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Monday, April 28, 2025

ADMA Biologics FDA Approval of Innovative Plasma Production Yield Enhancement Process



ADMA Biologics (Nasdaq: ADMA) has received FDA approval for its innovative yield enhancement production process, marking a significant milestone for the biopharmaceutical company. The new process demonstrates an ability to increase production yields by approximately 20% from the same starting plasma volume, benefiting both ASCENIV and BIVIGAM products.

As the first U.S. producer of plasma-derived products to achieve this regulatory approval, ADMA expects meaningful acceleration in revenue and earnings trajectory beginning in late 2025 and accelerating into 2026. The company's internal R&D platform continues to advance, with ongoing development of novel pipeline programs including SG-001, a pre-clinical hyperimmune globulin targeting S. pneumonia.

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