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Kamada says KedRAB can meet rising U.S. rabies demand

Kamada says its KedRAB production and inventory can support higher U.S. rabies post-exposure prophylaxis demand highlighted by a recent CDC advisory.

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Form Type
6-K

Rhea-AI Filing Summary

Kamada Ltd. (KMDA) reports that it has sufficient KedRAB human rabies immune globulin inventory and manufacturing capacity to meet increased demand in the United States. This follows a U.S. CDC Health Advisory on a significant nationwide year-over-year rise in human rabies exposures and rabies post-exposure prophylaxis use.

KedRAB, developed and manufactured by Kamada and supplied in the U.S. through Kedrion Biopharma Inc., is one of only two FDA-approved anti-rabies immunoglobulin products indicated for post-exposure prophylaxis. Kamada cites its vertically integrated supply chain, long-standing partnership with Kedrion, and recent FDA approval of its in-house rabies testing lab as positioning it to support higher demand while maintaining product quality and consistency.

The company notes CDC estimates that about 1.4 million people in the U.S. seek care annually for possible rabies exposure, with roughly 100,000 receiving post-exposure prophylaxis, and it estimates the total U.S. market for rabies immunoglobulin products at approximately $200 million per year. Kamada reiterates a growth strategy based on expanding its plasma-derived product portfolio, in-licensing in Israel and MENA, scaling plasma collection, and pursuing acquisitions and collaborations.

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Filing Explained

The September 17 Form 6-K adds its KedRAB supply announcement by incorporation into Kamada’s listed Form S-8 registration statements, making the disclosure part of those existing employee-equity filings; it does not state that shares were issued or sold.

Annual possible rabies exposures seeking care in U.S. 1,400,000 people CDC estimate of people seeking medical care for possible rabies exposure each year in the U.S.
Annual U.S. patients receiving rabies PEP 100,000 people CDC estimate of patients receiving post-exposure prophylaxis each year in the U.S.
Estimated U.S. rabies immunoglobulin market size $200 million per year Kamada estimate of total U.S. market for rabies immunoglobulin products
Controlling shareholder ownership 38% of outstanding ordinary shares FIMI Opportunity Funds’ beneficial ownership of Kamada
FDA-approved plasma collection centers 3 centers Number of Kamada-owned FDA-approved plasma collection centers in Beaumont, Houston, and San Antonio, Texas
post-exposure prophylaxis medical
"reporting a significant nationwide year-over-year increase in human rabies exposures and the use of rabies post-exposure prophylaxis"
A short course of medication or treatment given immediately after someone may have been exposed to an infectious agent to stop the infection from taking hold. Like applying a firewall after a suspected hacking attempt, it’s intended to prevent a small risk from becoming a full-blown problem. For investors, post-exposure prophylaxis matters because demand can spike suddenly after exposure events, regulatory approvals and efficacy data drive sales and valuation, and timely access or shortages affect market opportunity and reputational risk for healthcare providers and drug makers.
human rabies immune globulin medical
"KedRAB, a human rabies immune globulin developed and manufactured by Kamada"
A blood-derived medicine made from pooled human antibodies that is given after someone is exposed to rabies to provide immediate, short-term protection while the person’s own immune system responds to rabies vaccine. It is used together with and prior to vaccination in certain exposure cases and works like borrowing ready-made defenses until the body can make its own. Its relevance to investors lies in its status as a regulated, usually prescription-only biologic whose demand, pricing, manufacturing capacity and approvals affect company revenues and public-health supply chains.
hyper-immune plasma medical
"increasing demand for hyper-immune plasma"
forward-looking statements regulatory
"This release includes forward-looking statements within the meaning of Section 21E"
Forward-looking statements are predictions or plans that companies share about what they expect to happen in the future, like estimating sales or profits. They matter because they help investors understand a company's outlook, but since they are based on guesses and assumptions, they can sometimes be wrong.
Creutzfeldt-Jakob disease medical
"may carry a risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeld-Jacob disease (vCJD) agent"
A rare, rapidly progressive brain disorder caused by abnormally shaped proteins that damage brain tissue, producing severe dementia, loss of coordination and ultimately death; the abnormal proteins act like a bad copy that corrupts healthy ones. Investors care because cases or research breakthroughs can affect companies tied to diagnostics, treatments, food safety, animal health and regulatory oversight, influencing liability, supply chains and the valuation of firms working on related medical or safety solutions.

FAQ

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

What did Kamada Ltd. (KMDA) announce about KedRAB supply in the U.S.?

Kamada announced it has sufficient KedRAB inventory and manufacturing capacity to meet increased U.S. demand for rabies post-exposure prophylaxis, referencing a CDC advisory on a significant rise in rabies exposures and prophylaxis use.

How significant is the U.S. rabies exposure market referenced by KMDA?

The CDC estimates about 1.4 million people annually in the U.S. seek care for possible rabies exposure, with around 100,000 receiving post-exposure prophylaxis. Kamada estimates the U.S. rabies immunoglobulin market at approximately $200 million per year.

What is KedRAB and how is it positioned in the U.S. market?

