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ADMA Biologics Rips Higher On FDA Nod For Immunodeficiency Therapy

Shanthi Rexaline

Microcap specialty pharma company ADMA Biologics Inc (NASDAQ: ADMA) advanced in the last two trading days in anticipation of a binary event, and with the event materializing in favor of the company, the stock has taken another leg up.

What Happened

ADMA announced Monday after the market close that the FDA approved its Asceniv, a novel, patented, intravenous immunoglobulin product for the treatment of primary humoral immunodeficiency disease, or PIDD, in adults and adolescents ages 12-17.

PIDD is a collective name for more than 300 diseases that occur due to defects in the body's immune system, invariably manifesting as acute or recurrent infections.

Asceniv is manufactured using ADMA's unique, patented plasma donor screening methodology and tailored plasma pooling design, which blends the source plasma and plasma from donors testing using its proprietary microneutralization assay.

ADMA said the approved labeling comes with a boxed warning about potential thrombosis and renal dysfunction or failure, as well as the most common adverse events observed in the pivotal study.

Why It's Important

About 250,000 PIDD patients are diagnosed in the U.S., and the approval of Asceniv presents an opportunity to treat meaningful segments of this patient population, ADMA said.

What's Next

ADMA said it expects to commercially launch the product in the second half of 2019.

At last check, ADMA shares were skyrocketing 33.42 percent to $5.43 on higher-than-average volume.  

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