ADMA Biologics Announces FDA Approval to Expand the Label for ASCENIV™ to Include Pediatric Immune Compromised Patients Two Years of Age and Older

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.

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.

Argus May 4 session

-2.00% close to close Open Argus

Details

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.

Market Context

This announcement details FDA approval of an ASCENIV label expansion to include immune‑compromised p...

Analysis

This announcement details FDA approval of an ASCENIV label expansion to include immune‑compromised pediatric patients two years and older, versus the prior 12‑and‑up indication. It follows an earlier FDA process approval that improved production yields and supported ASCENIV’s growth. Investors monitoring this news often focus on future disclosures around pediatric uptake, real‑world safety, and how ASCENIV’s contribution evolves within ADMA’s broader plasma‑derived portfolio.

Key Figures

New minimum age: 2 years and older Previous minimum age: 12 years and older

New minimum age

2 years and older

Expanded ASCENIV indication for pediatric PI and immune compromised patients

Previous minimum age

12 years and older

Prior ASCENIV indication for primary humoral immunodeficiency

Previous Fda approval Reports

1 past event · Latest: Apr 28

Same Type 1 event

1. Apr 28

   FDA process approval

   24h Move

   +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.

Key Terms

biologics license application, section 351(a), public health service act, post marketing commitment, +2 more

6 terms

biologics license application regulatory

"the Company’s supplemental Biologics License Application (BLA) submitted under section 351(a)"

A biologics license application is a formal request submitted to regulatory authorities seeking approval to market a new biological medicine, such as vaccines or treatments made from living organisms. It is a comprehensive review process that evaluates the safety, effectiveness, and manufacturing quality of the product. For investors, receiving approval signals that a biological therapy can be sold to the public, potentially leading to revenue growth and market success.

section 351(a) regulatory

"supplemental Biologics License Application (BLA) submitted under section 351(a) of the Public Health Service Act"

A provision of U.S. tax law that lets people or businesses transfer assets to a corporation and receive stock in return without immediately paying tax, as long as the transferors collectively own at least 80% of the company right after the exchange. For investors, this matters because it enables tax-deferred corporate formations, reorganizations, or asset contributions—like rolling cash and property into a new company—so tax is postponed rather than realized immediately, which can affect return timing and post-transaction ownership stakes.

public health service act regulatory

"submitted under section 351(a) of the Public Health Service Act for ASCENIV™"

A public health service act is a law that gives government health agencies broad powers to prevent, respond to, and fund actions against disease outbreaks and other health emergencies. Investors care because those powers can change rules, speed approvals, unlock government purchases or funding, or limit liability for treatments and vaccines—similar to an emergency manager who can reassign resources and change how businesses operate during a crisis.

post marketing commitment regulatory

"represents the final study report for the Pediatric assessment as required in the post marketing commitment"

A post marketing commitment is a study or action a drug or medical-device maker agrees to carry out after a product is approved and sold, often to gather more safety, effectiveness, or manufacturing data. For investors, these commitments matter because their results can affect future sales, trigger label changes or safety alerts, and create additional costs or delays; think of it as a follow-up inspection that can change a product’s market prospects.

primary humoral immunodeficiency medical

"expand the primary humoral immunodeficiency (“PI”) indication to pediatric patients"

A primary humoral immunodeficiency is an inherited condition in which the body’s antibody-producing arm of the immune system is weak or missing, so people get frequent, sometimes severe infections. Think of it like a building whose fire alarms are faulty: occupants are at higher risk and need ongoing detection, prevention, and replacement therapies. For investors, it signals a medical need that drives demand for diagnosis, long-term treatments, and related healthcare services.

immune globulin medical

"offering our differentiated and patented immune globulin as an FDA-approved treatment option"

A laboratory-made preparation of antibodies collected from donated blood that is given to people to prevent or treat infections and immune system problems. Investors should care because immune globulin is a medicinal product with steady clinical demand, complex supply chains and regulation, and measurable pricing and reimbursement dynamics—think of it as a ready-made toolbox for the immune system whose availability and approval can drive a company’s revenue and risk profile.

AI-generated analysis. How Rhea-AI works. Not financial advice.

See more from StockTitan in Google Search and AI answers. Adds StockTitan as a preferred source · opens Google

Add on Google Not now

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 10% liquid) is a plasma-derived, polyclonal, intravenous immune globulin (IVIG). ASCENIV was approved by the United States Food and Drug Administration (FDA) in April 2019 and is indicated for the treatment of primary humoral immunodeficiency (PI), also known as primary immune deficiency disease (PIDD), in adults and pediatric patients 2 years of age and older. ASCENIV is manufactured using ADMA’s unique, patented plasma donor screening methodology and tailored plasma pooling design, which blends normal source plasma and respiratory syncytial virus (RSV) plasma obtained from donors tested using the Company’s proprietary microneutralization assay. ASCENIV contains naturally occurring polyclonal antibodies, which are proteins that are used by the body’s immune system to neutralize microbes such as bacteria and viruses that safeguard against infection and disease. ASCENIV is protected by numerous issued patents in the United States and internationally and a wide range of patent applications worldwide. Certain data and other information about ASCENIV can be found by visiting www.asceniv.com. Information about ADMA and its products can be found on the Company’s website at www.admabiologics.com. 

 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 (≥5% of study subjects) were headache, sinusitis, diarrhea, gastroenteritis viral, nasopharyngitis, upper respiratory tract infection, bronchitis, and nausea. 

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 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. Additionally, ADMA is developing SG-001, a pre-clinical, investigative hyperimmune globulin targeting S. pneumonia. ADMA manufactures its immune globulin products and product candidates at its FDA-licensed plasma fractionation and purification facility located in Boca Raton, Florida. Through its ADMA BioCenters subsidiary, ADMA also operates as an FDA-approved source plasma collector in the U.S., which provides its blood plasma for the manufacture of its products and product candidates. ADMA’s mission is to manufacture, market and develop specialty plasma-derived, human immune globulins targeted to niche patient populations for the treatment and prevention of certain infectious diseases and management of immune compromised patient populations who suffer from an underlying immune deficiency, or who may be immune compromised for other medical reasons. ADMA holds numerous U.S. and foreign patents related to and encompassing various aspects of its products and product candidates. For more information, please visit. www.admabiologics.com.

INVESTOR RELATIONS CONTACT:

Argot Partners | 212-600-1902 | ADMA@argotpartners.com

MEDIA CONTACT:

Longacre Square Partners | ADMABiologics@longacresquare.com

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did ADMA announce about ASCENIV on May 4, 2026 (ADMA)?

ADMA announced that the FDA approved a supplemental BLA expanding ASCENIV's PI indication to pediatric patients aged two years and older. According to the company, the approval represents the final pediatric assessment required as a post‑marketing commitment and updates prescribing information.

How does the ASCENIV label change for pediatric PI patients (ADMA)?

The label now covers pediatric primary humoral immunodeficiency patients aged two years and older, instead of 12 years and older. According to the company, this revision follows completion of the pediatric clinical program and the FDA's acceptance of the final study report.

Does the FDA approval for ASCENIV fulfill a post‑marketing requirement (ADMA)?

Yes. The FDA approval represents the final pediatric assessment required under the post‑marketing commitment. According to the company, the supplemental BLA submission satisfied the study requirement and led to the prescribing information revision.

What does the ASCENIV approval mean for younger immune‑compromised patients (ADMA)?

The approval allows ASCENIV to be prescribed for immune‑compromised pediatric patients aged two years and older with PI. According to the company, this expansion enables earlier treatment options for younger patients in need of immune globulin therapy.