KedRAB is a human rabies immune globulin indicated for passive, transient post-exposure prophylaxis in persons of all ages, given with rabies vaccine. It is described as one of only two FDA-approved anti-rabies immunoglobulin products for post-exposure prophylaxis in the U.S.

What recent regulatory development supports KMDA’s KedRAB capacity?

Kamada states that the recent FDA approval of its in-house rabies testing lab, alongside its vertically integrated supply chain and partnership with Kedrion, helps it respond to increased KedRAB demand while maintaining consistency and quality.

Who controls Kamada Ltd. (KMDA) according to the filing?

FIMI Opportunity Funds is identified as Kamada’s controlling shareholder, beneficially owning approximately 38% of the outstanding ordinary shares.

What are the main growth pillars in Kamada’s strategy mentioned in the 6-K?

Kamada describes four pillars: organic growth of its plasma-derived portfolio, distribution of third-party products in Israel and MENA, expansion of plasma collection (currently three FDA-approved U.S. centers), and pursuing mergers, acquisitions and collaborations to enhance its marketed portfolio.

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

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 6-K

 

Report of Foreign Private Issuer

Pursuant to Rule 13a-16 or 15d-16

of the Securities Exchange Act of 1934

 

For the Month of September 2026

 

Commission File Number 001-35948

 

Kamada Ltd.

(Translation of registrant’s name into English)

 

2 Holzman Street
Science Park, P.O. Box 4081
Rehovot 7670402
Israel
(Address of principal executive offices)

 

Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F.

 

Form 20-F ☒         Form 40-F ☐

 

 

 

 

 

This Form 6-K is being incorporated by reference into the Registrant’s Form S-8 Registration Statements, File Nos. 333-192720, 333-207933, 333-215983, 333-222891, 333-233267 and 333-265866.

 

The following exhibit is attached:

 

99.1   Kamada Confirms Sufficient KedRAB® Supply and Manufacturing Capacity to Meet Increased U.S. Demand

 

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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.

 

Date: September 17, 2026 KAMADA LTD.
   
  By: /s/ Nir Livneh
   

Nir Livneh

Vice President General Counsel and Corporate Secretary

 

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EXHIBIT INDEX

 

EXHIBIT NO.   DESCRIPTION
99.1   Kamada Confirms Sufficient KedRAB® Supply and Manufacturing Capacity to Meet Increased U.S. Demand

 

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Exhibit 99.1

 

CDC Highlights Significant Increase in U.S. Rabies Exposures and Anti-Rabies Immunoglobulin Utilization; Kamada Confirms Sufficient KedRAB® Supply to Meet Increased Demand

 

U.S. Centers for Disease Control and Prevention (CDC) Reports a Significant Year-Over-Year Increase in Nationwide Rabies Exposures and Rabies Immunoglobulin Utilization

 

KedRAB is One of Only Two FDA-Approved Anti-Rabies Immunoglobulin Products in the U.S. Market Estimated at $200 Million Annually

 

Kamada’s Manufacturing Capacity and Supply Availability Positioned to Support Increased Demand

 

REHOVOT, Israel, and HOBOKEN, NJ – September 17, 2026 – Kamada Ltd. (NASDAQ: KMDA; TASE: KMDA.TA) (the “Company”), a global biopharmaceutical company with a portfolio of marketed products indicated for rare and serious conditions and a leader in the specialty plasma-derived therapies field, today confirmed that it maintains sufficient KedRAB® supply and manufacturing capacity to meet increased demand for the product in the United States. The confirmation follows a Health Advisory published by the U.S. Centers for Disease Control and Prevention (CDC) on September 10, 2026, reporting a significant nationwide year-over-year increase in human rabies exposures and the use of rabies post-exposure prophylaxis (PEP). The CDC Health Advisory is available at https://www.cdc.gov/han/php/notices/han00533.html.

 

In light of this increase in end-user utilization described in the CDC advisory, Kamada confirms it has the inventory and manufacturing capacity to support the continued supply of KedRAB, a human rabies immune globulin developed and manufactured by Kamada, which is one of only two FDA-approved anti-rabies immunoglobulin products indicated for PEP treatment in the U.S. The product is supplied to the U.S. market via the Company’s U.S. commercialization partner, Kedrion Biopharma Inc.

 

“Kamada is a global leader in human rabies prevention using immunoglobulin and we remain committed to delivering reliable, uninterrupted supply of KedRAB to meet the needs of patients and clinicians across the United States,” said Amir London, Chief Executive Officer of Kamada. “Our long-standing successful partnership with Kedrion, together with our vertically integrated supply chain, and the recent FDA approval of our in-house rabies testing lab, position us to respond to this year-over-year increase in demand while maintaining the consistency and quality that this lifesaving therapeutic requires.”

 

Rabies is a deadly viral disease that attacks the brain and nervous system of mammals, including humans. The CDC estimates that approximately 1.4 million people in the United States seek medical care for a possible rabies exposure each year, of whom approximately 100,000 receive PEP treatment. Kamada estimates the total U.S. market for rabies immunoglobulin products at approximately $200 million annually.

