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ADMA Biologics Inc. (ADMA) is a commercial-stage biopharmaceutical company advancing plasma-derived therapies for immune deficiencies and infectious diseases. This dedicated news hub provides verified updates on corporate developments, regulatory milestones, and clinical progress.
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ADMA Biologics, Inc. (Nasdaq: ADMA) has announced on-demand access to an educational event at IDWeek 2021 focused on respiratory viral infections. Renowned experts Dr. Michael Ison and Dr. Jolan Walter highlighted the benefits of ASCENIV™, an intravenous immunoglobulin product, in treating pediatric patients with primary immunodeficiency and RSV. The presentation included two illustrative cases demonstrating ASCENIV's efficacy. Approved by the FDA in April 2019, ASCENIV is designed for treating primary humoral immunodeficiency and is backed by proprietary manufacturing methods.
ADMA Biologics has announced an exclusive educational event at IDWeek 2021, focusing on respiratory viral infections, including RSV. The event features expert discussions by Dr. Michael Ison and Dr. Jolan Walter addressing key clinical challenges and introducing ASCENIV™, a novel intravenous immunoglobulin. ASCENIV is FDA-approved for treating primary immune deficiency and is manufactured using a unique plasma donor screening methodology. The session will occur on October 1, 2021, from 1:00 PM to 1:45 PM ET at the IDWeek Learning Lounge.
ADMA Biologics (Nasdaq: ADMA) will participate in a virtual fireside chat at the Cantor Healthcare Conference on September 30, 2021, at 9:20 a.m. ET. Adam Grossman, President and CEO, will lead the discussion. A webcast of the event will be available on the company’s website and archived for 90 days. ADMA specializes in the manufacturing and marketing of plasma-derived biologics, currently offering three FDA-approved products for immunodeficient patients and those at risk of infectious diseases. The company operates an FDA-licensed facility in Boca Raton, Florida.
ADMA Biologics has received FDA approval for its in-house aseptic fill-finish machine, the VanRx SA25, marking a pivotal development in its supply chain strategy. This approval allows ADMA to handle internal fill-finish operations, improving gross margins, patient supply consistency, and reducing production cycle times. The VanRx's advanced design enhances operational control and visibility over product releases. Additionally, the approval opens doors for new contract manufacturing opportunities, positioning ADMA to potentially exceed its financial targets and sustain revenue growth.
ADMA Biologics, Inc. (Nasdaq: ADMA) announced that CEO Adam Grossman will participate in a virtual fireside chat at the Morgan Stanley 19th Annual Global Healthcare Conference on September 9, 2021, at 12:30 p.m. ET. A webcast of this event will be available on ADMA's website and will be archived for 90 days following the event. ADMA specializes in developing plasma-derived biologics aimed at treating immunodeficient patients and is known for FDA-approved products such as BIVIGAM®, ASCENIV™, and NABI-HB®.
ADMA Biologics, Inc. has received FDA approval for its ADMA BioCenters plasma collection facility in Maryville, Tennessee, enhancing its ability to collect human source plasma. This facility started operations in Q4 2020 and is now licensed to introduce plasma into interstate commerce. With a goal of operating 10+ FDA-approved centers by 2024, ADMA aims to secure plasma supply and control manufacturing operations. The center is equipped with advanced technology and aims to employ 50 staff at full capacity, while offering new donors competitive compensation for contributions.
ADMA Biologics reported a record total revenue of $17.8 million for Q2 2021, marking a 129% increase year-over-year, driven primarily by its intravenous immune globulin (IVIG) product portfolio. The company anticipates reaching an annualized revenue run rate of approximately $100 million by the end of 2021. Despite a net loss of $18.9 million for the quarter, improvements in revenue and gross margins were noted. Strategic initiatives, including an expanded production capacity and supply chain enhancements, position ADMA for continued growth and operational efficiencies in the future.
ADMA Biologics (NASDAQ: ADMA) has launched operations at its new plasma collection facility in Conyers, Georgia, marking a significant expansion in its BioCenters network. This center, now the eighth under ADMA, aims to enhance plasma collection efficiency with the introduction of Haemonetics’ Persona® Plasma Collection Solution, expected to increase yield by 9% to 12% per donation. ADMA plans to file a Biologics License Application for this facility in approximately three months, with full FDA review anticipated to take around 12 months. This development is poised to support ongoing revenue growth and profitability.
ADMA Biologics has expanded its commercial offering of Immune Globulin (IG) products by introducing additional vial sizes of BIVIGAM and NABI-HB, now available to U.S. healthcare providers.
These new sizes aim to enhance treatment flexibility, reduce drug wastage, and align with competitor offerings. The FDA has approved the 100 mL BIVIGAM vial, complementing the existing 50 mL option. ADMA anticipates that this broader range of vial configurations will facilitate targeted dosing and improve patient care.
ADMA Biologics, a biopharmaceutical company specializing in plasma-derived biologics, will announce its second-quarter financial results on August 11, 2021, after market close. A conference call will follow at 4:30 p.m. ET for discussion of the results and company updates. ADMA's products include ASCENIV™, BIVIGAM®, and NABI-HB®, all FDA-approved for treating immunodeficient patients. The company’s manufacturing is based in Boca Raton, Florida, and it operates FDA-approved plasma collection centers to support its production.
