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ADMA Biologics Announces U.S. FDA Approval of Innovative Production Yield Enhancement Process
Approval Supports Revenue Growth and Margin Expansion Opportunity, and Substantially Increases Peak Production Output Capacity First U.S. Regulatory Approval
About this update from Adma Biologics Inc
[{"type":"text","content":"Approval Supports Revenue Growth and Margin Expansion Opportunity, and Substantially Increases Peak Production Output Capacity First U.S. Regulatory Approval of Innovative IG Yield Enhancement Process Highlights ADMA’s Uniquely Efficient Internal R&D Engine, Spanning Production and Product Development Capabilities Anticipate Approximately 20% Production Output Enhancement from Same Starting Plasma Volume The 20% Yield Enhancement Will Benefit Both ASCENIV and BIVIGAM RAMSEY, N.J. and BOCA RATON, Fla., April 28, 2025 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (Nasdaq: ADMA) (“ADMA” or the “Company”), a U.S. based, end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty biologics, today announced U.S. FDA approval of its innovative yield enhancement production process. This innovative process has demonstrated an ability to increase production yields by approximately 20% from the same starting plasma volume. “This approval represents a pivotal milestone for ADMA, unlocking the opportunity for meaningful acceleration in our revenue and earnings trajectory beginning in late 2025 and accelerating further into 2026 and beyond,” said Adam Grossman, President and Chief Executive Officer of ADMA. “As the first U.S. producer of plasma-derived products to achieve regulatory approval for its innovative yield enhancement production process, ADMA continues to demonstrate its leadership in modernizing and advancing plasma fractionation through agile, forward-thinking scientific development and execution. We commend our team for driving this novel process from concept to approval with speed and capital efficiency, and we thank the FDA for its thorough and timely review as well as the Agency’s commitment to expanding immune globulin access for immunocompromised patients. Looking ahead, we are excited to continue to advance our internal R&D platform—further optimizing production capabilities and progressing novel pipeline programs, most notably SG-001, our pre-clinical, investigative hyperimmune globulin targeting S. pneumonia, which exemplify our commitment to product and process innovation.” About ADMA Biologics, Inc. (ADMA) ADMA Biologics is a U.S. based, end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty biologics for the treatment ...