[8-K] ADMA BIOLOGICS, INC. Reports Material Event
Filing Impact
Filing Sentiment
Form Type
8-K
Rhea-AI Filing Summary
ADMA Biologics reports a key regulatory milestone for its ASCENIV immune globulin therapy. The U.S. Food and Drug Administration has approved a supplemental Biologics License Application expanding ASCENIV’s primary humoral immunodeficiency indication to pediatric and adult patients two years of age and older, from a prior minimum age of 12 years. The approval also fulfills the required pediatric post‑marketing commitment and allows updated prescribing information. ASCENIV is a patented, plasma-derived intravenous immune globulin designed to provide antibodies against infections, supported by an established safety profile that includes boxed warnings and detailed precautions typical for IVIG products.
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Insights
FDA expands ASCENIV’s indication to younger pediatric PI patients.
The FDA approval broadens ASCENIV use in primary humoral immunodeficiency from patients aged 12 and older to those two years and older. This closes out a pediatric post‑marketing commitment and strengthens the product’s label with formal pediatric data.
For a commercial IVIG franchise like ADMA Biologics, a wider age range expands the population that can be treated within the same indication, particularly among immune‑compromised children who require chronic antibody replacement. This bolsters ASCENIV’s clinical positioning as a differentiated, patented immune globulin option.
The filing details ASCENIV’s manufacture from screened plasma, its polymicrobial antibody profile, and significant safety warnings, including thrombosis, renal dysfunction, hemolysis, TRALI, and infection transmission risks. Future company disclosures can further clarify how this broader label integrates into overall product utilization and portfolio strategy.
8-K Event Classification
2 items: 8.01, 9.01
2 items
Item 8.01
Other Events
Other
Voluntary disclosure of events the company deems important to shareholders but not covered by other items.
Item 9.01
Financial Statements and Exhibits
Exhibits
Financial statements, pro forma financial information, and exhibit attachments filed with this report.
Key Figures
New minimum ASCENIV age: 2 years and older
Previous minimum ASCENIV age: 12 years and older
ASCENIV initial FDA approval: April 2019
+1 more
4 metrics
New minimum ASCENIV age
2 years and older
Expanded primary humoral immunodeficiency indication
Previous minimum ASCENIV age
12 years and older
Prior PI indication before label expansion
ASCENIV initial FDA approval
April 2019
Original U.S. approval for primary humoral immunodeficiency
ASCENIV concentration
10% liquid
Plasma-derived intravenous immune globulin formulation
Key Terms
supplemental Biologics License Application, primary humoral immunodeficiency, immune globulin intravenous (IVIG), post marketing commitment, +2 more
6 terms
supplemental Biologics License Application regulatory
"has approved the Company’s supplemental Biologics License Application (BLA) submitted under section 351(a)"
A supplemental biologics license application is a formal request to a regulator (such as the U.S. Food and Drug Administration) asking permission to change an already approved biological product — for example to add a new use, change how it’s made, or alter dosing. For investors, an approved supplemental application can expand a product’s sales or reduce manufacturing risk, while a delay or rejection can limit revenue prospects or raise compliance costs; think of it like applying for an update to a building permit for an existing, income-producing property.
primary humoral immunodeficiency medical
"to expand the primary humoral immunodeficiency (“PI”) indication to pediatric patients two years of age and older"
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 intravenous (IVIG) medical
"ASCENIV (immune globulin intravenous, human – slra 10% liquid) is a plasma-derived, polyclonal, intravenous immune globulin (IVIG)"
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.
aseptic meningitis syndrome (AMS) medical
"Aseptic meningitis syndrome (AMS) has been reported with IGIV treatments, especially with high doses or rapid infusion"
Aseptic meningitis syndrome is inflammation of the thin membranes that cover the brain and spinal cord caused by non-bacterial triggers such as viruses, medications, or immune reactions, producing symptoms like headache, fever and neck stiffness. It matters to investors because reports of AMS can prompt safety reviews, clinical trial pauses, regulatory scrutiny or liability risk for health-care products—like a warning light that can slow or halt a company’s progress and affect valuation.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): May 4, 2026
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Registrant’s telephone number, including area code: (201 )
478-5552
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(Former name or former address, if changed since last report.)
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the
following provisions (see General Instruction A.2. below):
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Securities registered pursuant to Section 12(b) of the Act:
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Title of each class
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Trading Symbol(s)
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Name of each exchange on which
registered
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter)
or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or
revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
| Item 8.01 |
Other Events.
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On May 4, 2026, ADMA Biologics, Inc. (the “Company”) issued a press release announcing that the U.S. Food and Drug Administration has
approved the Company’s label expansion supplemental Biologics License Application for ASCENIVTM to include pediatric immune compromised patients two years of age and older. A copy of the press release is attached as Exhibit 99.1 and
incorporated by reference herein.
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Exhibits.
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(d) Exhibits
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Exhibit
No.
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Description
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99.1
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ADMA Biologics, Inc. Press Release, dated as of May 4, 2026
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104
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Cover Page Interactive Data File (embedded with the Inline XBRL document)
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SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its
behalf by the undersigned hereunto duly authorized.
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May 4, 2026
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ADMA Biologics, Inc.
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By:
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/s/ Adam S. Grossman
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Name:
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Adam S. Grossman
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Title:
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President and Chief Executive Officer
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Exhibit 99.1
ADMA Biologics Announces FDA Approval to Expand the Label for ASCENIVTM to Include Pediatric Immune
Compromised Patients Two Years of Age and Older
RAMSEY, N.J. and BOCA RATON, Fla., May 4, 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.
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Additional Important Safety Information About ASCENIV™
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WARNING: THROMBOSIS, RENAL DYSFUNCTION AND ACUTE RENAL FAILURE
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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.
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ASCENIV™ Contraindications:
History of anaphylactic or severe systemic reactions to human immunoglobulin.
IgA deficient patients with antibodies to IgA and a history of hypersensitivity.
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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.
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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
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