ADMA - ADMA Bio shares surge 23% on FDA approval for increased IVIG production scale

ADMA Biologics (ADMA) soars 23% premarket after the FDA has granted approval for its expanded manufacturing process, enabling fractionation and purification of a 4,400-liter plasma pool for the manufacture of Intravenous Immune Globulin ((IVIG)). The 4,400-liter IVIG plasma pool scale for BIVIGAM will allow ADMA to expand its total processing capacity from 400,000 liters to an anticipated peak throughput of up to 600,000 liters.“The expanded plasma pool production scale allows us to confidently commit to generating peak revenues in excess of $300 million and this approval solidifies the pathway to meaningful gross margin expansion beginning potentially in the second half of 2021 and accelerating throughout 2022," said Adam Grossman, President and CEO.In addition, the Company is reiterating its expectation for QoQ revenue growth throughout 2021 and beyond.With this approval, ADMA additionally will now be able to offer BIVIGAM in two vial sizes, both the 50 mL and 100 mL configurations.

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ADMA Bio shares surge 23% on FDA approval for increased IVIG production scale