Adma Biologics Asceniv Approved by FDA for Children Aged 2 and Older
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 2 days ago
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Should l Buy ADMA?
Adma Biologics announced the FDA has approved the company's supplemental biologics license application submitted under section 351 of the Public Health Service Act for Asceniv. The FDA approval represents the final study report for the Pediatric assessment as required in the post marketing commitment. Additionally, the approval provides for a revision of Asceniv's prescribing information to expand the primary humoral immunodeficiency indication to pediatric patients two years of age and older. Previously, the indication for Asceniv was restricted to PI patients aged 12 years and older.
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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
- 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.
See More
ADMA Biologics Receives FDA Approval for ASCENIV™
- 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.
See More
ADMA Biologics Under Investigation for Securities Fraud
- Investigation Announcement: Bleichmar Fonti & Auld LLP has initiated an investigation into ADMA Biologics for potential violations of federal securities laws, particularly questioning the legitimacy of its reported 20% revenue growth in 2025.
- Revenue Growth Concerns: A report by Culper Research alleges that ADMA engaged in channel stuffing by incentivizing distributors to stockpile ASCENIV, which artificially inflated revenue figures; without this scheme, the company would have faced a 3% revenue decline in 2025.
- Stock Price Plunge: Following the investigation news, ADMA's stock price plummeted by 29% over two trading days, dropping from $13.59 per share on March 23, 2026, to $9.63 per share on March 25, indicating significant market skepticism regarding the company's financial integrity.
- Legal Options for Investors: Investors are encouraged to reach out to BFA for legal assistance, with the firm offering representation on a contingency fee basis, highlighting its commitment to safeguarding investor rights.
See More
ADMA Biologics Faces Securities Investigation
- Investigation Launched: Rosen Law Firm has announced an investigation into ADMA Biologics for potential securities claims due to allegations of misleading business information, allowing affected shareholders to seek compensation without upfront costs.
- Significant Stock Drop: On March 24, 2026, ADMA Biologics shares plummeted by 16.6% after short seller Culper Research accused the company of channel stuffing to inflate revenue, severely impacting investor confidence.
- Class Action Preparation: The Rosen Law Firm is preparing a class action lawsuit aimed at recovering investor losses, with no out-of-pocket fees for participants, thereby reducing the financial risk associated with joining the lawsuit.
- Firm's Track Record: Rosen Law Firm is recognized for its success in securities class actions, having recovered over $438 million for investors in 2019 alone, highlighting its expertise and resource advantages in handling such cases.
See More
Rosen Law Firm Investigates ADMA Biologics for Misleading Information
- Securities Claims Investigation: Rosen Law Firm has launched an investigation into ADMA Biologics due to allegations of issuing materially misleading business information, which could severely impact the company's reputation and stock price if proven true.
- Stock Price Plunge: On March 24, 2026, ADMA Biologics' shares fell by 16.6% after short seller Culper Research alleged that the company engaged in channel stuffing to inflate revenue, indicating a significant loss of market confidence in the company's financial transparency.
- Class Action Preparation: The Rosen Law Firm is preparing a class action to recover investor losses, with no upfront costs for participants, thereby reducing legal risks for investors and encouraging more affected parties to join the lawsuit.
- Firm's Track Record: Rosen Law Firm is renowned for its success in securities class actions, having recovered over $438 million for investors in 2019 alone, showcasing its expertise and resource advantages in handling similar cases.
See More
ADMA Biologics Under Investigation for Securities Violations
- Investigation Background: Bleichmar Fonti & Auld LLP has announced an investigation into ADMA Biologics for potential violations of federal securities laws, focusing on allegations that the reported 20% revenue growth in 2025 was a result of a channel stuffing scheme to mask declining demand.
- Revenue Growth Scrutiny: A report by Culper Research revealed that ADMA allegedly induced a distributor to stockpile ASCENIV by offering rebates and extended payment terms, which allowed the company to inflate revenue figures; without this scheme, the company would have faced a 3% revenue decline in 2025 instead of the reported growth.
- Stock Price Plunge: The news of the investigation caused ADMA's stock to drop 29% over two trading days, falling from $13.59 per share on March 23, 2026, to $9.63 per share on March 25, indicating significant market concerns regarding the company's financial health.
