Adma Biologics, Inc. has just received approval from the U.S. Food and Drug Administration (FDA) for its innovative yield enhancement production process. This milestone marks a significant achievement for the company and is expected to drive revenue growth and margin expansion.
The approved process has shown the ability to increase production yields by approximately 20% from the same starting plasma volume. This enhancement is anticipated to benefit both Asceniv and Bivigam, two of the company's products.
Adam Grossman, the President and CEO of Adma, expressed that this approval is a pivotal milestone for the company, unlocking the opportunity for meaningful acceleration in revenue and earnings trajectory. He highlighted the company's leadership in modernizing and advancing plasma fractionation through agile, forward-thinking scientific development and execution.
The FDA approval is expected to lead to a substantial increase in peak production output capacity. Adma is looking ahead to further optimize production capabilities and progress novel pipeline programs, notably SG-001, a pre-clinical, investigative hyperimmune globulin targeting S. pneumonia.
Adma Biologics, Inc. is a U.S.-based commercial biopharmaceutical company dedicated to manufacturing, marketing, and developing specialty biologics for the treatment of immunodeficient patients at risk for infection and others at risk for certain infectious diseases. The company currently manufactures and markets three FDA-approved plasma-derived biologics for the treatment of immune deficiencies and the prevention of certain infectious diseases.
This FDA approval sets the stage for Adma to capitalize on growth opportunities and expand its product offerings, ultimately driving its position in the biopharmaceutical industry. The market has reacted to these announcements by moving the company's shares 11.8% to a price of $24.44. For the full picture, make sure to review ADMA Biologics's 8-K report.
