ADMA Biologics Announces U.S. FDA Approval of Innovative Production Yield Enhancement Process

Core Insights - ADMA Biologics, Inc. has received U.S. FDA approval for an innovative yield enhancement production process, which is expected to increase production yields by approximately 20% from the same starting plasma volume [1][2] - This approval is anticipated to significantly accelerate the company's revenue and earnings trajectory starting in late 2025 and continuing into 2026 and beyond [2] - ADMA is the first U.S. producer of plasma-derived products to achieve regulatory approval for this innovative process, showcasing its leadership in modernizing plasma fractionation [2] Company Overview - ADMA Biologics is a U.S.-based biopharmaceutical company focused on manufacturing, marketing, and developing specialty biologics for immunodeficient patients and those at risk for infectious diseases [3] - The company currently markets three FDA-approved plasma-derived biologics: ASCENIV™, BIVIGAM®, and NABI-HB® [3] - ADMA is also developing SG-001, a pre-clinical hyperimmune globulin targeting S. pneumonia, demonstrating its commitment to product and process innovation [3] Production and R&D Capabilities - The innovative yield enhancement process is expected to benefit both ASCENIV and BIVIGAM, enhancing production output capacity [1] - ADMA operates an FDA-licensed plasma fractionation and purification facility in Boca Raton, Florida, and has a subsidiary, ADMA BioCenters, that collects source plasma for its products [3] - The company holds numerous U.S. and foreign patents related to its products and product candidates, reinforcing its competitive position in the market [3]