RAMSEY, N.J. and BOCA RATON, Fla. - ADMA Biologics, Inc. (NASDAQ: NASDAQ:ADMA), a biopharmaceutical company, has received approval from the U.S. Food and Drug Administration (FDA) for supplemental Biologics License Applications (BLAs) for ASCENIV and BIVIGAM. This approval extends the room temperature storage conditions for these intravenous immune globulin products.
The FDA's approval now allows for a 4-week room temperature storage at any point during the 36-month approved shelf life for both ASCENIV and BIVIGAM. Previously, the room temperature storage condition was approved for the first 24 months of the product's shelf life. This new allowance applies to all existing and future production lots of ASCENIV and BIVIGAM.
The company's President and CEO, Adam Grossman, stated that the extended storage conditions are expected to improve inventory management and accessibility for healthcare providers, particularly those with limited refrigeration capabilities.
ASCENIV and BIVIGAM are plasma-derived treatments used for primary humoral immunodeficiency (PI), a group of genetic disorders that affect the immune system. The products contain antibodies that help protect patients from infections. The extended storage conditions are effective immediately, and the products are available to U.S. healthcare providers and patients.
ADMA Biologics operates an FDA-licensed plasma fractionation facility in Boca Raton, Florida, and through its subsidiary, ADMA BioCenters, it also collects source plasma for the manufacture of its products. The company holds a number of U.S. and foreign patents related to its products and product candidates.
The announcement is based on a press release statement.
InvestingPro Insights
ADMA Biologics, Inc. has recently garnered FDA approval for extended storage conditions of its immune globulin products, which could enhance the company's operational efficiencies and market accessibility. In light of this development, let's explore some key financial metrics and insights from InvestingPro that could further inform investors about ADMA's performance and outlook.
InvestingPro Data:
- As of the last twelve months ending Q4 2023, ADMA Biologics has seen a significant revenue growth of 67.59%, with the most recent quarterly growth at 47.86%.
- The company's gross profit margin in the same period stands at 35.26%, reflecting a solid ability to control the cost of goods sold relative to sales.
- ADMA's market capitalization is currently $1.45 billion, which is a testament to the company's scale in the biopharmaceutical industry.
InvestingPro Tips:
1. Analysts are optimistic about ADMA's future profitability, predicting that the company will become profitable this year.
2. The stock has experienced strong returns, with a 105.18% price total return over the last year, indicating robust investor confidence and market performance.
Investors seeking more detailed analysis and additional tips can find over 15 InvestingPro Tips for ADMA Biologics, including insights into valuation multiples and debt levels, at https://www.investing.com/pro/ADMA. For those interested in a deeper dive into ADMA's financials and potential investment opportunities, use the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription.
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