ADMA Biologics Announces FDA Approval to Expand the Label for ASCENIV™ to Include Pediatric Immune Compromised Patients Two Years of Age and Older
Rhea-AI Summary
ADMA Biologics (Nasdaq: ADMA) announced FDA approval (May 4, 2026) of a supplemental BLA for ASCENIV, expanding the primary humoral immunodeficiency (PI) indication to pediatric patients two years of age and older. The approval reflects the final pediatric assessment required as a post‑marketing commitment and revises ASCENIV prescribing information; the prior pediatric indication started at age 12.
The company said the expanded label enables treatment of younger PI and immune‑compromised patients and follows completion of the clinical program supporting the pediatric assessment.
Positive
- FDA expanded ASCENIV PI label to include pediatric patients aged 2 years and older
- Approval represents the final pediatric assessment fulfilling the post‑marketing commitment
- Previous pediatric indication limitation of 12 years+ removed, enabling earlier treatment
Negative
- None.
News Market Reaction – ADMA
In the May 4 session, ADMA declined 2.00%, reflecting a moderate negative market reaction.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Previous Fda approval Reports
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Apr 28 | FDA process approval | Positive | +12.1% | FDA cleared an innovative yield‑enhancement production process for ASCENIV and BIVIGAM. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
The last tagged FDA approval in Apr 2025 led to a 12.12% gain, indicating prior regulatory milestones have coincided with positive price reactions.
Over the past year, ADMA combined operational and regulatory milestones. A prior FDA approval in April 2025 for a yield‑enhancing production process supported both ASCENIV and BIVIGAM and was followed by a 12.12% gain. Since then, ASCENIV demand has been described as strong in filings, and the current pediatric label expansion further builds on ASCENIV’s role within the portfolio and the company’s broader FDA interaction history.
Key Terms
biologics license application regulatory
section 351(a) regulatory
public health service act regulatory
post marketing commitment regulatory
primary humoral immunodeficiency medical
immune globulin medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
RAMSEY, N.J. and BOCA RATON, Fla., May 04, 2026 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (Nasdaq: ADMA) (“ADMA” or the “Company”), a U.S. based, end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty biologics, today announced the U.S. Food and Drug Administration (“FDA”) has approved the Company’s supplemental Biologics License Application (BLA) submitted under section 351(a) 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 (“PI”) 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.
“This expanded label for ASCENIV allows ADMA to actively address the treatment needs of younger PI and immune compromised patients earlier in their treatment journey,” said Adam Grossman, President and Chief Executive Officer of ADMA. “In the periods ahead, we look forward to continuing to expand the utilization of ASCENIV by offering our differentiated and patented immune globulin as an FDA-approved treatment option for immune compromised pediatric patients in need.”
“We proudly recognize the extraordinary collaboration of the PI disease community and dedicated physicians, along with the courage and commitment of the children and families whose participation was essential in driving this clinical program forward,” said Kaitlin Kestenberg, Chief Operating Officer and Senior VP of Compliance. “Enrolling in and successfully completing these complex trials is a significant achievement, and this FDA approval reflects the strength of the clinical and operational execution of the devoted ADMA team.”
About ASCENIV™
ASCENIV (immune globulin intravenous, human – slra
Additional Important Safety Information About ASCENIV™
| WARNING: THROMBOSIS, RENAL DYSFUNCTION AND ACUTE RENAL FAILURE |
| Thrombosis may occur with immune globulin intravenous (IGIV) products, including ASCENIV. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity, and cardiovascular risk factors. Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur with the administration of IGIV products in predisposed patients. Such events require immediate medical intervention, if not recognized or managed appropriately, may result in persistent or significant disability or lead to fatal outcome. For patients at risk of thrombosis, renal dysfunction or renal failure, administer ASCENIV at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity. |
ASCENIV™ Contraindications:
History of anaphylactic or severe systemic reactions to human immunoglobulin.
IgA deficient patients with antibodies to IgA and a history of hypersensitivity.
ASCENIV™ Warnings and Precautions:
IgA-deficient patients with antibodies against IgA are at greater risk of developing severe hypersensitivity and anaphylactic reactions. Have medications such as epinephrine available to treat any acute severe hypersensitivity reactions. [4, 5.1]
Thrombotic events have occurred in patients receiving IGIV treatments. Monitor patients with known risk factors for thrombotic events; consider baseline assessment of blood viscosity for patients at risk of hyperviscosity. [5.2, 5.4]
In patients at risk of developing acute renal failure, monitor renal function, including blood urea nitrogen (BUN), serum creatinine, and urine output. [5.3, 5.9]
Hyperproteinemia, increased serum viscosity, and hyponatremia or pseudohyponatremia can occur in patients receiving IGIV treatment.
Aseptic meningitis syndrome (AMS) has been reported with IGIV treatments, especially with high doses or rapid infusion. [5.5]
Hemolytic anemia can develop subsequent to IGIV treatment. Monitor patients for hemolysis and hemolytic anemia. [5.6]
Monitor patients for pulmonary adverse reactions (Transfusion-related acute lung injury [TRALI]). If transfusion related acute lung injury is suspected, test the product and patient for antineutrophil antibodies. [5.7]
Because this product is made from human blood, it may carry a risk of transmitting infectious agents, e.g., viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent.
ASCENIV™ Adverse Reactions:
The most common adverse reactions to ASCENIV (≥
To report SUSPECTED ADVERSE REACTIONS, contact ADMA Biologics at (800) 458-4244 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
About ADMA Biologics, Inc. (ADMA)
ADMA Biologics is a U.S.-based, 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. ADMA currently 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
INVESTOR RELATIONS CONTACT:
Argot Partners | 212-600-1902 | ADMA@argotpartners.com
MEDIA CONTACT:
Longacre Square Partners | ADMABiologics@longacresquare.com
