ADMA Biologics Receives FDA Approval for ASCENIV™

Written by Emily J. Thompson, Senior Investment Analyst

Source: Newsfilter

Updated: 2 days ago

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Source: Newsfilter

FDA Approval Expansion: ADMA Biologics' ASCENIV™ has received FDA approval to expand the primary humoral immunodeficiency (PI) indication to pediatric patients aged two years and older, enabling the company to address treatment needs for younger immune-compromised patients earlier, thereby enhancing its market competitiveness.
Clinical Trial Success: This approval is based on the final study report for the pediatric assessment required under post-marketing commitments, reflecting the ADMA team's exceptional execution in complex clinical trials, which bolsters the company's reputation in the biopharmaceutical sector.
Product Background: ASCENIV™ is a 10% liquid human immune globulin specifically designed for treating immunodeficient patients, manufactured using ADMA's unique plasma donor screening and pooling design, ensuring product quality and safety, which further solidifies the company's market position.
Future Outlook: ADMA plans to actively expand the utilization of FDA-approved ASCENIV™ among immune-deficient pediatric patients, which is expected to drive future revenue growth and increase market share.

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About ADMA

ADMA Biologics, Inc. is an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty biologics for the treatment of immunodeficient patients at risk for infection and others at risk for certain infectious diseases. The Company manufactures and markets three United States Food and Drug Administration (FDA)-approved plasma-derived biologics for the treatment of immune deficiencies and the prevention of certain infectious diseases: ASCENIV (immune globulin intravenous, human-slra 10% liquid) for the treatment of primary humoral immunodeficiency (PI); BIVIGAM (immune globulin intravenous, human) for the treatment of PI; and NABI-HB (hepatitis B immune globulin, human) to provide enhanced immunity against the hepatitis B virus. Through its ADMA BioCenters subsidiary, the Company also operates as an FDA-approved source plasma collector in the United States, which provides its blood plasma for the manufacture of its products.

About the author

Emily J. Thompson

Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.

Investigation into ADMA Biologics for Securities Fraud

2 hours agoGlobenewswire

Investigation Announcement: Bleichmar Fonti & Auld LLP has initiated an investigation into ADMA Biologics for potential violations of federal securities laws, particularly concerning the authenticity of its reported 20% revenue growth in 2025, indicating significant legal risks for the company.
Revenue Growth Concerns: A report by Culper Research alleges that ADMA engaged in channel stuffing by incentivizing distributors to stockpile ASCENIV, which artificially inflated revenues; without this scheme, the company would have faced a 3% revenue decline in 2025, severely undermining investor confidence.
Stock Price Plummet: Following the investigation and the report's revelations, ADMA's stock price dropped 29% over two trading days, from $13.59 per share on March 23 to $9.63 on March 25, reflecting market concerns about the company's financial health and operational integrity.
Legal Options for Investors: Investors are encouraged to reach out to BFA for legal support, with the firm offering contingency-based representation, highlighting its commitment to safeguarding investor rights amidst these serious allegations.