Kamada Announces FDA Approval of its New In-House Rabies Virus Neutralization Testing Laboratory

Kamada (NASDAQ: KMDA) received FDA approval for its new in-house Rapid Fluorescent Focus Inhibition Test (RFFIT) rabies virus neutralization laboratory at its Beit Kama, Israel plant.

Rhea-AI Summary

Kamada (NASDAQ: KMDA) received FDA approval for its new in-house Rapid Fluorescent Focus Inhibition Test (RFFIT) rabies virus neutralization laboratory at its Beit Kama, Israel plant. The lab expands Anti-Rabies potency testing for KEDRAB and KAMRAB, Kamada’s leading franchise with 2025 sales over $70 million.

The RFFIT lab is part of Kamada’s Quality Control network, is among a limited number of global facilities able to run this gold-standard test, and was also approved by Health Canada and the Israeli Ministry of Health.

Positive

• FDA approval of in-house RFFIT rabies neutralization testing laboratory
• RFFIT lab supports Anti-Rabies potency testing for KEDRAB and KAMRAB
• KEDRAB and KAMRAB 2025 sales totaled over $70 million
• Additional approvals from Health Canada and Israeli Ministry of Health
• In-house lab expected to enhance operational efficiencies per company

Negative

• None.

Argus Jun 1 session

-1.41% close to close Open Argus

Details

News Market Reaction – KMDA

On Jun 1, the day this news came out, KMDA closed 1.41% below the previous close.

Data tracked by StockTitan Argus for the Jun 1 session.

Market Context

This announcement highlights FDA approval of Kamada’s in-house RFFIT lab for rabies virus neutraliza...

Analysis

This announcement highlights FDA approval of Kamada’s in-house RFFIT lab for rabies virus neutralization testing, reinforcing quality control for KEDRAB and KAMRAB, which generated over $70M in 2025 sales. It extends a series of FDA approvals across Kamada’s plasma infrastructure. Investors may track how this capability supports the company’s 2026 guidance of $200M–$205M revenue and continued growth in its specialty plasma-derived portfolio.

Key Figures

KEDRAB & KAMRAB sales: over $70M 2025 Revenue: $180.5M 2025 Adjusted EBITDA: $42.0M +5 more

KEDRAB & KAMRAB sales

over $70M

2025 sales for anti-rabies products mentioned in article

2025 Revenue

$180.5M

Record 2025 results from recent filing

2025 Adjusted EBITDA

$42.0M

Record 2025 results from recent filing

2026 Revenue Guidance

$200M–$205M

Affirmed 2026 outlook in filings

2026 Adj. EBITDA Guidance

$50M–$53M

Affirmed 2026 outlook in filings

Q1 2026 Revenue

$45.2M

Most recent quarterly results

Q1 2026 Net Income

$4.1M

Most recent quarterly results

Q1 2026 Adjusted EBITDA

$11.6M

Most recent quarterly results, 26% margin

Previous Fda approval Reports

2 past events · Latest: Mar 26

Same Type 2 events

1. Mar 26

   FDA center approval

   24h Move

   +0.2%

   FDA cleared San Antonio plasma center for commercial plasma sales.

2. Aug 11

   FDA center approval

   24h Move

   +3.1%

   FDA approved Houston plasma center with large annual collection capacity.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

rapid fluorescent focus inhibition test, gmp, antibodies, plasma-derived therapies

4 terms

rapid fluorescent focus inhibition test medical

"new in-house Rapid Fluorescent Focus Inhibition Test (RFFIT) laboratory."

A rapid fluorescent focus inhibition test is a laboratory assay that measures how well a person’s or animal’s antibodies can block a virus—in most contexts, rabies—by mixing blood samples with virus and using a glowing dye to spot infected cells. Like a quick security drill that shows whether guards can stop an intruder, it provides a direct readout of immune protection; investors watch these results because they affect vaccine efficacy claims, regulatory approval, batch release, and market confidence.

gmp technical

"designed to meet stringent safety, quality and GMP standards."

Good Manufacturing Practice (GMP) is a set of regulatory standards and procedures that ensure products—especially medicines, medical devices, and related goods—are consistently made to meet safety, quality, and purity requirements. For investors, GMP compliance is like a factory’s hygiene and checklist system: it reduces the risk of product recalls, regulatory fines, and production stoppages, supports market access, and signals more reliable, lower-risk operations that can protect revenue and reputation.

antibodies medical

"gold standard neutralizing test used to measure the level of rabies-neutralizing antibodies."

