FDA Approves ADMA Biologics' Yield Enhancement Process

By Bobby Samwell • Monday, April 28 15:14 • Permanent Link

ADMA Biologics, Inc. has announced a significant development with the approval of an innovative production yield enhancement process by the U.S. FDA. This approval is expected to have a substantial impact on the company's revenue growth, margin expansion, and production capacity.

The new process is anticipated to result in approximately a 20% increase in production output from the same starting plasma volume. This enhancement is set to benefit both Asceniv and Bivigam, two of ADMA's key products.

Adam Grossman, President and CEO of ADMA, emphasized the significance of this approval, stating that it represents a pivotal milestone for the company. He also highlighted the potential for accelerated revenue and earnings trajectory, beginning in late 2025 and extending into 2026 and beyond.

The company's internal research and development capabilities were acknowledged, with Grossman commending the team for driving the novel process from concept to approval with speed and capital efficiency. He also expressed gratitude to the FDA for its thorough and timely review, as well as its commitment to expanding immune globulin access for immunocompromised patients.

Looking ahead, ADMA Biologics is focused on advancing its internal research and development platform, optimizing production capabilities, and progressing novel pipeline programs, including SG-001, a pre-clinical investigative hyperimmune globulin targeting S. pneumonia.

This development underscores ADMA Biologics' commitment to product and process innovation, as it continues to position itself as a leader in modernizing and advancing plasma fractionation through agile, forward-thinking scientific development and execution.

The company, known for its dedication 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, is poised to leverage this approval to drive its growth trajectory and further solidify its position in the biopharmaceutical industry. Following these announcements, the company's shares moved 11.3%, and are now trading at a price of $24.33. For the full picture, make sure to review ADMA Biologics's 8-K report.

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