizing IgG antibodies against bacterial and viral pathogens and their toxins helps to avoid recurrent serious opportunistic infections. IgG antibodies are opsonins that increase phagocytosis and elimination of pathogens from the circulation. The mechanism of action has not been fully elucidated in PI.


  • PI is a class of inherited genetic disorders that causes an individual to have a deficient or absent immune system.  According to the World Health Organization, there are approximately 350 different genetic mutations encompassing PI. Some disorders present at birth or in early childhood, the disorders can affect anyone regardless of age or gender. Some affect a single part of the immune system, others may affect one or more components of the system. PI patients are vulnerable to infections and more likely to suffer complications from these infections as compared to individuals with a normal functioning immune system. The infections may occur in any part of the body. Because patients suffering from PI lack a properly functioning immune system, they typically receive monthly treatment with polyclonal immune globulin products. Without this exogenous antibody replacement, these patients would remain vulnerable to persistent and chronic infections. PI has an estimated prevalence of 1:1,200 in the United States, or approximately 250,000 people in the U.S.


Prior Data (click to view full image)


Trial Design / Revenue (click to view full image)


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