- Legal Options for Investors: Investors are encouraged to contact BFA for legal support, with the firm offering representation on a contingency fee basis, highlighting its commitment to protecting shareholder rights.
See More
Investigation into ADMA Biologics for Securities Fraud
- 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.
See More
ADMA Biologics Receives FDA Approval for ASCENIV™
- 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.
See More
ADMA Biologics Under Investigation for Securities Fraud
- Investigation Announcement: Bleichmar Fonti & Auld LLP has initiated an investigation into ADMA Biologics for potential violations of federal securities laws, particularly questioning the legitimacy of its reported 20% revenue growth in 2025.
- Revenue Growth Concerns: A report by Culper Research alleges that ADMA engaged in channel stuffing by incentivizing distributors to stockpile ASCENIV, which artificially inflated revenue figures; without this scheme, the company would have faced a 3% revenue decline in 2025.
- Stock Price Plunge: Following the investigation news, ADMA's stock price plummeted by 29% over two trading days, dropping from $13.59 per share on March 23, 2026, to $9.63 per share on March 25, indicating significant market skepticism regarding the company's financial integrity.
- Legal Options for Investors: Investors are encouraged to reach out to BFA for legal assistance, with the firm offering representation on a contingency fee basis, highlighting its commitment to safeguarding investor rights.
See More
ADMA Biologics Faces Securities Investigation
- Investigation Launched: Rosen Law Firm has announced an investigation into ADMA Biologics for potential securities claims due to allegations of misleading business information, allowing affected shareholders to seek compensation without upfront costs.
- Significant Stock Drop: On March 24, 2026, ADMA Biologics shares plummeted by 16.6% after short seller Culper Research accused the company of channel stuffing to inflate revenue, severely impacting investor confidence.
- Class Action Preparation: The Rosen Law Firm is preparing a class action lawsuit aimed at recovering investor losses, with no out-of-pocket fees for participants, thereby reducing the financial risk associated with joining the lawsuit.
- Firm's Track Record: Rosen Law Firm is recognized for its success in securities class actions, having recovered over $438 million for investors in 2019 alone, highlighting its expertise and resource advantages in handling such cases.
See More
Rosen Law Firm Investigates ADMA Biologics for Misleading Information
- Securities Claims Investigation: Rosen Law Firm has launched an investigation into ADMA Biologics due to allegations of issuing materially misleading business information, which could severely impact the company's reputation and stock price if proven true.
- Stock Price Plunge: On March 24, 2026, ADMA Biologics' shares fell by 16.6% after short seller Culper Research alleged that the company engaged in channel stuffing to inflate revenue, indicating a significant loss of market confidence in the company's financial transparency.
- Class Action Preparation: The Rosen Law Firm is preparing a class action to recover investor losses, with no upfront costs for participants, thereby reducing legal risks for investors and encouraging more affected parties to join the lawsuit.
- Firm's Track Record: Rosen Law Firm is renowned for its success in securities class actions, having recovered over $438 million for investors in 2019 alone, showcasing its expertise and resource advantages in handling similar cases.
See More
ADMA Biologics Under Investigation for Securities Violations
- Investigation Background: Bleichmar Fonti & Auld LLP has announced an investigation into ADMA Biologics for potential violations of federal securities laws, focusing on allegations that the reported 20% revenue growth in 2025 was a result of a channel stuffing scheme to mask declining demand.
- Revenue Growth Scrutiny: A report by Culper Research revealed that ADMA allegedly induced a distributor to stockpile ASCENIV by offering rebates and extended payment terms, which allowed the company to inflate revenue figures; without this scheme, the company would have faced a 3% revenue decline in 2025 instead of the reported growth.
- Stock Price Plunge: The news of the investigation caused ADMA's stock to drop 29% over two trading days, falling from $13.59 per share on March 23, 2026, to $9.63 per share on March 25, indicating significant market concerns regarding the company's financial health.
- Legal Options for Investors: Investors are encouraged to contact BFA for legal support, with the firm offering representation on a contingency fee basis, highlighting its commitment to protecting shareholder rights.
See More