Antibodies are proteins made by the body’s immune system that recognize and bind to specific foreign substances, like virus or bacteria pieces, much like a lock matched to a key. For investors, antibodies matter because they are the basis for diagnostic tests, vaccines and many therapies — changes in antibody data or the success of antibody-based products can directly affect a healthcare company’s revenue prospects and perceived value.

plasma-derived therapies medical

"leader in the specialty plasma-derived therapies field, today announced"

Plasma-derived therapies are medical products made from proteins extracted from donated blood plasma, used to treat immune deficiencies, bleeding disorders and other chronic conditions. Think of them like concentrated ingredients pulled from a large pot of soup to make a targeted remedy; their manufacture depends on steady donations, complex processing and strict regulation. For investors, that means revenue can be recurring and resilient but also sensitive to supply bottlenecks, regulatory changes and pricing pressures.

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

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REHOVOT, Israel and HOBOKEN, N.J., June 01, 2026 (GLOBE NEWSWIRE) -- Kamada Ltd. (NASDAQ: KMDA; TASE: KMDA.TA), 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 announced FDA approval of the Company’s new in-house Rapid Fluorescent Focus Inhibition Test (RFFIT) laboratory. RFFIT is the gold standard neutralizing test used to measure the level of rabies-neutralizing antibodies.

The new laboratory is part of Kamada’s Quality Control laboratory network and represents a significant expansion of the Company’s advanced testing capabilities for Anti-Rabies potency testing involved in the manufacture of KEDRAB^® and KAMRAB^®. The new laboratory is located in Kamada's plant in Beit Kama, Israel, and is one of a limited number of laboratories worldwide which can perform such tests. The new RFFIT laboratory was designed to meet stringent safety, quality and GMP standards. Prior to receiving the FDA approval, the laboratory was also approved by Health Canada and the Israeli Ministry of Health.

The RFFIT test is used by Kamada to quantify the Anti-Rabies potency throughout all key steps of KEDRAB and KAMRAB manufacturing from plasma collection and sourcing to final product release.

In 2025, Kamada’s sales of KEDRAB and KAMRAB totaled over $70 million, representing the leading franchise in the company’s portfolio of specialty plasma-derived products.

“Our new state-of-the-art RFFIT laboratory supports our continued progress as a leading global vertically integrated specialty plasma-derived company,” said Amir London, Kamada’s Chief Executive Officer. “The new laboratory will enable increased operational efficiencies through utilization of our in-house, highly professional capabilities supported by external testing expertise. The establishment of this lab is also a demonstration of our ongoing commitment to innovation, scientific excellence, and investment in advanced quality infrastructure.”

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.

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 new state-of-the-art RFFIT laboratory supports the Company’s continued progress as a leading global vertically integrated specialty plasma-derived company, 2) the expected benefits of the Company’s new in-house RFFIT laboratory, including increased operational efficiencies through utilization of the Company’s in-house highly professional capabilities supported by external testing expertise; and (3) the Company’s ongoing commitment to innovation, scientific excellence, and investment in advanced quality infrastructure. 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 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, effect of tariffs on overall international trade and specifically on sales of KEDRAB® and KAMRAB® 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 or furnished with the SEC and available at 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 update publicly 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

FAQ

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

What did Kamada (NASDAQ: KMDA) announce on June 1, 2026 about its rabies testing lab?

Kamada announced FDA approval of its new in-house RFFIT rabies virus neutralization testing laboratory. According to Kamada, the lab is part of its Quality Control network and expands testing capabilities for KEDRAB and KAMRAB at its Beit Kama, Israel manufacturing plant.

What is the purpose of Kamada’s new FDA-approved RFFIT laboratory for KEDRAB and KAMRAB?

The new RFFIT laboratory quantifies Anti-Rabies potency throughout key KEDRAB and KAMRAB manufacturing steps. According to Kamada, testing spans plasma collection, sourcing, and final product release, using the gold standard neutralizing assay for rabies-neutralizing antibodies to support product quality control.

How many 2025 sales did Kamada’s KEDRAB and KAMRAB franchise generate (KMDA)?

In 2025, KEDRAB and KAMRAB sales totaled over $70 million. According to Kamada, this Anti-Rabies portfolio represents the leading franchise within its specialty plasma-derived products, highlighting the strategic importance of the new in-house RFFIT testing laboratory.

Which regulators have approved Kamada’s new RFFIT rabies testing lab (KMDA)?

The RFFIT laboratory has been approved by the FDA, Health Canada, and the Israeli Ministry of Health. According to Kamada, the facility is among a limited number of labs worldwide capable of performing this rabies virus neutralization test under stringent safety and GMP standards.

How might Kamada’s in-house RFFIT lab affect its operations and quality control?

Kamada expects the in-house RFFIT lab to enable increased operational efficiencies. According to Kamada, internalizing this specialized rabies potency testing leverages its own professional capabilities, while still being supported by external testing expertise, and strengthens its advanced quality infrastructure.

Where is Kamada’s new FDA-approved rabies neutralization testing laboratory located?

The new RFFIT rabies neutralization testing laboratory is located at Kamada’s plant in Beit Kama, Israel. According to Kamada, this site forms part of its broader Quality Control laboratory network and supports Anti-Rabies potency testing for KEDRAB and KAMRAB manufacturing.