 

INDICATION AND SELECTED IMPORTANT SAFETY INFORMATION

 

INDICATION: KEDRAB is a human rabies immune globulin (HRIG) indicated for passive, transient post-exposure prophylaxis of rabies infection to persons of all ages when given immediately after contact with a rabid or possibly rabid animal. KEDRAB should be administered concurrently with a full course of rabies vaccine.

 

 

 

IMPORTANT SAFETY INFORMATION ABOUT KedRAB: Severe hypersensitivity reactions, including anaphylaxis, may occur with KedRAB. IgA deficient patients with antibodies against IgA are at greater risk. Have epinephrine available immediately to treat any acute severe hypersensitivity reactions. KedRAB administration may interfere with the development of an immune response to live attenuated virus vaccines. If feasible, delay immunization with the measles vaccine for 4 months, and other live attenuated virus vaccines for three months, after KedRAB administration. A transient rise of the various passively transferred antibodies in the patient’s blood may result in misleading positive results of serologic tests after KedRAB administration. Passive transmission of antibodies to erythrocyte antigens, e.g., A, B, and D, may interfere with serologic tests for red cell antibodies such as the antiglobulin test (Coombs’ test). KedRAB is made from human plasma donors and may carry a risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeld-Jacob disease (vCJD) agent and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

 

To report SUSPECTED ADVERSE REACTIONS, contact Kedrion Biopharma Inc. at 1-855-353-7466 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

 

I.D. Code: KAM.001-26

 

About Kamada

 

Kamada Ltd. (the “Company”) is a global biopharmaceutical company with a portfolio of marketed products indicated for rare and serious conditions and a leader in the specialty plasma-derived therapies field. FIMI Opportunity Funds, the leading private equity firm in Israel, is the Company’s controlling shareholder, beneficially owning approximately 38% of the outstanding ordinary shares. The Company’s strategy is focused on driving profitable growth through four primary growth pillars: First, organic growth of its commercial portfolio, including continued investment in the commercialization and life cycle management of its proprietary products, consisting of six FDA-approved specialty plasma-derived products: KEDRAB®, GLASSIA®, CYTOGAM®, VARIZIG®, WINRHO SDF® and HEPAGAM B®, as well as KAMRAB®, and two equine-based anti-snake venom products. Second, distribution of third-parties’ pharmaceutical products in Israel & the MENA region through in-licensing partnerships, including the launch of several biosimilar products in Israel. Third, the Company is ramping up its plasma collection operations to support revenue growth through the sale of normal source plasma to other plasma-derived manufacturers, and to support its increasing demand for hyper-immune plasma. The Company currently owns three FDA-approved operating plasma collection centers in the United States, in Beaumont, Houston, and San Antonio, Texas. Fourth, the Company aims to secure new mergers and acquisitions, business development, in-licensing and/or collaboration opportunities, which are anticipated to enhance the Company’s marketed products portfolio and leverage its financial strength and existing commercial infrastructure to drive long-term profitable growth. The Company is leveraging its manufacturing, research and development expertise to advance the development and commercialization of additional product candidates, targeting areas of significant unmet medical need.

 

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Cautionary Note Regarding Forward-Looking Statements

 

This release includes forward-looking statements within the meaning of Section 21E of the U.S. Securities Exchange Act of 1934, as amended, and the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts, including statements regarding: (1) the sufficiency of the Company's KedRAB inventory and manufacturing capacity to meet current and future U.S. demand; and (2) expectations regarding continued or increased demand for KedRAB in the United States. Forward-looking statements are based on Kamada's current knowledge and its present beliefs and expectations regarding possible future events and are subject to risks, uncertainties and assumptions. Actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of several factors, including, but not limited to: the unpredictable and seasonal nature of rabies exposure trends and the possibility that reported increases in demand do not continue or recur; Kamada's reliance on Kedrion as its sole distributor of KedRAB in the United States and any change in that relationship; Kamada's ability to manufacture sufficient quantities of KedRAB and to obtain adequate quantities of hyper-immune plasma and other raw materials on a timely basis; competition from other rabies immunoglobulin and rabies biologic products; the evolving nature of the conflicts in the Middle East and the impact of such conflicts in Israel, the Middle East and the rest of the world; the impact of these conflicts on market conditions and the general economic, industry and political conditions in Israel, the U.S. and globally; the effect of tariffs on overall international trade and specifically on Kamada's ability to maintain expected sales and profit levels in light of such tariffs; the effect on the establishment and timing of business initiatives; Kamada’s ability to leverage new business opportunities and integrate them with its existing product portfolio; unexpected results of clinical and development programs; regulatory delays; and other risks detailed in Kamada's filings with the U.S. Securities and Exchange Commission (the “SEC”), including those discussed in its most recent Annual Report on Form 20-F and in any subsequent reports on Form 6-K, each of which is on file with, or furnished to, the SEC and available on the SEC’s website at www.sec.gov. The forward-looking statements made herein speak only as of the date of this announcement and Kamada undertakes no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law.

 

CONTACTS:

 

Chaime Orlev

Chief Financial Officer

IR@kamada.com

 

Brian Ritchie

 

LifeSci Advisors, LLC

212-915-2578

britchie@LifeSciAdvisors.com

 

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